Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-28 @ 6:56 AM
Study NCT ID:
NCT04109066
Status:
COMPLETED
Last Update Posted:
2025-01-08
First Post:
2019-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077594', 'term': 'Nivolumab'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinical.Trials@bms.com', 'phone': 'Please Email', 'title': 'Bristol-Myers Squibb Study Director', 'organization': 'Bristol-Myers Squibb'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 41 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 21 months).', 'description': 'The number at Risk for All-Cause Mortality represents all Randomized Participants based on the treatment received. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.\n\nThe 2 participants planned for Arm B treatment but received Arm A treatment are accounted for in the Arm A groups.', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A: Nivo + Chemo (PTX QW + AC Q3W) / Nivo + ET', 'description': 'Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:\n\nPaclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW\n\nFollowed by:\n\nAnthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q3W):\n\nNivolumab 360 mg Q3W + AC Q3W\n\nSurgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:\n\nAdjuvant Cycles 1-7 (1 cycle = Q4W):\n\nNivolumab 480 mg Q4W + Endocrine Therapy (ET)', 'otherNumAtRisk': 127, 'deathsNumAtRisk': 129, 'otherNumAffected': 126, 'seriousNumAtRisk': 127, 'deathsNumAffected': 8, 'seriousNumAffected': 38}, {'id': 'EG001', 'title': 'Arm A: Nivo + Chemo (PTX QW + AC Q2W) / Nivo + ET', 'description': 'Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:\n\nPaclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW\n\nFollowed by:\n\nAnthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W):\n\nNivolumab 240 mg Q2W + AC Q2W\n\nSurgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:\n\nAdjuvant Cycles 1-7 (1 cycle = Q4W):\n\nNivolumab 480 mg Q4W + Endocrine Therapy (ET)', 'otherNumAtRisk': 135, 'deathsNumAtRisk': 136, 'otherNumAffected': 132, 'seriousNumAtRisk': 135, 'deathsNumAffected': 7, 'seriousNumAffected': 51}, {'id': 'EG002', 'title': 'Arm B: Nivo Placebo + Chemo (PTX QW + AC Q3W) / ET', 'description': 'Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:\n\nPaclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW\n\nFollowed by:\n\nAnthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q3W):\n\nNivolumab Placebo Q3W + AC Q3W\n\nSurgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:\n\nAdjuvant Cycles 1-7 (1 cycle = Q4W):\n\nEndocrine Therapy (ET)', 'otherNumAtRisk': 123, 'deathsNumAtRisk': 124, 'otherNumAffected': 120, 'seriousNumAtRisk': 123, 'deathsNumAffected': 4, 'seriousNumAffected': 20}, {'id': 'EG003', 'title': 'Arm B: Nivo Placebo + Chemo (PTX QW + AC Q2W) / ET', 'description': 'Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:\n\nPaclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW\n\nFollowed by:\n\nAnthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W):\n\nNivolumab Placebo Q2W + AC Q2W\n\nSurgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:\n\nAdjuvant Cycles 1-7 (1 cycle = Q4W):\n\nEndocrine Therapy (ET)', 'otherNumAtRisk': 132, 'deathsNumAtRisk': 132, 'otherNumAffected': 130, 'seriousNumAtRisk': 132, 'deathsNumAffected': 4, 'seriousNumAffected': 26}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 65}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 62}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 24}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 7}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Adrenal insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 5}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 5}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 11}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Lacrimation increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 40}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 77}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 55}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 59}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 67}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 24}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 52}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 19}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 8}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 29}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 12}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Radiation skin injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 20}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 20}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 19}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 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'EG002', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Arterial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 127, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 135, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 123, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 132, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '26.