A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4]

Summary

The study is designed to compare the clinical benefit following treatment with letrozole in combination with Palbociclib versus letrozole in combination with placebo in Asian postmenopausal women with ER(+)/HER2(-) advanced breast cancer who have not received prior systemic anti cancer therapies for their advanced/metastatic disease.

Timeline

Start

2015-03-23

Primary completion

2020-08-31

Completion

2025-02-24

Outcome

Met primary endpoint

paper Median (95% CI) PFS was 21.5 (16.6-24.9) months with palbociclib plus letrozole and 13.9 (13.7-16.6) months with placebo plus letrozole PMID 36155117 ↗

paper hazard ratio, 0.68 [95% CI, 0.53-0.87]; P = 0.0012 PMID 36155117 ↗

Publications

• Xu B, Hu X, Li W, Sun T, Shen K, Huang C, Sriuranpong V, Ngan RK, Chia YH, Reisman A, Zhao H, Shen J, Broughton E. Patient-reported quality of life in Asian patients with ER+/HER2- advanced breast cancer treated with palbociclib plus letrozole in the PALOMA-4 trial. Chin Med J (Engl). 2024 Dec 19. doi: 10.1097/CM9.0000000000003122. Online ahead of print.
• Xu B, Hu X, Li W, Sun T, Shen K, Wang S, Cheng Y, Zhang Q, Cui S, Tong Z, Geng C, Song E, Huang CS, Sriuranpong V, Ngan RKC, Chia YH, Wang X, Zhao H. Palbociclib plus letrozole versus placebo plus letrozole in Asian postmenopausal women with oestrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: Primary results from PALOMA-4. Eur J Cancer. 2022 Nov;175:236-245. doi: 10.1016/j.ejca.2022.08.012. Epub 2022 Sep 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Palbociclib	Small molecule	125 mg	Oral
Comparator	Letrozole	Other / unclassified	2.5 mg	Oral

Indications