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BREAST: METASTATIC: HR+: NON-LUMINAL A: INSIGHT

Integrating Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort (INSIGHT)

Title

Vanderbilt VICCBRE2256 HR+ MBC

Study Title

Integrating Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort (INSIGHT)

Site Link

NCT05693766

Malignancy

Breast cancer, ER+ breast cancer, hormone receptor positive BC

Stage

Stage 4

Disease Setting

Metastatic/Unresectable

Line Of Therapy

1st line post endocrine therapy/CDK4/6 inhibitor

Investigational Agent

capecitabine

Drug Class

Cytotoxic chemotherapy

Sonia Benn, MD

Sponsor

Vanderbilt Cancer Center

Phase

Phase 2

Status

Open to Enrollment

Key Eligibility Criteria

Key Eligibility Criteria Details

Clinical Stage IV invasive mammary carcinoma or unresectable locoregional recurrnce of invasive mammary carcinoma
ER or PR positive (> or = 1%) and HER2 negative
Previously exposed to an AI or SERM plus a CDK4/6 inhibitor
No unstable brain mets
ECOG PS 0-1
Evaluable disease (measurable or unmeasurable)
Adequate organ function
For randomized patients must be diagnosed as non-Luminal A using Blueprint and Mammaprint tests
No prior chemo in metastatic setting
No previous malignant disease other than breast cancer within the last 2 years (except non-melanoma skin, cervical CIS, or low risk cancers considered curateively treated)

Objective

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

ER/PR+ HER2-

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes