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

Exclusion Criteria

• •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
• •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