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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by West German Study Group
Sponsor:
Information provided by (Responsible Party):
West German Study Group
ClinicalTrials.gov Identifier:
NCT01781338
First received: January 25, 2013
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Other: Induction therapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer

Resource links provided by NLM:


Further study details as provided by West German Study Group:

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 [ Time Frame: 8 years ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 8 years ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Any pre-specified outcome measure is defined within the sub-protocols. [ Time Frame: 8 years ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 4936
Study Start Date: May 2012
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01781338

Contacts
Contact: Daniel Hofmann, M. Sc. +49 2161 566 23 ext 17 daniel.hofmann@wsg-online.com
Contact: Sebastian Raeth, PhD +49 30 8862688 ext 13 sebastian.raeth@pallas-gmbh.com

Locations
Germany
Breast Center of the University of Munich (LMU) Universitätsfrauenklinik Großhadern Recruiting
Munich, Bavaria, Germany, 81377
Contact: Nadia Harbeck, Prof. Dr.         
Principal Investigator: Nadia Harbeck, Prof. Dr.         
Ev. Krankenhaus Bethesda Brustzentrum Niederrhein Recruiting
Moenchengladbach, NRW, Germany, 41061
Contact: Raquel von Schumann, MD         
Principal Investigator: Raquel von Schumann, MD         
Sponsors and Collaborators
West German Study Group
Investigators
Principal Investigator: Nadia Harbeck, Prof. Dr. Breast Center of the University of Munich (LMU) Universitätsfrauenklinik Großhadern, Munich, Germany
Study Chair: Ulrike Nitz, Prof. Dr. Ev. Krankenhaus Bethesda Brustzentrum Niederrhein, Mönchengladbach, Germany
  More Information

Publications:
Responsible Party: West German Study Group
ClinicalTrials.gov Identifier: NCT01781338     History of Changes
Other Study ID Numbers: WSG-AM06 / ADAPT
Study First Received: January 25, 2013
Last Updated: July 31, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014