Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2026-01-13 @ 12:44 PM
Study NCT ID:
NCT02846428
Status:
COMPLETED
Last Update Posted:
2016-07-27
First Post:
2016-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Efficacy and Safety of Capecitabine Prior to Surgery in Women With Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D015251', 'term': 'Epirubicin'}], 'ancestors': [{'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 182}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-25', 'studyFirstSubmitDate': '2016-07-25', 'studyFirstSubmitQcDate': '2016-07-25', 'lastUpdatePostDateStruct': {'date': '2016-07-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants with pathological complete tumor response Assessed by Expert Blinded Independent Review according to the Sataloff classification\\n', 'timeFrame': 'Day 120 +/- 7 days'}], 'secondaryOutcomes': [{'measure': 'Percentage of participants with pathological complete tumor response Assessed by Investigator according to the Sataloff classification', 'timeFrame': 'Day 120 +/- 7 days'}, {'measure': 'Percentage of participants with breast conserving surgery', 'timeFrame': 'Day 120 +/- 7 days'}, {'measure': 'Percentage of participants with objective clinical response, assessed by World Health Organization (WHO) criteria', 'timeFrame': 'Week 15'}, {'measure': 'Percentage of participants with clinical response, assessed by WHO criteria', 'timeFrame': 'Week 15'}, {'measure': 'Percentage of participants with disease progression, assessed by WHO criteria', 'timeFrame': 'Baseline up to 29 +/- 1 weeks'}, {'measure': 'Percentage of participants with abnormalities in bilateral mammography', 'timeFrame': 'Day 85'}, {'measure': 'Percentage of participants who died', 'timeFrame': 'Baseline up to 29 +/- 1 weeks'}, {'measure': 'Percentage of participants with abnormal left ventricular ejection fraction (LVEF)', 'timeFrame': 'Days 1-85'}, {'measure': 'Percentage of participants with abnormal liver ultrasound', 'timeFrame': 'Days 1-85'}, {'measure': 'Percentage of participants with abnormal Chest X-Ray', 'timeFrame': 'Days 1-85'}, {'measure': 'Overall survival', 'timeFrame': 'Baseline up to 5 years'}, {'measure': 'Disease free survival, according to WHO criteria', 'timeFrame': 'Baseline up to 5 years'}]}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and safety of treatment with oral capecitabine or intravenous (IV) 5-fluorouracil (5-FU), in combination with epirubicin and cyclophosphamide, prior to surgery in participants with breast cancer. The participants will receive 4 cycles of neoadjuvant Capecitabine + Epirubicin + Cyclophosphamide (CEX) or 5-FU + Epirubicin + Cyclophosphamide (FEC 100) chemotherapy during first treatment period (Period 1, Days 1-85). After 4-6 weeks of the fourth cycle of neoadjuvant chemotherapy (Day 120 +/- 7 days), breast surgery with regional lymph node dissection will be performed, followed within a maximum of 6 weeks by the second treatment period (Period 2, Days 1 to 85) when participants in both study arms will receive 4 cycles of adjuvant docetaxel 100 milligrams per meter square (mg/m\\^2) by IV infusion on Day 1 of each 21-day cycle. Upon completion of the second treatment period, participants will enter the post-treatment follow-up period which will last for 5 years from the initial date of participant randomization. During this period participants will be evaluated once a year on the anniversary date of randomization.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Females with a unilateral, non-inflammatory, non-multicentric, non-metastatic breast adenocarcinoma, not considered candidates for conservative management, and whose diagnosis had been histologically confirmed as T2-3, N0-1, M0 according to the tumor-nodes-metastasis (TNM) classification\n* Clinically or radiologically measurable lesion (in 2 dimensions)\n* Eastern Cooperative Oncology Group (ECOG) performance Status less than equal to (\\<=) 1\n\nExclusion Criteria:\n\n* Females presenting with brain metastases or a neurological or psychiatric disorder which could interfere with proper treatment compliance\n* Previous radiotherapy, chemotherapy, or hormonal therapy for breast cancer\n* Previous history of a malignancy in last 5 years other than cutaneous basal cell carcinoma or carcinoma in situ of the uterine cervix\n* Serious concomitant infection\n* Pregnant or lactating females'}, 'identificationModule': {'nctId': 'NCT02846428', 'briefTitle': 'To Evaluate the Efficacy and Safety of Capecitabine Prior to Surgery in Women With Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'An Open-Label, Multicenter, Randomized, Phase II Study to Evaluate the Efficacy and Safety of Two Combination Dose Regimens: Capecitabine + Epirubicin + Cyclophosphamide (CEX) Versus 5-FU + Epirubicin + Cyclophosphamide (FEC 100) as Neoadjuvant Therapy in Females Presenting With Operable Breast Cancer', 'orgStudyIdInfo': {'id': 'ML16986'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '5-Fluorouracil + Epirubicin + Cyclophosphamide', 'description': 'Neoadjuvant treatment (Period 1): Participants will receive 4 cycles (cycle length = 21 days) of 5-FU + epirubicin + cyclophosphamide. Surgery will be performed 5 (+/- 1) weeks after the last cycle. Adjuvant treatment (Period 2): Participants will receive 4 cycles (cycle length = 21 days) of docetaxel.', 'interventionNames': ['Drug: 5-Fluorouracil', 'Drug: Cyclophosphamide', 'Drug: Docetaxel', 'Drug: Epirubicin']}, {'type': 'EXPERIMENTAL', 'label': 'Capecitabine + Epirubicin + Cyclophosphamide', 'description': 'Neoadjuvant treatment (Period 1): Participants will receive 4 cycles (cycle length = 21 days) of capecitabine + epirubicin + cyclophosphamide. Surgery will be performed 5 (+/- 1) weeks after the last cycle. Adjuvant treatment (Period 2): Participants will receive 4 cycles (cycle length = 21 days) of docetaxel.', 'interventionNames': ['Drug: Capecitabine', 'Drug: Cyclophosphamide', 'Drug: Docetaxel', 'Drug: Epirubicin']}], 'interventions': [{'name': '5-Fluorouracil', 'type': 'DRUG', 'description': '5-FU will be administered at 500 mg/m\\^2 by short IV infusion on Day 1 of each 21-day cycle during neoadjuvant treatment period for 4 cycles.', 'armGroupLabels': ['5-Fluorouracil + Epirubicin + Cyclophosphamide']}, {'name': 'Capecitabine', 'type': 'DRUG', 'otherNames': ['Xeloda'], 'description': 'Capecitabine will be administered at 900 mg/m\\^2 orally twice daily on Days 1-14 of each 21-day cycle for 4 cycles during neoadjuvant treatment period.', 'armGroupLabels': ['Capecitabine + Epirubicin + Cyclophosphamide']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'Cyclophosphamide will be administered at 500 mg/m\\^2 by short IV infusion on Day 1 of each 21-day cycle for 4 cycles during neoadjuvant treatment period.', 'armGroupLabels': ['5-Fluorouracil + Epirubicin + Cyclophosphamide', 'Capecitabine + Epirubicin + Cyclophosphamide']}, {'name': 'Docetaxel', 'type': 'DRUG', 'description': 'Docetaxel will be administered at 100 mg/m\\^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles during adjuvant treatment period.', 'armGroupLabels': ['5-Fluorouracil + Epirubicin + Cyclophosphamide', 'Capecitabine + Epirubicin + Cyclophosphamide']}, {'name': 'Epirubicin', 'type': 'DRUG', 'description': 'Epirubicin will be administered at 100 mg/m\\^2 by short IV infusion on Day 1 of each 21-day cycle for 4 cycles during neoadjuvant treatment period.', 'armGroupLabels': ['5-Fluorouracil + Epirubicin + Cyclophosphamide', 'Capecitabine + Epirubicin + Cyclophosphamide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64100', 'city': 'Bayonne', 'country': 'France', 'geoPoint': {'lat': 43.49316, 'lon': -1.473}}, {'zip': '34500', 'city': 'Béziers', 'country': 'France', 'geoPoint': {'lat': 43.34122, 'lon': 3.21402}}, {'zip': '01012', 'city': 'Bourg-en-Bresse', 'country': 'France', 'geoPoint': {'lat': 46.20574, 'lon': 5.2258}}, {'zip': '68024', 'city': 'Colmar', 'country': 'France', 'geoPoint': {'lat': 48.08078, 'lon': 7.35584}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '83400', 'city': 'Hyères', 'country': 'France', 'geoPoint': {'lat': 43.12038, 'lon': 6.12857}}, {'zip': '38700', 'city': 'La Tronche', 'country': 'France', 'geoPoint': {'lat': 45.20507, 'lon': 5.74629}}, {'zip': '72037', 'city': 'Le Mans', 'country': 'France', 'geoPoint': {'lat': 48.0021, 'lon': 0.20251}}, {'zip': '87042', 'city': 'Limoges', 'country': 'France', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'zip': '69437', 'city': 'Lyon', 'country': 'France', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13385', 'city': 'Marseille', 'country': 'France', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '25209', 'city': 'Montbéliard', 'country': 'France', 'geoPoint': {'lat': 47.50957, 'lon': 6.79823}}, {'zip': '93370', 'city': 'Montfermeil', 'country': 'France', 'geoPoint': {'lat': 48.8982, 'lon': 2.57913}}, {'zip': '06189', 'city': 'Nice', 'country': 'France', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '75181', 'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '69310', 'city': 'Pierre-Bénite', 'country': 'France', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '44805', 'city': 'Saint-Herblain', 'country': 'France', 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'zip': '67010', 'city': 'Strasbourg', 'country': 'France', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '56001', 'city': 'Vannes', 'country': 'France', 'geoPoint': {'lat': 47.65688, 'lon': -2.76205}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_CHAIR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}