Purpose: Capecitabine, an oral prodrug of 5-fluorouracil (5-FU), is a widely used chemotherapeutic agent in metastatic breast cancer (MBC), particularly after anthracycline and taxane failure. This study evaluates its efficacy and safety when used as monotherapy or in combination regimens in women with MBC.

Methods: This prospective observational study included female MBC patients treated with capecitabine-based regimens. Clinical endpoints included overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and toxicity profile. Data were analyzed using descriptive and inferential statistics.

Results: Among the study cohort, capecitabine monotherapy achieved an ORR of 35%, median PFS of 5.1 months, and OS of 15.2 months. Combination regimens such as capecitabine–vinorelbine and capecitabine–docetaxel showed higher ORRs (49–61%) and longer PFS (6.1–12 months) but with increased grade 3–4 toxicities. The most common adverse events were hand–foot syndrome (28–55%), diarrhea (15–30%), and fatigue (10–25%), generally manageable by dose modification.

Conclusion: Capecitabine-based regimens are effective and tolerable in women with MBC, with combination therapies offering higher response rates at the cost of slightly increased toxicity. Individualized regimen selection is recommended.