Phase III Trial Comparing Fulvestrant and Capecitabine as Maintenance Treatment After First-Line Chemotherapy in Women With Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer

What this Trial Is About

Researchers are evaluating the effectiveness and safety of two maintenance treatments, fulvestrant and capecitabine, for women with hormone receptor-positive, human epidermal growth factor receptor-2 negative metastatic breast cancer. This phase III trial compares these options after patients have completed first-line chemotherapy. The goal is to determine which treatment better delays disease progression while maintaining quality of life. Participants receive either fulvestrant injections at specific intervals days 0, 14, 28, then every 28 days or capecitabine orally in cycles of 14 days on treatment followed by 7 days off. The study is randomized and open-label, involving multiple centers. The trial includes a treatment period with ongoing monitoring for adverse events and quality of life. During the study, participants undergo imaging tests to assess tumor status before starting maintenance therapy, along with regular blood tests and liver and kidney function checks. Researchers track progression-free survival over an estimated 18 months and evaluate overall survival, response rates, clinical benefit, and quality of life up to five years. Safety is monitored from consent through 28 days after treatment ends, ensuring comprehensive participant follow-up.

Fulvestrant Versus Capecitabine as Maintenance Therapy After First-line Chemotherapy in Patients With HR+/HER2- Metastatic Breast Cancer