Phase II Single Arm Trial of Low Dose Capecitabine in Patients With Advanced Breast Cancer
University of Alabama at Birmingham
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.
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 pati…
Eligibility
- Age range
- 60+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Histologically or cytologically confirmed breast cancer with HER2 negative status. A copy of the pathology report is required at the time of enrollment. 1. HER2 negativity will be determined by in situ hybridization (ISH) non- amplified and IHC 0 or 1+ or 2+. 2. Patients with HR (hormone receptor) positive and triple negative breast cancer (TNBC) will be eligible for enrollment. 2. Metastatic or locally advanced breast cancer, with at least one measurable lesion according to RECIST (v1.1). 3. ECOG performance status of 0-2. 4. Patients must have progressed on at…
Interventions
- DrugCapecitabine Pill
Will be given once per day by mouth
Location
- University of Alabama at BirminghamBirmingham, Alabama