Metastatic Breast Cancer Clinical Trial
Official title:
Phase II Single Arm Trial of Low Dose Capecitabine in Patients With Advanced Breast Cancer
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.
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. ;
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