Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-03 @ 5:57 PM
Study NCT ID:
NCT02040935
Status:
COMPLETED
Last Update Posted:
2019-08-22
First Post:
2014-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of SC Administration of Trastuzumab (Herceptin) by SID at Home in HER2-Positive EBC Participants
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': 'D000068878', 'term': 'Trastuzumab'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-21', 'studyFirstSubmitDate': '2014-01-15', 'studyFirstSubmitQcDate': '2014-01-17', 'lastUpdatePostDateStruct': {'date': '2019-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)', 'timeFrame': 'From Baseline up to approximately 4 years'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics: Trough Concentrations (Ctrough) of Trastuzumab', 'timeFrame': 'Pre-dose (within 1 day before trastuzumab administration) at Cycles 2, 3, 9, and 10, 12 or 13 (cycle length=21 days)'}, {'measure': 'Health Survey Short Form-36 (SF-36) Score', 'timeFrame': 'Cycles 3 and 9 (cycle length=21 days)'}, {'measure': 'Mood and Anxiety Questionnaire (MASQ) Score', 'timeFrame': 'Cycles 3 and 9 (cycle length=21 days)'}, {'measure': 'Percentage of Participants Choosing to Return to Hospital Administration', 'timeFrame': 'Cycle 6 (cycle length=21 days)'}]}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This single-arm, open-label, local multicenter study will evaluate the safety and tolerability of trastuzumab administered subcutaneously (SC) by a single-use injection device (SID) in participants with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (EBC), following surgery and chemotherapy (neo-adjuvant or adjuvant).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast\n* HER2-positive disease\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Hormonal therapy will be allowed as per institutional guidelines\n* Prior use of anti-HER2 therapy will be allowed\n* Left ventricular ejection fraction (LVEF) greater than or equal to (\\>/=) 50 percent (%)\n* No evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy, or during concurrent chemotherapy (neo-adjuvant or adjuvant)\n* Use of concurrent radiotherapy will be permitted\n* Completion of surgery and chemotherapy (if applicable)\n\nExclusion Criteria:\n\n* History of other malignancy, except for participants with curatively treated carcinoma in situ of the cervix or basal cell carcinoma and participants with other curatively treated malignancies who have been disease-free for the last 5 years\n* Participants with severe dyspnea at rest or requiring supplementary oxygen therapy\n* Participants with other concurrent serious diseases that might interfere with planned treatment, including severe pulmonary conditions/illness\n* Serious cardiac illness or medical conditions that would preclude the use of trastuzumab, specifically: history of documented congestive heart failure, high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ECG), poorly controlled hypertension\n* Pregnant or lactating women\n* Women of childbearing potential and male participants with female partners of childbearing potential who are unable or unwilling to use adequate contraceptive methods during study treatment\n* Concurrent enrollment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, biphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment\n* Known hypersensitivity to trastuzumab, murine proteins, to any excipients of Herceptin, including hyaluronidase, or the adhesive of the SC device, or a history of severe allergic or immunological reactions, e.g. difficult to control asthma\n* Inadequate hepatic or renal function'}, 'identificationModule': {'nctId': 'NCT02040935', 'acronym': 'HOMERUS', 'briefTitle': 'A Study of SC Administration of