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pathological Complete Response (pCR) Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:\n\nPaclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW\n\nFollowed by:\n\nAnthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):\n\nNivolumab 360 mg Q3W + AC Q3W or Nivolumab 240 mg Q2W + AC Q2W\n\nSurgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:\n\nAdjuvant Cycles 1-7 (1 cycle = Q4W):\n\nNivolumab 480 mg Q4W + Endocrine Therapy (ET)'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:\n\nPaclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW\n\nFollowed by:\n\nAnthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):\n\nNivolumab Placebo Q3W + AC Q3W or Nivolumab Placebo Q2W + AC Q2W\n\nSurgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:\n\nAdjuvant Cycles 1-7 (1 cycle = Q4W):\n\nEndocrine Therapy (ET)'}], 'classes': [{'categories': [{'measurements': [{'value': '24.5', 'groupId': 'OG000', 'lowerLimit': '19.4', 'upperLimit': '30.2'}, {'value': '13.8', 'groupId': 'OG001', 'lowerLimit': '9.8', 'upperLimit': '18.7'}]}]}], 'analyses': [{'pValue': '0.0021', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.05', 'ciLowerLimit': '1.29', 'ciUpperLimit': '3.27', 'estimateComment': 'Stratified by PD-L1 by SP142 (\\< 1% vs. \\>= 1%), AC Dose-Frequency Chemotherapy Regimen (Q2W vs. Q3W) per IRT.\n\nStrata adjusted odds ratio (Arm A over Arm B) using Mantel-Haenszel method.', 'groupDescription': 'Arm A over Arm B', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference of pCR Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.5', 'ciLowerLimit': '4.0', 'ciUpperLimit': '16.9', 'estimateComment': 'Strata adjusted difference in pCR (Arm A-B) based on Cochran-Mantel-Haenszel (CMH) method of weighting.\n\nStratified by PD-L1 by SP142 (\\< 1% vs. \\>= 1%), AC Dose-Frequency Chemotherapy Regimen (Q2W vs. Q3W) per IRT.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 37 months', 'description': 'pCR rate is defined as the percentage of participants who achieved pCR. pCR is defined as no invasive residual disease in breast and lymph nodes performed by a local pathologist. Criteria for evaluation of pCR includes the following: pCR in breast, axillary lymph nodes and non-axillary sentinel node; no histologic evidence of invasive tumor cells; and pCR in the breast.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with sufficient follow-up for pCR assessment'}, {'type': 'SECONDARY', 'title': 'Pathological Complete Response (pCR) Rate (PD-L1 >=1%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:\n\nPaclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW\n\nFollowed by:\n\nAnthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):\n\nNivolumab 360 mg Q3W + AC Q3W or Nivolumab 240 mg Q2W + AC Q2W\n\nSurgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:\n\nAdjuvant Cycles 1-7 (1 cycle = Q4W):\n\nNivolumab 480 mg Q4W + Endocrine Therapy (ET)'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:\n\nPaclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW\n\nFollowed by:\n\nAnthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):\n\nNivolumab Placebo Q3W + AC Q3W or Nivolumab Placebo Q2W + AC Q2W\n\nSurgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:\n\nAdjuvant Cycles 1-7 (1 cycle = Q4W):\n\nEndocrine Therapy (ET)'}], 'classes': [{'categories': [{'measurements': [{'value': '44.3', 'groupId': 'OG000', 'lowerLimit': '33.7', 'upperLimit': '55.3'}, {'value': '20.2', 'groupId': 'OG001', 'lowerLimit': '12.3', 'upperLimit': '30.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.11', 'ciLowerLimit': '1.58', 'ciUpperLimit': '6.11', 'estimateComment': 'Stratified by AC Dose-Frequency. Chemotherapy Regimen (Q2W vs. Q3W) per IRT. Strata adjusted odds ratio (Arm A over Arm B) using Mantel-Haenszel method.', 'groupDescription': 'Arm A over Arm B', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference of pCR Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.1', 'ciLowerLimit': '10.7', 'ciUpperLimit': '37.5', 'estimateComment': 'Strata adjusted difference in pCR (Arm A-B) based on Cochran-Mantel-Haenszel (CMH) method of weighting.\n\nStratified by AC Dose-Frequency Chemotherapy Regimen (Q2W vs. Q3W) per IRT.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 37 months', 'description': 'pCR rate is defined as the percentage of participants who achieved pCR. pCR is defined as no invasive residual disease in breast and lymph nodes performed by a local pathologist. Criteria for evaluation of pCR includes the following: pCR in breast, axillary lymph nodes and non-axillary sentinel node; no histologic evidence of invasive tumor cells; and pCR in the breast.