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

• Status: Not yet recruiting
• Trial end date: 2037-04-30
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sonya Reid
• Collaborators: Agendia; Susan G. Komen Breast Cancer Foundation
• Treatments: Capecitabine

Criteria

Inclusion Criteria:

• 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/PR-positive (> 1% cells) 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

• Appropriate candidates for chemotherapy

• Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria that has not been previously irradiated and which can be followed by CT or MRI.

• Adequate organ function including:

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

• Platelets ≥ 100 × 10^9/L

• Hemoglobin ≥ 9/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 ≥ 50 mL/min as calculated using the Cockcroft-Gault (CG) equation

Exclusion Criteria:

• Prior chemotherapy in the metastatic setting

• More than 1 line of prior endocrine therapy in the metastatic setting

• Radiation therapy ≤ 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)

• Previous malignant disease other than breast cancer within the last 5 years, 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).

• Symptomatic brain metastases (patients with a history of brain metastases must be clinically stable for more than 4 weeks from completion of radiation treatment and off steroids)

• Persisting toxicity 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, alopecia and sensory neuropathy Grade ≤ 2 is acceptable.

• Pregnant or breastfeeding females.