Adaptive biomarker-driven therapies for metastatic breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multi-arm, biomarker-stratified platform enrolls patients with ER+/HER2- or triple-negative metastatic breast cancer who have progressed on first-line therapy and are about to start second-line treatment. The design uses both archival tumor tissue and prospective tumor and blood sampling, with liquid biopsies collected before treatment and at each re-staging visit. Patients are assigned to biomarker-directed treatment arms (including combinations with SERDs, CDK4/6 inhibitors, mTOR inhibitors, capecitabine, or antiandrogens) and may be reassigned to other eligible subtrials upon progression. The primary endpoint for each arm is progression-free survival, and the adaptive framework is intended to accelerate learning and the evaluation of multiple targeted approaches simultaneously.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
* Subject is willing and able to comply with study procedures based on the judgement of the investigator.
* Age ≥ 18 years of age at the time of consent
* ECOG Performance Status of 0-2 (see APPENDIX A: ECOG Performance Status Scale).
* Patients must fulfill all eligibility criteria outlined in the LCCC2521 Parent Protocol and consented to LCCC2521 Parent Protocol

Exclusion Criteria:

* Inaccessible metastatic lesion to research biopsy
* Subject has already initiated 2nd line therapy
* Concurrent disease or condition that in the opinion of the treating oncologist renders the patient inappropriate for study participation

Where it's running

• Yale Cancer Center Clinical Trials Office
  New Haven, Connecticut, United States Recruiting
• Johns Hopkins University/Sidney Kimmel Cancer Center
  Baltimore, Maryland, United States Recruiting
• Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  Chapel Hill, North Carolina, United States Recruiting
• University of Pennsylvania/Abramson Cancer Center
  Philadelphia, Pennsylvania, United States Recruiting
• Mayo Clinic
  Rochester, Minnesota, United States Not yet recruiting
• Baylor College of Medicine
  Houston, Texas, United States Not yet recruiting

Study contacts

• Principal investigator: Lisa A Carey, MD — UNC Lineberger Comprehensive Cancer Center
• Study coordinator: Emily L Schworer
• Email: emily_lane@med.unc.edu
• Phone: 919-984-0000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.