Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer (ADAPT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01781338|
Recruitment Status : Recruiting
First Posted : February 1, 2013
Last Update Posted : July 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Other: Induction therapy||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||4936 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer|
|Actual Study Start Date :||May 2012|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||October 2024|
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.
- 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.
- Overall survival [ Time Frame: 8 years ]
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01781338
|Contact: Michael Staedele||+49 2161 566 23 ext firstname.lastname@example.org|
|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|
|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|