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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01781338
Other study ID # WSG-AM06 / ADAPT
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date May 2012
Est. completion date October 2024

Study information

Verified date July 2019
Source West German Study Group
Contact Michael Staedele
Phone +49 2161 566 23
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility

Status Recruiting
Enrollment 4936
Est. completion date October 2024
Est. primary completion date April 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms


Induction therapy
The intervention is dependent on the respective sub-protocol and can include either endocrine therapy, neoadjuvant chemotherapy or targeted therapy.


Country Name City State
Germany Ev. Krankenhaus Bethesda Brustzentrum Niederrhein Moenchengladbach NRW
Germany Breast Center of the University of Munich (LMU) Universitätsfrauenklinik Großhadern Munich Bavaria

Sponsors (1)

Lead Sponsor Collaborator
West German Study Group

Country where clinical trial is conducted


References & Publications (1)

Hofmann D, Nitz U, Gluz O, Kates RE, Schinkoethe T, Staib P, Harbeck N. WSG ADAPT - adjuvant dynamic marker-adjusted personalized therapy trial optimizing risk assessment and therapy response prediction in early breast cancer: study protocol for a prospective, multi-center, controlled, non-blinded, randomized, investigator initiated phase II/III trial. Trials. 2013 Aug 19;14:261. doi: 10.1186/1745-6215-14-261. — View Citation


Type Measure Description Time frame Safety issue
Other Any pre-specified outcome measure is defined within the sub-protocols. Toxicity and cost efficacy are common endpoints of all sub-protocols. Additional "translational research" questions occurring during the trial will be defined in sub-protocols. 8 years
Primary Identification of a responder sub-population with intermediate and high risk, which due to therapy has outcome comparable to HR+/RS=11 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. 8 years
Secondary Overall survival 8 years
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