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

Recruiting now · Phase 2

Conditions studied: Invasive Mammary Carcinoma, Metastatic Breast Cancer

In brief

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 facts

Study ID

NCT05693766

Run by

Sonya Reid

People needed

64

Starts

2023-09-28

Expected to finish

2037-08-31

Last updated by the study team

2026-01-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Alabama Birmingham — Birmingham, Alabama, United States (enrolling)
• Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee, United States (enrolling)
• UT Southwestern Medical Center — Dallas, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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