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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Sonya Reid
Study ID
NCT05693766
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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)

Key Dates

Start date
Sep 28, 2023
Status verified
Jan 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2037

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Physician's Choice of Endocrine-based Therapy_Non-Luminal A subtypes
  • Experimental: Capecitabine_Non-Luminal A subtypes

Primary Outcome Measure

Progression free survival [ Time Frame: Up to 3 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Alabama BirminghamBirminghamAlabama35249
Kyndall Thomas
Nusrat Jahan (PRINCIPAL_INVESTIGATOR)
Vanderbilt University/Ingram Cancer CenterNashvilleTennessee37232
Vanderbilt-Ingram Service for Timely Access
[email protected]
800-811-8480
Sonya Reid, MD (PRINCIPAL_INVESTIGATOR)
UT Southwestern Medical CenterDallasTexas75390
Vanderbilt-Ingram Services for Timely Access
800-811-8480
Heather McArthur, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Alabama Birmingham· Birmingham, ALVanderbilt University/Ingram Cancer Center· Nashville, TNUT Southwestern Medical Center· Dallas, TX

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