Novel Biomarker-Driven Therapies for Breast Cancer

(EVOLVE-BDT Trial)

Overseen By Ana Gallegos

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: Inaccessible lesion, 2nd line therapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Until progression, toxicity, or physician discretion

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Lisa A Carey, MD

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Eric Winer, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with metastatic breast cancer that's either estrogen receptor-positive/hormone receptor-negative or triple-negative. They must be able to follow the study plan and have an ECOG performance status of 0-2, meaning they can care for themselves and are up and about more than half of the day.

Inclusion Criteria

I have signed the consent form and agreed to share my health information for the study.

I am willing and able to follow the study's requirements.

I am 18 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive biomarker-directed therapies based on their subtype, with liquid biopsy collected on Cycle 2 Day 1 and at each re-staging

Until progression, toxicity, or physician discretion

Regular visits for treatment and re-staging assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 12 months

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Antiandrogen
• Capecitabine
• SERD* + abemaciclib
• SERD* + everolimus
• SERD* + everolimus or capecitabine

Trial Overview

The trial tests different combinations of drugs (SERD* with abemaciclib, everolimus, capecitabine) against standard treatments based on tumor biomarkers in patients. It includes collecting data from past treatments, current medical records, tumor tissue samples, and blood tests before starting treatment.

How Is the Trial Designed?

Group I: Cohort 4 Experimental Treatment 1 Intervention

Triple-Negative Breast Cancer (TNBC): ER- (Estrogen receptor negative), PR- (Progesterone receptor negative), HER2- HER2 negative. AR + = Androgen Receptor positive, PD-L1 (Programmed Death-Ligand 1) positive or negative.

Group II: Cohort 2 Arm B Experimental Treatment 1 Intervention

ER+ (Estrogen Receptor Positive) and HER2- (Human Epidermal Growth Factor Receptor 2 Negative). ESR1 mutant negative or positive, and Phosphatidylinositol 3-kinase catalytic subunit alpha / AKT serine/threonine kinase / PTEN loss or deletion positive.

Group III: Cohort 2 Arm A Experimental Treatment 1 Intervention

ER+ (Estrogen Receptor Positive) and HER2- (Human Epidermal Growth Factor Receptor 2 Negative). ESR1 mutant negative or positive, and Phosphatidylinositol 3-kinase catalytic subunit alpha / AKT serine/threonine kinase / PTEN loss or deletion positive.

Group IV: Cohort 1- Arm B Experimental Treatment 1 Intervention

ER+ (Estrogen Receptor Positive) and HER2- (Human Epidermal Growth Factor Receptor 2 Negative). ESR1 mutant positive or negative and Phosphatidylinositol 3-kinase catalytic subunit alpha / AKT serine/threonine kinase / PTEN loss or deletion negative.

Group V: Cohort 1 Arm A Experimental Treatment 1 Intervention

ER+ (Estrogen Receptor Positive) and HER2- (Human Epidermal Growth Factor Receptor 2 Negative). ESR1 mutant positive or negative and Phosphatidylinositol 3-kinase catalytic subunit alpha / AKT serine/threonine kinase / PTEN loss or deletion negative.

Group VI: Cohort 3 Active Control 1 Intervention

Triple-Negative Breast Cancer (TNBC): ER- (Estrogen receptor negative), PR- (Progesterone receptor negative), HER2- HER2 negative. AR - = Androgen Receptor negative, PD-L1 (Programmed Death-Ligand 1) positive or negative.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

Breast Cancer Research Foundation

Collaborator

Trials

79

Recruited

40,500+

Translational Breast Cancer Research Consortium

Collaborator

Trials

27

Recruited

3,100+

Advanced Research Projects Agency for Health (ARPA-H)

Collaborator