The use of endpoints in phase 3 randomized controlled trials in metastatic breast cancer - PubMed
6 hours ago
- #metastatic breast cancer
- #phase 3 RCT
- #clinical trial endpoints
- The study analyzed 267 phase 3 randomized controlled trials (RCTs) in metastatic breast cancer started between 2008 and 2025.
- Progression-free survival (PFS) was the most common primary endpoint (85.4%), while overall survival (OS) was used in only 13.1% of trials.
- Trials of chemotherapy were less likely to use PFS as the primary endpoint compared to those testing conjugates.
- OS as a primary endpoint was more likely in trials enrolling patients with triple-negative breast cancer (TNBC) relative to HER2+ BC.
- Among PFS-based trials with results, the median improvement in PFS was modest at 2.8 months.
- 81.1% of trials with PFS as the primary endpoint included OS as a secondary endpoint, and 47.4% included quality of life (QoL) as a secondary endpoint.
- The line of treatment did not significantly impact the odds of using OS as the primary endpoint.
- The conclusion recommends using OS as the primary endpoint more frequently, especially in TNBC and later-line treatments, and including QoL as a secondary endpoint more often.