Evaluating chemotherapy versus endocrine therapy for hormone receptor-positive metastatic breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, multicenter Phase II clinical trial aims to assess the effectiveness of second-line chemotherapy using capecitabine compared to an endocrine therapy-based regimen in patients with non-Luminal A hormone receptor-positive metastatic breast cancer. The primary objective is to determine the anti-tumor effects of these two treatment approaches. Additionally, the study will evaluate the safety and tolerability of capecitabine and explore the potential of tumor mutations in cfDNA as early indicators of treatment response and resistance. The trial will involve patients who have previously been treated with specific hormone therapies.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Alabama Birmingham
  Birmingham, Alabama, United States Recruiting
• West Cancer Center (Margaret West Comprehensive Breast Center)
  Memphis, Tennessee, United States Recruiting
• Vanderbilt University/Ingram Cancer Center
  Nashville, Tennessee, United States Recruiting
• UT Southwestern Medical Center
  Dallas, Texas, United States Recruiting

Study contacts

• Principal investigator: Sonya Reid, MD — Vanderbilt University/Ingram Cancer Center
• Study coordinator: Vanderbilt-Ingram Services for Timely Access
• Email: cip@vumc.org
• Phone: 800-811-8480

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.