Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT07340541
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SERD* + abemaciclib — DRUG
    Investigators choice Selective Estrogen Receptor Degrader + abemaciclib therapy.
  • SERD* + everolimus — DRUG
    Investigators choice Selective Estrogen Receptor Degrader + everolimus therapy.
  • SERD* + everolimus or capecitabine — DRUG
    Investigators choice Selective Estrogen Receptor Degrader + everolimus or capecitabine therapy.
  • SOC — DRUG
    standard-of-care (SOC) chemotherapy in breast cancer
  • Antiandrogen — DRUG
    Antiandrogen therapy

Study Details

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.

Key Dates

Start date
Feb 16, 2026
Status verified
May 2026
Primary completion
Jun 2, 2031
Completion
Jun 2, 2031

Study Design

Enrollment
700 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 Arm A
    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.
  • Experimental: Cohort 1- Arm B
    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.
  • Experimental: Cohort 2 Arm A
    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.
  • Experimental: Cohort 2 Arm B
    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.
  • Active Comparator: Cohort 3
    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.
  • Experimental: Cohort 4
    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.

Primary Outcome Measure

Intra-Individual Progression-Free Survival (PFS) [ Time Frame: Up to 5 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905
Karthik Giridhar, MD (PRINCIPAL_INVESTIGATOR)
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel HillNorth Carolina27599-7305
Lisa A. Carey, MD
919-966-4431
Lisa A Carey, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Rochester, MN

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Mayo Clinic· Rochester, MNLineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill· Chapel Hill, NC

Related Studies