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in PD-L1 expression on immune cells \\>=1% subgroup with sufficient follow-up for pCR assessment'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Residual Cancer Burden (RCB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:\n\nPaclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW\n\nFollowed by:\n\nAnthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):\n\nNivolumab 360 mg Q3W + AC Q3W or Nivolumab 240 mg Q2W + AC Q2W\n\nSurgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:\n\nAdjuvant Cycles 1-7 (1 cycle = Q4W):\n\nNivolumab 480 mg Q4W + Endocrine Therapy (ET)'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:\n\nPaclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW\n\nFollowed by:\n\nAnthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):\n\nNivolumab Placebo Q3W + AC Q3W or Nivolumab Placebo Q2W + AC Q2W\n\nSurgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:\n\nAdjuvant Cycles 1-7 (1 cycle = Q4W):\n\nEndocrine Therapy (ET)'}], 'classes': [{'title': 'RCB-0', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'RCB-I', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'RCB-II', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}, {'title': 'RCB-III', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 37 months', 'description': 'RCB is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. RCB is categorized into the following 4 classes: RCB-0: no residual disease; RCB-1: minimal residual disease; RCB-II: moderate residual disease; RCB-III: and extensive residual disease.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants with sufficient follow-up for RCB assessment'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Residual Cancer Burden (RCB) PD-L1 >=1%', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:\n\nPaclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW\n\nFollowed by:\n\nAnthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):\n\nNivolumab 360 mg Q3W + AC Q3W or Nivolumab 240 mg Q2W + AC Q2W\n\nSurgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:\n\nAdjuvant Cycles 1-7 (1 cycle = Q4W):\n\nNivolumab 480 mg Q4W + Endocrine Therapy (ET)'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:\n\nPaclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW\n\nFollowed by:\n\nAnthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):\n\nNivolumab Placebo Q3W + AC Q3W or Nivolumab Placebo Q2W + AC Q2W\n\nSurgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:\n\nAdjuvant Cycles 1-7 (1 cycle = Q4W):\n\nEndocrine Therapy (ET)'}], 'classes': [{'title': 'RCB-0', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'RCB-I', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'RCB-II', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'RCB-III', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 37 months', 'description': 'RCB is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. RCB is categorized into the following 4 classes: RCB-0: no residual disease; RCB-1: minimal residual disease; RCB-II: moderate residual disease; RCB-III: and extensive residual disease.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in PD-L1 expression on immune cells \\>=1% subgroup with sufficient follow-up for RCB assessment'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:\n\nPaclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW\n\nFollowed by:\n\nAnthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):\n\nNivolumab 360 mg Q3W + AC Q3W or Nivolumab 240 mg Q2W + AC Q2W\n\nSurgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:\n\nAdjuvant Cycles 1-7 (1 cycle = Q4W):\n\nNivolumab 480 mg Q4W + Endocrine Therapy (ET)'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:\n\nPaclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW\n\nFollowed by:\n\nAnthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):\n\nNivolumab Placebo Q3W + AC Q3W or Nivolumab Placebo Q2W + AC Q2W\n\nSurgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:\n\nAdjuvant Cycles 1-7 (1 cycle = Q4W):\n\nEndocrine Therapy (ET)'}], 'classes': [{'title': 'Adverse Events (AEs)', 'categories': [{'measurements': [{'value': '259', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}]}]}, {'title': 'Drug-Related AEs', 'categories': [{'measurements': [{'value': '254', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}]}, {'title': 'AEs leading to discontinuation', 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days post last dose of neoadjuvant or adjuvant study therapy (Up to approximately 19 months)', 'description': 'Number of participants with any grade adverse events (AEs). An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relation with this treatment. