Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
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:
🦠 Invasive Mammary Carcinoma 🦠 Metastatic Breast Cancer
🗓️ Study Start (Actual) 11 September 2023
🗓️ Primary Completion (Estimated) 31 August 2027
✅ Study Completion (Estimated) 31 August 2037
👥 Enrollment (Estimated) 64
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Nashville, Tennessee, United States

📋 Eligibility Criteria

Description

    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 (\>/=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 Criteria:

    • * 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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 11 January 2023
  • First Submitted that Met QC Criteria 11 January 2023
  • First Posted 23 January 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 22 April 2024
  • Last Update Posted 23 April 2024
  • Last Verified April 2024