The Absolute Effect / Evidence index
Advanced / Metastatic · Randomized phase III; N=417 women with HR+/HER2− advanced breast cancer. Fovinaciclib+letrozole/anastrozole vs placebo+AI. Primary endpoint BICR PFS. · Median PFS not reached vs 20.2 months
Fovinaciclib phase III trial
Clinical question: Does adding fovinaciclib to an aromatase inhibitor improve PFS in first-line HR-positive/HER2-negative advanced breast cancer?
Median PFS not reached vs 20.2 months; HR 0.55 (95% CI 0.38–0.77; one-sided P<0.001); OS immature. · Registry:
Design, population and treatment
Randomized phase III; N=417 women with HR+/HER2− advanced breast cancer. Fovinaciclib+letrozole/anastrozole vs placebo+AI. Primary endpoint BICR PFS.
Key efficacy outcome
Fovinaciclib + aromatase inhibitor
Median PFS not reached
Placebo + aromatase inhibitor
Median PFS 20.2 months
HR 0.55 (95% CI 0.38–0.77; one-sided P<0.001). Overall survival was immature.
Safety and absolute effect
Median PFS (months)
https://jamanetwork.com/journals/jamaoncology/article-abstract/2849872
Interpretation and limitations
Current-practice context · 14 November 2026: Primary publication/abstract and trial identifier checked. Guideline-level current-practice mapping was not established in this publication-led batch; no NCCN citation provenance is claimed. Where detailed QoL, follow-up or toxicity data were not present in the retrieved abstract, they are not inferred.