Tibremciclib or Placebo Plus Fulvestrant in Hormone Receptor–Positive and -Negative Advanced Breast Cancer After Endocrine Therapy

Does the addition of tibremciclib to fulvestrant prolong progression-free survival (PFS) for patients with hormone receptor–positive (HR) and (formerly )–negative () advanced breast cancer (ABC) who experienced progression while receiving prior endocrine therapy (ET)?This phase 3 randomized clinical trial involved 274 patients with HR/ ABC who experienced progression while receiving prior ET. The combination of tibremciclib and fulvestrant significantly improved PFS compared with the combination of placebo plus fulvestrant; the median PFS was 16.5 (95% CI, 12.8-16.6) months in the tibremciclib arm, and the toxic effects were tolerable.The results of this trial suggest that tibremciclib plus fulvestrant provides improvement in PFS for patients with HR/ABC who experienced progression after ET, with a manageable safety profile.

Corresponding Authors: Xichun Hu, MD, Department of Medical Oncology, Fudan University Shanghai Cancer Center; Department of Oncology, Shanghai Medical College, Fudan University, No. 270, Dong’an Road, Xuhui District, Shanghai 200032, China (xchu2009@hotmail.com); Shusen Wang, MD, Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, No. 651, Dongfeng Road East, Yuexiu District, Guangzhou 510060, China (wangshs@sysucc.org.cn).

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