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

Primary Purpose

Breast Cancer

Status
Active
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Induction therapy
Sponsored by
West German Study Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Breast Center of the University of Munich (LMU) Universitätsfrauenklinik Großhadern
  • Ev. Krankenhaus Bethesda Brustzentrum Niederrhein

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Induction Therapy

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall survival

Full Information

First Posted
January 25, 2013
Last Updated
March 23, 2023
Sponsor
West German Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT01781338
Brief Title
Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer
Acronym
ADAPT
Official Title
Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 2012 (Actual)
Primary Completion Date
September 2020 (Actual)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
West German Study Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4936 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Induction Therapy
Arm Type
Experimental
Arm Description
The kind of induction therapy is dependent on the respective sub-protocol.
Intervention Type
Other
Intervention Name(s)
Induction therapy
Intervention Description
The intervention is dependent on the respective sub-protocol and can include either endocrine therapy, neoadjuvant chemotherapy or targeted therapy.
Primary Outcome Measure Information:
Title
Identification of a responder sub-population with intermediate and high risk, which due to therapy has outcome comparable to HR+/RS≤11
Description
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.
Time Frame
8 years
Secondary Outcome Measure Information:
Title
Overall survival
Time Frame
8 years
Other Pre-specified Outcome Measures:
Title
Any pre-specified outcome measure is defined within the sub-protocols.
Description
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.
Time Frame
8 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadia Harbeck, Prof. Dr.
Organizational Affiliation
Breast Center of the University of Munich (LMU) Universitätsfrauenklinik Großhadern, Munich, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ulrike Nitz, Prof. Dr.
Organizational Affiliation
Ev. Krankenhaus Bethesda Brustzentrum Niederrhein, Mönchengladbach, Germany
Official's Role
Study Chair
Facility Information:
Facility Name
Breast Center of the University of Munich (LMU) Universitätsfrauenklinik Großhadern
City
Munich
State/Province
Bavaria
ZIP/Postal Code
81377
Country
Germany
Facility Name
Ev. Krankenhaus Bethesda Brustzentrum Niederrhein
City
Moenchengladbach
State/Province
NRW
ZIP/Postal Code
41061
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
23958221
Citation
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.
Results Reference
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Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer

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