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

March 23, 2023 updated by: West German Study Group
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

4936

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 81377
        • Breast Center of the University of Munich (LMU) Universitätsfrauenklinik Großhadern
    • NRW
      • Moenchengladbach, NRW, Germany, 41061
        • Ev. Krankenhaus Bethesda Brustzentrum Niederrhein

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Induction Therapy
The kind of induction therapy is dependent on the respective sub-protocol.
Other: Induction therapy
The intervention is dependent on the respective sub-protocol and can include either endocrine therapy, neoadjuvant chemotherapy or targeted therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 8 years
8 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Any pre-specified outcome measure is defined within the sub-protocols.
Time Frame: 8 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West German Study Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2012

Primary Completion (Actual)

September 1, 2020

Study Completion (Anticipated)

October 1, 2024

Study Registration Dates

First Submitted

January 25, 2013

First Submitted That Met QC Criteria

January 29, 2013

First Posted (Estimate)

February 1, 2013

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WSG-AM06 / ADAPT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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