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RecruitingPhase 2

Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies

TBCRC Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies (EVOLVE-BDT)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Liquid biopsy will be collected on Cycle 2 Day 1, and then liquid biopsy, imaging and clinical data will be collected at each re-staging."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

This is a multicenter, multi-arm, biomarker-stratified trial designed to evaluate biomarker-directed therapies in patients with estrogen receptor-positive/hormone receptor-negative (ER+/HR-) and triple-negative (TN) metastatic breast cancer (MBC). The trial integrates both retrospective and prospective data collection, including archival tumor tissue, medical record abstraction, and prospective tumor and blood sampling prior to initiation of protocol directed treatment. Based on biomarker subtype, participants will receive standard of care therapy. Liquid biopsy will be collected on Cycle 2 Day 1, and then liquid biopsy, imaging and clinical data will be collected at each re-staging. Treatment will continue until discontinuation for progression, toxicity or at the discretion of the treating physician.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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

Study sites (6)

CT

MD

  • Johns Hopkins University/Sidney Kimmel Cancer Center · Baltimore, MD 21287Cesar Santa-Maria, MD · Study contact · jhcccro@jhmi.eduCesar Santa-Maria, MD · Principal investigatorMore trials in Baltimore

MN

NC

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill · Chapel Hill, NC 27599-7305Lisa A. Carey, MD · Study contact · 919-966-4431Lisa A Carey, MD · Principal investigatorMore trials in Chapel Hill

PA

TX

  • Baylor College of Medicine · Houston, TX 77030Ahmed M Elkhanany, MD · Study contact · 713-798-1630Ahmed M Elkhanany, MD · Principal investigatorMore trials in Houston