Gene Signatures to Guide HR+MBC Therapy

This study is for people with hormone receptor-positive (HR+) metastatic breast cancer (MBC) that is HER2 negative. It's looking at how well different treatments work for this type of cancer. You might receive capecitabine, a chemotherapy drug, or an endocrine therapy. Researchers will also analyze your tumor tissue using MammoPrint® and BluePrint assays to understand your cancer's gene signatures. The main goal is to see if one treatment helps you live longer without your cancer growing or spreading, measured over up to three years. The study is currently unclear about its recruitment status and plans to enroll 64 participants.

Study design: This is an open-label, multicenter Phase II study with two treatment arms. It plans to enroll 64 participants.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Your progress will be followed for up to three years to measure how long you live without your cancer growing.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting

PHASE2Ages 18+InterventionalTreatment

Sonya Reid

~64 participants

Updated 2026-01-20 on ClinicalTrials.gov

What's tested:CapecitabineEndocrine-therapyMammoPrint ® and BluePrint assays

At a glance

Recruiting sites

3 of 3 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Progression free survival

Measured over Up to 3 years

Conditions

Invasive Mammary Carcinoma

Metastatic Breast Cancer

Where it's being run

3 sites across 3 states

Alabama1

Tennessee1

Texas1

Study leadership

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

Who to contact

Vanderbilt-Ingram Services for Timely Access

[email protected]

800-811-8480

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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. Patients who have received prior radiotherapy must have recovered from toxicity (≤ grade 1) induced by this treatment (except for alopecia)

Patients with brain metastasis secondary to breast cancer and clinically stable for more than 4 weeks from completion of radiation treatment and off steroids

Evaluable disease (measurable or non-measurable)

Measurable disease, ie, at least 1 measurable lesion as per RECIST 1.1 (a lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation)

Patients with bone only disease allowed if possible to evaluate on radiological exams (eg.bone scan, PET/CT, CT, MRI) even if lesions are non-measurable according to RECIST1.1.

Adequate organ function including:

Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L

Platelets ≥ 100 × 10\^9/L

Hemoglobin ≥ 8/g/dL (may have been transfused)

Total serum bilirubin ≤ 1.5 times upper limit of normal (ULN)

Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 2.5 × ULN (or ≤ 5 × ULN if liver metastases are present)

Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 50mL/min as calculated using the Cockcroft-Gault (CG) equation

For randomized patients only: tumors must be diagnosed as non-Luminal A using the Blueprint® and Mammaprint® tests

Exclusion

Prior chemotherapy in the metastatic setting

Previous malignant disease other than breast cancer within the last 2 years with associated competing risk, with the exception of basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, or low-risk cancers considered curatively treated (i.e. complete remission achieved at least 2 years prior to first dose of study drugs AND additional therapy not required while receiving study treatment).

Persisting symptoms related to prior therapy that has not reduced to Grade 1 \[National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 5.0\]; however, menopausal symptoms, alopecia, and sensory neuropathy Grade ≤ 2 is acceptable

Pregnant or breastfeeding females.

What this trial measures

Progression free survivalUp to 3 years

Trialytics