NCT05693766

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Sonya Reid · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Invasive Mammary Carcinoma
• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Capecitabine	2000 mg taken by mouth twice daily for 7 days on, 7 days off
OTHER	Endocrine-therapy	Endocrine therapy administered
OTHER	MammoPrint ® and BluePrint assays	Archival tissue will be analyzed using the MammoPrint ® and BluePrint assays

Timeline

• Start date: 2023-09-28
• Primary completion: 2027-08-31
• Completion: 2037-08-31
• First posted: 2023-01-23
• Last updated: 2026-01-20

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study