adapt - adjuvant dynamic marker-adjusted personalized therapy trial optimizing risk assessment and therapy response prediction in early breast cancer

Conditions: Breast Cancer

Summary: trial for the optimization of risk assessment and therapy success prediction in patients with early breast cancer by the use of biomarkers in advance to therapy decision-making to personalize therapies.


Eligibility criteria:
inclusion criteria: * 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 \ = 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 x 10\^9/l * platelets \>= 100 x 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