Spots Global Cancer Trial Database for Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort

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Trial Identification

Brief Title: Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort

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

Study ID: NCT05693766

Conditions

Invasive Mammary Carcinoma

Metastatic Breast Cancer

Interventions

Capecitabine

Endocrine-therapy

MammoPrint ® and BluePrint assays

Study Description

Brief Summary: This is an open-label, multicenter, two-arm Phase II clinical trial that will evaluate the impact of 2nd line chemotherapy (i.e. capecitabine) on survival in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer (MBC)

Detailed Description: Primary Objective: - Determine the impact of early chemotherapy (i.e., capecitabine) versus endocrine therapy-based regimen on anti-tumor effect in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer Secondary Objectives: * Compare the safety and tolerability of capecitabine versus endocrine therapy in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer * Determine the impact of early chemotherapy (i.e., capecitabine) versus endocrine therapy-based regimen on anti-tumor effect in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer Correlatives: * Determine if the tumor mutations detected in cfDNA are early surrogates of response * Determine if the cfDNA results at disease progression show new genomic alterations potentially associated with resistance to therapy