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:\n\nPaclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW\n\nFollowed by:\n\nAnthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):\n\nNivolumab 360 mg Q3W + AC Q3W or Nivolumab 240 mg Q2W + AC Q2W\n\nSurgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:\n\nAdjuvant Cycles 1-7 (1 cycle = Q4W):\n\nNivolumab 480 mg Q4W + Endocrine Therapy (ET)'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:\n\nPaclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW\n\nFollowed by:\n\nAnthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):\n\nNivolumab Placebo Q3W + AC Q3W or Nivolumab Placebo Q2W + AC Q2W\n\nSurgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:\n\nAdjuvant Cycles 1-7 (1 cycle = Q4W):\n\nEndocrine Therapy (ET)'}], 'classes': [{'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose to 30 days post last dose of neoadjuvant or adjuvant study therapy (Up to approximately 19 months)', 'description': 'Number of participants with any grade serious adverse events (SAE). SAE is defined as any untoward medical occurrence that, at any dose: Results in death; is life threatening; requires inpatient hospitalization; results in persistent or significant disability; is a congenital anomaly/birth defect. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Died', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A', 'description': 'Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:\n\nPaclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW\n\nFollowed by:\n\nAnthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):\n\nNivolumab 360 mg Q3W + AC Q3W or Nivolumab 240 mg Q2W + AC Q2W\n\nSurgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:\n\nAdjuvant Cycles 1-7 (1 cycle = Q4W):\n\nNivolumab 480 mg Q4W + Endocrine Therapy (ET)'}, {'id': 'OG001', 'title': 'Arm B', 'description': 'Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:\n\nPaclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW\n\nFollowed by:\n\nAnthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):\n\nNivolumab Placebo Q3W + AC Q3W or Nivolumab Placebo Q2W + AC Q2W\n\nSurgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:\n\nAdjuvant Cycles 1-7 (1 cycle = Q4W):\n\nEndocrine Therapy (ET)'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to approximately 41 months', 'description': 'Number of participants who died due to any cause.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A', 'description': 'Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:\n\nPaclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW\n\nFollowed by:\n\nAnthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):\n\nNivolumab 360 mg Q3W + AC Q3W or Nivolumab 240 mg Q2W + AC Q2W\n\nSurgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:\n\nAdjuvant Cycles 1-7 (1 cycle = Q4W):\n\nNivolumab 480 mg Q4W + Endocrine Therapy (ET)'}, {'id': 'FG001', 'title': 'Arm B', 'description': 'Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:\n\nPaclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW\n\nFollowed by:\n\nAnthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):\n\nNivolumab Placebo Q3W + AC Q3W or Nivolumab Placebo Q2W + AC Q2W\n\nSurgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:\n\nAdjuvant Cycles 1-7 (1 cycle = Q4W):\n\nEndocrine Therapy (ET)'}], 'periods': [{'title': 'Pre-treatment', 'milestones': [{'type': 'STARTED', 'comment': 'Started = Randomized', 'achievements': [{'groupId': 'FG000', 'numSubjects': '263'}, {'groupId': 'FG001', 'numSubjects': '258'}]}, {'type': 'COMPLETED', 'comment': 'Completed = Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '260'}, {'groupId': 'FG001', 'numSubjects': '257'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Participant withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Participant no longer meets study criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Treatment', 'milestones': [{'type': 'STARTED', 'comment': 'Started = Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '260'}, {'groupId': 'FG001', 'numSubjects': '257'}]}, {'type': 'Received Arm A Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Planned for Arm B treatment but received Arm A treatment.', 'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '167'}, {'groupId': 'FG001', 'numSubjects': '174'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}, {'groupId': 'FG001', 'numSubjects': '83'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Participant request to discontinue Study treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Participant no longer meets study criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Administrative reasons by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Study drug toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Adverse Event unrelated to Study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Disease Recurrence', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Not reported', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}], 'preAssignmentDetails': '2 Participants planned for Arm B treatment received Arm A treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'BG000'}, {'value': '258', 'groupId': 'BG001'}, {'value': '521', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A', 