Phase II Study of Low Dose Capecitabine for Older or Frail Patients with Advanced Breast Cancer

Sponsor: University of Alabama at Birmingham

Sponsor score: 0

ClinicalTrials ID:NCT06105684

Provider View

This study is testing a low dose of the drug capecitabine in patients aged 60 and older, or those who are frail, with advanced breast cancer. The goal is to see if this treatment is safe and effective for those who may not tolerate other treatments well.

Patient Parameters

Program Overview

This study is designed to evaluate the effects of a low dose of capecitabine, a chemotherapy drug, in patients with advanced breast cancer who are either 60 years or older, or considered frail at any age. These patients often face higher risks and poorer outcomes with standard treatments. The study will include 40 participants who have breast cancer that has spread or cannot be surgically removed, and who have already tried at least one other treatment. All participants will receive capecitabine at a dose of 1000 mg once daily. The study will stop if the cancer progresses or if there are unacceptable side effects.

Description

This clinical trial is a Phase II study where all participants will receive the same treatment. It focuses on older or frail patients with advanced breast cancer that has spread or cannot be removed by surgery. Participants will take a low dose of the chemotherapy drug capecitabine (1000 mg daily). The study aims to include 40 patients who have measurable cancer and have already tried at least one other treatment for their metastatic breast cancer. The types of breast cancer included are hormone receptor-positive (HR+) and triple-negative breast cancer (TNBC), and participants must be 60 years or older, or considered frail by their doctor. The study will continue until the cancer progresses or side effects become too severe.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with breast cancer that is HER2 negative, confirmed by specific lab tests.
  • Have advanced breast cancer that has spread or cannot be surgically removed, with at least one measurable tumor.
  • Have tried at least one previous treatment for metastatic breast cancer.
  • Be in relatively good health with an ECOG performance status of 0 to 2.
  • Have adequate organ function, including specific blood cell counts and liver and kidney function.
  • Be able to provide informed consent to participate in the study.
  • Female patients must be postmenopausal, surgically sterile, or using effective contraception. Male patients must agree to use contraception.
  • Be 60 years or older, or considered frail at any age due to health conditions.
  • Complete initial medical evaluations within two weeks before starting treatment.
  • HIV-positive patients can participate if they meet all other criteria.

Exclusion Criteria

  • Have previously been treated with capecitabine for metastatic breast cancer.
  • Have only non-measurable cancer.
  • Have severe liver or kidney problems.
  • Cannot swallow pills.
  • Have HER2 positive breast cancer.
  • Have had major surgery within three weeks before starting the study.
  • Have untreated or unstable spinal cord compression.

Locations

FACILITYZIPCITYSTATE
University of Alabama at Birmingham35294BirminghamAlabama

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