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Evolutionary Clinical Trial for Metastatic Breast Cancer

This study is for adults with metastatic breast cancer, including triple-negative, ER-positive, or hormone receptor-negative types. It's testing several treatment approaches based on your specific tumor biomarkers (like HER2). You might receive a Selective Estrogen Receptor Degrader (SERD) combined with abemaciclib, everolimus, or everolimus/capecitabine. Other options include standard chemotherapy or antiandrogen therapy. The goal is to see if these treatments can stop your cancer from growing or spreading for as long as possible. The study plans to enroll 700 participants, but its current recruitment status is unclear.

Study design
This is a multi-center, multi-arm study designed to test several biomarker-driven therapies at once, with 700 planned participants.
What's involved
You will provide written informed consent and allow collection of archival tumor tissue, medical records, and prospective tumor and blood samples. Liquid biopsies, imaging, and clinical data will be collected at each re-staging.
Compensation
Not stated in the trial record.
Follow-up
Your progression-free survival will be measured for up to 5 years.

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NCT07340541

Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies

Recruiting
PHASE2Ages 18+InterventionalTreatment
UNC Lineberger Comprehensive Cancer Center
~700 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:SERD* + abemaciclibSERD* + everolimusSERD* + everolimus or capecitabineSOCAntiandrogen

At a glance

Recruiting sites
3 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Intra-Individual Progression-Free Survival (PFS)
Measured over Up to 5 years

Conditions

Breast Cancer
Metastatic Breast Cancer
Triple Negative Breast Cancer
Estrogen-receptor-positive Breast Cancer
Hormone Receptor Negative Breast Carcinoma

Explore related trials

Breast CarcinomaEstrogen Receptor-Positive Breast CarcinomaTriple-negative breast cancer

Where it's being run

4 sites across 4 states
Connecticut1
Maryland1
Minnesota1
North Carolina1

Study leadership

  • Lisa A Carey, MD · PRINCIPAL_INVESTIGATOR · UNC Lineberger Comprehensive Cancer Center
  • Eric Winer, MD · STUDY_CHAIR · Yale University

Who to contact

Emily L Schworer
[email protected]
919-984-0000
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Intra-Individual Progression-Free Survival (PFS)Up to 5 years

    Progression-Free Survival (PFS) is defined as the time from initiation of study therapy until documented disease progression per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1 or death from any cause, whichever occurs first. For intra-individual comparisons across successive therapy lines, a PFS ratio will be calculated by dividing the PFS of the current line (nth line, PFSₙ) by the PFS of the preceding line ((n-1)th line, PFSn-1). This allows each patient to serve as their own control, reducing between-patient variability and normalizing for the expected decline in PFS with later lines. RECIST v1.1 defines Complete Response (CR) as disappearance of all target lesions, Partial Response (PR) as ≥30% decrease, Stable Disease (SD) as insufficient change for PR or PD, and Progressive Disease (PD) as ≥20% increase, measurable growth in non-target lesions, or new lesions.