'description': 'Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:\n\nPaclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab 360 mg Q3W + PTX QW\n\nFollowed by:\n\nAnthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):\n\nNivolumab 360 mg Q3W + AC Q3W or Nivolumab 240 mg Q2W + AC Q2W\n\nSurgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:\n\nAdjuvant Cycles 1-7 (1 cycle = Q4W):\n\nNivolumab 480 mg Q4W + Endocrine Therapy (ET)'}, {'id': 'BG001', 'title': 'Arm B', 'description': 'Neoadjuvant (Pre-surgery) Phase 8 cycles maximum:\n\nPaclitaxel (PTX) Cycles 1-4 (1 cycle = Q3W): Nivolumab Placebo Q3W + PTX QW\n\nFollowed by:\n\nAnthracycline-Cyclophosphamide (AC) Cycles 1-4 (1 cycle = Q2W or Q3W):\n\nNivolumab Placebo Q3W + AC Q3W or Nivolumab Placebo Q2W + AC Q2W\n\nSurgery and Adjuvant (Post-surgery) Phase 7 cycles maximum:\n\nAdjuvant Cycles 1-7 (1 cycle = Q4W):\n\nEndocrine Therapy (ET)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.9', 'spread': '12.0', 'groupId': 'BG000'}, {'value': '50.9', 'spread': '11.8', 'groupId': 'BG001'}, {'value': '50.4', 'spread': '11.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '262', 'groupId': 'BG000'}, {'value': '257', 'groupId': 'BG001'}, {'value': '519', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '202', 'groupId': 'BG000'}, {'value': '193', 'groupId': 'BG001'}, {'value': '395', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-27', 'size': 9208125, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-01-12T15:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 521}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT02475382', 'statusForNctId': 'NO_LONGER_AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-16', 'studyFirstSubmitDate': '2019-09-27', 'resultsFirstSubmitDate': '2024-01-12', 'studyFirstSubmitQcDate': '2019-09-27', 'lastUpdatePostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-13', 'studyFirstPostDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pathological Complete Response (pCR) Rate', 'timeFrame': 'Up to approximately 37 months', 'description': 'pCR rate is defined as the percentage of participants who achieved pCR. pCR is defined as no invasive residual disease in breast and lymph nodes performed by a local pathologist. Criteria for evaluation of pCR includes the following: pCR in breast, axillary lymph nodes and non-axillary sentinel node; no histologic evidence of invasive tumor cells; and pCR in the breast.'}], 'secondaryOutcomes': [{'measure': 'Pathological Complete Response (pCR) Rate (PD-L1 >=1%)', 'timeFrame': 'Up to approximately 37 months', 'description': 'pCR rate is defined as the percentage of participants who achieved pCR. pCR is defined as no invasive residual disease in breast and lymph nodes performed by a local pathologist. Criteria for evaluation of pCR includes the following: pCR in breast, axillary lymph nodes and non-axillary sentinel node; no histologic evidence of invasive tumor cells; and pCR in the breast.'}, {'measure': 'Number of Participants With Residual Cancer Burden (RCB)', 'timeFrame': 'Up to approximately 37 months', 'description': 'RCB is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. RCB is categorized into the following 4 classes: RCB-0: no residual disease; RCB-1: minimal residual disease; RCB-II: moderate residual disease; RCB-III: and extensive residual disease.'}, {'measure': 'Number of Participants With Residual Cancer Burden (RCB) PD-L1 >=1%', 'timeFrame': 'Up to approximately 37 months', 'description': 'RCB is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. RCB is categorized into the following 4 classes: RCB-0: no residual disease; RCB-1: minimal residual disease; RCB-II: moderate residual disease; RCB-III: and extensive residual disease.'}, {'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'From first dose to 30 days post last dose of neoadjuvant or adjuvant study therapy (Up to approximately 19 months)', 'description': 'Number of participants with any grade adverse events (AEs). An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relation with this treatment. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs)', 'timeFrame': 'From first dose to 30 days post last dose of neoadjuvant or adjuvant study therapy (Up to approximately 19 months)', 'description': 'Number of participants with any grade serious adverse events (SAE). SAE is defined as any untoward medical occurrence that, at any dose: Results in death; is life threatening; requires inpatient hospitalization; results in persistent or significant disability; is a congenital anomaly/birth defect. Toxicities will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.'}, {'measure': 'Number of Participants Who Died', 'timeFrame': 'Up to approximately 41 months', 'description': 'Number of participants who died due to any cause.