Phase II Single Arm Trial of Low Dose Capecitabine in Patients With Advanced Breast Cancer
Trial Parameters
Brief 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.
Eligibility Criteria
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 least 1 prior line of therapy in the metastatic setting (hormonal therapy or chemotherapy) 5. Adequate organ function as evidenced by: 1. ANC \>1.5 x 10⁹/L (1500/µL) or \> 1.3 x 10⁹/L (1300/µL) for patients with history of benign ethnic neutropenia. 2. Platelet count ≥100,000/µL (without transfusion within 2 weeks prior to initiation of study treatment (Cycle 1, day 1)). 3. Hemoglobin ≥9.0 g/dl. Patients