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

NCT05693766 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-01-20

No results posted yet for this study

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)

Conditions

Interventions

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

Sponsors & Collaborators

  • Agendia

    collaborator INDUSTRY

  • Susan G. Komen Breast Cancer Foundation

    collaborator OTHER

  • Sonya Reid

    lead OTHER

Principal Investigators

  • Sonya Reid, MD · Vanderbilt University/Ingram Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-28
Primary Completion
2027-08-31
Completion
2037-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05693766 on ClinicalTrials.gov