Trastuzumab (Herceptin) by SID at Home in HER2-Positive EBC Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'HOMERUS: A Local, Open Label, Multicentre, Phase IIIB Study, Investigating Subcutaneous Trastuzumab Administered at Home With Single Injection Device in Patients With HER2-Positive Early Breast Cancer', 'orgStudyIdInfo': {'id': 'ML28878'}, 'secondaryIdInfos': [{'id': '2013-000829-31', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trastuzumab', 'description': 'Participants will receive 600 milligrams (mg) trastuzumab SC by SID every 3 weeks (Q3W) for up to a total of 1 year, unless disease recurrence, unacceptable toxicity or participant withdrawal occurs. The first 3 administrations will be done at hospital, after that participants will be permitted to self-administer under the supervision of a healthcare professional (HCP).', 'interventionNames': ['Drug: Trastuzumab']}], 'interventions': [{'name': 'Trastuzumab', 'type': 'DRUG', 'otherNames': ['Herceptin'], 'description': '600 mg SC Q3W by SID', 'armGroupLabels': ['Trastuzumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1815 JD', 'city': 'Alkmaar', 'country': 'Netherlands', 'facility': 'Medisch Centrum Alkmaar', 'geoPoint': {'lat': 52.63167, 'lon': 4.74861}}, {'zip': '3818 ES', 'city': 'Amersfoort', 'country': 'Netherlands', 'facility': 'Meander Medisch Centrum; Locatie Lichtenberg', 'geoPoint': {'lat': 52.155, 'lon': 5.3875}}, {'zip': '4819 EV', 'city': 'Breda', 'country': 'Netherlands', 'facility': 'Amphia ziekenhuis, locatie langendijk', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'zip': '2906 ZC', 'city': 'Capelle aan den IJssel', 'country': 'Netherlands', 'facility': 'IJsselland Ziekenhuis', 'geoPoint': {'lat': 51.92917, 'lon': 4.57778}}, {'zip': '2600 GA', 'city': 'Delft', 'country': 'Netherlands', 'facility': 'Reinier de Graaf Gasthuis; Oncology', 'geoPoint': {'lat': 52.00667, 'lon': 4.35556}}, {'zip': '6716 RP', 'city': 'Ede', 'country': 'Netherlands', 'facility': 'Ziekenhuis Gelderse Vallei; Inwendige Geneeskunde', 'geoPoint': {'lat': 52.03333, 'lon': 5.65833}}, {'zip': '9728 MG', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Martini Ziekenhuis', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '2035 RC', 'city': 'Haarlem', 'country': 'Netherlands', 'facility': 'Kennemer Gasthuis', 'geoPoint': {'lat': 52.38084, 'lon': 4.63683}}, {'zip': '7555 DL', 'city': 'Hengelo', 'country': 'Netherlands', 'facility': 'Ziekenhuisgroep Twente, Hengelo', 'geoPoint': {'lat': 52.26583, 'lon': 6.79306}}, {'zip': '1213 HX', 'city': 'Hilversum', 'country': 'Netherlands', 'facility': 'Tergooiziekenhuizen, loc. Hilversum', 'geoPoint': {'lat': 52.22333, 'lon': 5.17639}}, {'zip': '2134 TM', 'city': 'Hoofddorp', 'country': 'Netherlands', 'facility': 'Spaarne Ziekenhuis Haarlem; Oncologie', 'geoPoint': {'lat': 52.3025, 'lon': 4.68889}}, {'zip': '3430 EM', 'city': 'Nieuwegein', 'country': 'Netherlands', 'facility': 'St. Antonius Ziekenhuis Nieuwegein', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}, {'zip': '4708 AE', 'city': 'Roosendaal', 'country': 'Netherlands', 'facility': 'Franciscus Ziekenhuis', 'geoPoint': {'lat': 51.53083, 'lon': 4.46528}}, {'zip': '6162 BG', 'city': 'Sittard-Geleen', 'country': 'Netherlands', 'facility': 'Zuyderland ziekenhuis locatie Geleen'}, {'zip': '2504 LN', 'city': 'The Hague', 'country': 'Netherlands', 'facility': 'Haga Ziekenhuis', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'zip': '5912 BL', 'city': 'Venlo', 'country': 'Netherlands', 'facility': 'VieCuri - Medisch Centrum voor Noord-Limburg', 'geoPoint': {'lat': 51.37, 'lon': 6.16806}}, {'zip': '8011 JW', 'city': 'Zwolle', 'country': 'Netherlands', 'facility': 'Isala Klinieken', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}