Breast Cancer
Conditions
Brief 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.
Interventions
DRUGEpirubicin
DRUGCyclophosphamide
DRUGDocetaxel
DRUGPaclitaxel
Sponsors
West German Study Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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 \<= 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identification of a responder sub-population with intermediate and high risk, which due to therapy has outcome comparable to HR+/RS≤11 | 3 Years |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | 3 Years |
Countries
Germany
Outcome results
None listed