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.
Histologically or cytologically confirmed breast cancer with HER2 negative status. A copy of the pathology report is required at the time of enrollment.
HER2 negativity will be determined by in situ hybridization (ISH) non- amplified and IHC 0 or 1+ or 2+.
Patients with HR (hormone receptor) positive and triple negative breast cancer (TNBC) will be eligible for enrollment.
Metastatic or locally advanced breast cancer, with at least one measurable lesion according to RECIST (v1.1).
Any history of treatment with Capecitabine in metastatic setting.
Patients who only have non-measurable disease.
Patients with severe hepatic (bilirubin > 3 times upper limit of normal) or renal failure (CrCl < 30 calculated using Cockcroft-Gault formula).
Patients who are unable to swallow pills
Single group
Capecitabine Pill
DrugWill be given once per day by mouth
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.
Progression-free survival (PFS)
Initiation of treatment to the occurrence of disease progression or death. The RECIST v. 1.1 criteria will be used to evaluate progression-free survival as well as CT and PET scans. Baseline to the date of first documented progression to date of death from any cause, whichever comes first, assessed up to 36 months.
Overall survival (OS)
The time which begins at diagnosis (or at the start of treatment) and up to the time of death.
Number of adverse events
Incidence of Treatment-Emergent Adverse Events will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0. Safety, tolerability, satisfaction, and quality of life assessed using the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30) questionnaire, as well as the PRO-CTCAE (Patient reported outcomes - Common Terminology Criteria for Adverse Events) questionnaire.
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