Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer - Triple Negative Breast Cancer
Inclusion Criteria
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
Additional Inclusion Criteria for patients receiving chemotherapy:
- Laboratory requirements for patients receiving neoadjuvant chemotherapy (within 14
days prior to induction treatment):
- Leucocytes >= 3.5 10^9/L
- Platelets >= 100 10^9/L
- Hemoglobin >= 10 g/dL
- Total bilirubin <= 1 x ULN
- ASAT (SGOT) and ALAT (SGPT) <= 2.5 x UNL
- Creatinine <= 175 µmol/L (2 mg/dl)
- LVEF within normal limits of each institution measured by echocardiography and normal
ECG (within 42 days prior to induction treatment)
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
Additional Exclusion Criteria for patients receiving chemotherapy:
- Known polyneuropathy ≥ grade 2
- Severe and relevant co-morbidity that would interact with the application of
cytotoxic agents or the participation in the study including acute cystitis and
ischuria and chronic kidney disease
- Uncompensated cardiac function
- Inadequate organ function including:
- Leucocytes < 3.5 x 10^9/l
- Platelets < 100 x 10^9/l
- Bilirubin above normal limits
- Alkaline phosphatase > 5 x UNL
- ASAT and/or ALAT associated with AP > 2.5 x UNL