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

NCT01781338 | Completed Phase 2 DMC

• 1 other identifier: WSG-AM06 / ADAPT
• Study Type: interventional
• Target: 4,936
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Overall survival

  8 years

Other Outcomes (1)

• Any pre-specified outcome measure is defined within the sub-protocols.

  8 years

Study Arms (1)

Induction Therapy

EXPERIMENTAL

The kind of induction therapy is dependent on the respective sub-protocol.

Other: Induction therapy

Interventions

Induction therapy OTHER

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

Induction Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• West German Study Group: lead

Study Sites (2)

Breast Center of the University of Munich (LMU) Universitätsfrauenklinik Großhadern

Munich, Bavaria, 81377, Germany

Location

Ev. Krankenhaus Bethesda Brustzentrum Niederrhein

Mönchengladbach, North Rhine-Westphalia, 41061, Germany

Location

Related 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.

  PMID: 23958221 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Officials

• Nadia Harbeck, Prof. Dr.

  Breast Center of the University of Munich (LMU) Universitätsfrauenklinik Großhadern, Munich, Germany

  PRINCIPAL INVESTIGATOR

• Ulrike Nitz, Prof. Dr.

  Ev. Krankenhaus Bethesda Brustzentrum Niederrhein, Mönchengladbach, Germany

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2013
• First Posted: February 1, 2013
• Study Start: May 1, 2012
• Primary Completion: September 1, 2020
• Study Completion: January 15, 2025
• Last Updated: February 27, 2025

Record last verified: 2025-02

Locations

DE (2)