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nivolumab', 'Breast Cancer', 'Cancer', 'Estrogen Receptor-Positive (ER+)', 'Human Epidermal Growth Factor 2 Negative (HER2-)', 'Neoadjuvant', 'Adjuvant', 'Primary Breast Cancer'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '39838118', 'type': 'DERIVED', 'citation': 'Loi S, Salgado R, Curigliano G, Romero Diaz RI, Delaloge S, Rojas Garcia CI, Kok M, Saura C, Harbeck N, Mittendorf EA, Yardley DA, Suarez Zaizar A, Caminos FR, Ungureanu A, Reinoso-Toledo JG, Guarneri V, Egle D, Ades F, Pacius M, Chhibber A, Chandra R, Nathani R, Spires T, Wu JQ, Pusztai L, McArthur H. Neoadjuvant nivolumab and chemotherapy in early estrogen receptor-positive breast cancer: a randomized phase 3 trial. Nat Med. 2025 Feb;31(2):433-441. doi: 10.1038/s41591-024-03414-8. Epub 2025 Jan 21.'}, {'pmid': '38913933', 'type': 'DERIVED', 'citation': 'Schlam I, Corti C, Sammons S, Mittendorf EA, Tolaney SM. Checkpoint inhibition for early-stage hormone receptor-positive breast cancer. Expert Opin Biol Ther. 2024 Jun;24(6):511-520. doi: 10.1080/14712598.2024.2370395. Epub 2024 Jun 24.'}], 'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'http://www.BMSClinicalTrials.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'A randomized multi-arm study evaluating the efficacy and safety of nivolumab versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in participants with high-risk, estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) early stage breast cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Localized invasive breast ductal carcinoma, confirmed by the local pathologist, that includes the following combined primary tumor and clinical node (cN) categories: T1c (tumor size = 2 cm)-T2 (tumor size \\> 2 cm), cN1-N2 OR T3-T4, cN0-cN2. Note: Axillary lymph node status must be assessed by fine needle biopsy or core biopsy.\n* Estrogen receptor-positive (ER+) breast cancer (BC) and with or without progesterone receptor (PgR) expression (determined on the most recently analyzed tissue sample, tested locally, and confirmed by the central laboratory), as defined in the relevant American Society of Clinical Oncology (ASCO)- College of American Pathologists (CAP) Guidelines.\n* Human epidermal growth factor receptor 2 (HER2-) BC tested in the local laboratory, defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+, or 2+.\n* Tumor Grade 3 of ductal histology, Or Tumor Grade 2 of ductal histology having an ER expression level percentage between 1-10%\n* Must agree to provide primary breast tumor tissue at baseline and at surgery\n* Must be deemed eligible for surgery\n* Males and females must agree to follow specific methods of contraception, if applicable, while participating in the trial\n* Must have an Eastern Cooperative Oncology Group (ECOG) scale performance status of 0 or 1\n\nExclusion Criteria:\n\n* Breastfeeding, pregnant, or expecting to conceive or father children within the projected duration of the study, starting with the screening through 12 months for participants who receive cyclophosphamide, or 6 months for participants who do not receive cyclophosphamide, after the last dose of study treatment\n* Prior treatment with chemotherapy, endocrine therapy (ET), targeted therapy, and/or radiation therapy for the currently diagnosed breast cancer prior to enrollment\n* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways\n* Significant cardiovascular disease such as left ventricular ejection fraction (LVEF) \\< 50% at baseline as assessed by echocardiography (ECHO) or multigated acquisition (MUGA) scan performed at screening, or Class III or IV myocardial disease as described by the New York Heart Association\n* History of ipsilateral invasive BC, regardless of treatment, ipsilateral ductal carcinoma in situ treated with radiation, or contralateral invasive BC, at any time\n* Definitive clinical or radiologic evidence of metastatic disease\n* Multicentric BC (the presence of \\> 1 tumor in different quadrants of the breast)\n* Bilateral invasive BC\n\nOther protocol-defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT04109066', 'acronym': 'CheckMate 7FL', 'briefTitle': 'Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Randomized, Multicenter, Double-blind, Placebo-controlled Phase 3 Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Patients With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast Cancer', 'orgStudyIdInfo': {'id': 'CA209-7FL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: Nivolumab combined with neoadjuvant CT and adjuvant ET', 'description': "Nivolumab with paclitaxel followed by nivolumab with anthracycline + cyclophosphamide as neoadjuvant (pre-surgery) treatment, then nivolumab with adjuvant (post-surgery) endocrine therapy of investigator's choice", 'interventionNames': ['Biological: nivolumab', 'Drug: paclitaxel (PTX)', 'Drug: anthracycline', 'Drug: cyclophosphamide', 'Drug: Endocrine Therapy', 'Procedure: Surgery']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm B: Placebo combined with neoadjuvant CT and then adjuvant ET', 'description': "Nivolumab 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