Phase II Single Arm Trial of Low Dose Capecitabine in Patients With Advanced Breast Cancer
Summary
This is a phase II study aiming at evaluating capecitabine prospectively at a dose of 1000 mg once daily in patients with advanced breast cancer who are ≥60 years of age, or frail at any age, with a greater risk of complications and poorer outcomes with other treatments.
Detailed description
The study is a phase II, single arm study in which all patients will receive the study drug. Participants will include older/frail patients with metastatic breast cancer. All patients will be treated with capecitabine 1000 mg daily. There will be a total of 40 participants with measurable disease on this trial. The study will encompass participants with locally advanced unresectable/metastatic breast cancer with measurable disease, who progressed on at least 1 prior therapy in the metastatic setting. Breast cancer subtypes include HR+ HER2 negative, or TNBC, age ≥ 60 years old, or frail patients at a younger age. ECOG PS 0- 2. The study will discontinue if progressive disease or unacceptable toxicity is noted.
Arms & interventions
- DrugCapecitabine Pill
Will be given once per day by mouth
Outcome measures
Primary
Objective response rate (RR) evaluation
Evaluate response rate (RR) as defined per Response Evaluation Criteria in Solid Tumors (RECIST) criteria (v 1.1). Response and progression of disease will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee; version 1.1. Patients will be evaluated for response every 12 weeks per RECIST Criteria.
Time frame: Baseline up to 12 weeks
Secondary
Progression-free survival (PFS)
Time frame: Up to 36 months
Overall survival (OS)
Time frame: Baseline up to 36 months
Number of adverse events
Time frame: Baseline up to 36 months
Eligibility criteria
Study locations (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35294