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

West German Study Group2 sites in 1 country4,936 target enrollmentMay 2012

ConditionsBreast Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: West German Study Group
Enrollment: 4936
Locations: 2
Primary Endpoint: Identification of a responder sub-population with intermediate and high risk, which due to therapy has outcome comparable to HR+/RS≤11
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2012

End Date

January 15, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

West German Study Group

Responsible Party

Sponsor

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 \<= 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

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

Outcomes

Primary Outcomes

Identification of a responder sub-population with intermediate and high risk, which due to therapy has outcome comparable to HR+/RS≤11

Time Frame: 8 years

In order to identify patients that are at comparable low risk as hormone receptor positive, HER2 negative patients with low Recurrence Score, any sub-population across the sub-trials will be compared to this risk group.