Integrating Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort (INSIGHT)
Sonya Reid
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)
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-…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Signed and dated written informed consent. * Subjects ≥ 18 years of age. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. * Clinical stage IV invasive mammary carcinoma or unresectable locoregional recurrence of invasive mammary carcinoma that is: * ER (\>/=1%) and/or PR (\>/= 1%) by IHC and HER2 negative (by IHC or FISH) * Previously exposed to an aromatase inhibitor (AI) or a selective estrogenreceptor modulator/ downregulator (SERM; SERD) + a CDK4/6 inhibitor. * Prior radiation permitted (if completed at least 2 weeks prior to study entry. Pat…
Interventions
- DrugCapecitabine
2000 mg taken by mouth twice daily for 7 days on, 7 days off
- OtherEndocrine-therapy
Endocrine therapy administered
- OtherMammoPrint ® and BluePrint assays
Archival tissue will be analyzed using the MammoPrint ® and BluePrint assays
Locations (3)
- University of Alabama BirminghamBirmingham, Alabama
- Vanderbilt University/Ingram Cancer CenterNashville, Tennessee
- UT Southwestern Medical CenterDallas, Texas