Status:
COMPLETED
A Prospective, Randomized Multicenter, Open-label Comparison of Preoperative Combination of Trastuzumab and Pertuzumab With or Without Concurrent Taxane Chemotherapy Given for Twelve Weeks in Patients With Operable HER2+/HR- Breast Cancer Within the ADAPT Protocol
Lead Sponsor:
West German Study Group
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Trial to evaluate efficacy of dual blockade with two anti-HER2 agents with or without chemotherapy backbone within the ADAPT trial.
Eligibility Criteria
Inclusion
- Female patients, age at diagnosis 18 years and above (consider patients at 70 years and above for ADAPT Elderly)
- Histologically confirmed unilateral primary invasive carcinoma of the breast
- Clinical T1 - T4 (except inflammatory breast cancer)
- All clinical N (cN)
- No clinical evidence for distant metastasis (M0)
- Known HR status and HER2 status (local pathology) Tumor block available for central pathology review
- Performance Status ECOG ≤ 1 or KI ≥ 80%
- Negative pregnancy test (urine or serum) within 7 days prior to start of induction treatment in premenopausal patients
- Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements
- The patient must be accessible for treatment and follow-up
- Additional Inclusion criteria for participation in the HR-/HER2+ sub-protocol:
- Confirmed ER and PR negative and HER2+ by central pathology
- Clinical cT1c - T4a-c (participation of patients with tumors \>cT2 is strongly recommended)
- All clinical N (participation of patients with cN0, if at least cT1c is strongly recommended)
- Patients must qualify for neoadjuvant treatment
- LVEF \> 50%; LVEF within normal limits of each institution measured by echocardiography and normal ECG (within 42 days prior to induction treatment)
Exclusion
- Known hypersensitivity reaction to the compounds or incorporated substances
- Prior malignancy with a disease-free survival of \< 10 years, except curatively treated basalioma of the skin, pTis of the cervix uteri
- Non-operable breast cancer including inflammatory breast cancer
- Previous or concurrent treatment with cytotoxic agents for any reason after consultation with the sponsor
- Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry
- Male breast cancer
- Concurrent pregnancy; patients of childbearing potential must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment
- Breast feeding woman
- Sequential breast cancer
- Reasons indicating risk of poor compliance Patient not able to consent
- Additional Exclusion Criteria for participation in the HER2+/HR- sub-protocol:
- Known polyneuropathy ≥ grade 2
- Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study
- Inadequate organ function (e.g. hepatic impairment, pulmonary disease, etc.)
- Uncompensated cardiac function (current unstable ventricular arrhythmia requiring treatment, history of symptomatic CHF NYHA classes II-IV), history of myocardial infarction or unstable angina pectoris within 6 months of enrollment, history of severe hypertension, CAD - coronary artery disease)
- Severe dyspnea
- Abnormal blood values:
- Thrombocytopenia \> CTCAE grade 1
- Increases in ALT/AST \> CTCAE grade 1
- Hypokalaemia \> CTCAE grade 1
- Neutropenia \> CTCAE grade 1
- Anaemia \> CTCAE grade 1
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 15 2025
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT01817452
Start Date
March 1 2014
End Date
January 15 2025
Last Update
February 26 2025
Active Locations (1)
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1
Ev. Krankenhaus Bethesda Brustzentrum Niederrhien
Mönchengladbach, Germany, 41061