Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer
Inclusion Criteria:
- Female patients, age at diagnosis 18 - 75 years
- 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
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 or 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
interventional clinical trial with or without 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
- Patients not able to consent