Actively Recruiting
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Led by Sonya Reid · Updated on 2026-01-20
64
Participants Needed
3
Research Sites
726 weeks
Total Duration
On this page
Sponsors
S
Sonya Reid
Lead Sponsor
A
Agendia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated written informed consent.
- Age 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Clinical stage IV invasive mammary carcinoma or unresectable locoregional recurrence that is estrogen receptor (ER) and/or progesterone receptor (PR) positive and HER2 negative.
- Prior treatment with an aromatase inhibitor or selective estrogen receptor modulator/downregulator plus CDK4/6 inhibitor.
- Prior radiation allowed if completed at least 2 weeks before study entry and toxicity recovered to grade 1 or less (except alopecia).
- Patients with brain metastasis stable for more than 4 weeks after radiation and off steroids.
- Presence of evaluable disease, including measurable lesions per RECIST 1.1 or bone-only disease evaluable by imaging.
- Adequate organ function as defined by specified blood count and chemistry thresholds.
- For randomized patients: tumors classified as non-Luminal A by MammoPrint® and BluePrint assays.
You will not qualify if you...
- Prior chemotherapy in the metastatic setting.
- Other malignant diseases within the last 2 years posing competing risk, except certain low-risk skin and cervical cancers treated curatively.
- Persistent symptoms from prior therapy worse than grade 1, except menopausal symptoms, alopecia, and sensory neuropathy of grade 2 or less.
- Pregnant or breastfeeding females.
AI-Screening
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Trial Site Locations
Total: 3 locations
1
University of Alabama Birmingham
Birmingham, Alabama, United States, 35249
Actively Recruiting
2
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
3
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
V
Vanderbilt-Ingram Services for Timely Access
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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