Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer (ADAPT)

West German Study Group

Status and phase

Completed

Phase 3

Phase 2

Conditions

Breast Cancer

Treatments

Other: Induction therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01781338

WSG-AM06 / ADAPT

Details and patient eligibility

About

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.

Enrollment

4,936 estimated patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

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