Breast CancerOpen to EnrollmentPhase 2

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

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

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Study snapshot

Title: Vanderbilt VICCBRE2256 HR+ MBC
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
Principal investigator: Sonia Benn, MD
Sponsor: Vanderbilt Cancer Center
Path: ER/PR+ HER2-
Randomized: Yes
ClinicalTrials.gov ID: NCT05693766

Eligibility and objectives

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

Primary
- PFS
Secondary
- OS at 2 years
- OS at 5 years
- OS at 10 years
- CBR
- ORR
- Safety

Treatment details