A Study to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel Versus Placebo + Trastuzumab + Docetaxel in Previously Untreated Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer

Summary

This Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial in China will evaluate the efficacy and safety of pertuzumab + trastuzumab + docetaxel compared with placebo + trastuzumab + docetaxel in participants with previously untreated HER2-positive metastatic breast cancer.

Timeline

Start

2016-09-13

Primary completion

2018-06-27

Completion

2021-01-22

Outcome

Met primary endpoint

registry p = 0.0418; Stratified Hazard Ratio 0.69 (95% CI 0.49 to 0.99) NCT02896855 ↗

paper CONCLUSIONS: PUFFIN met its primary objective. PMID 32564260 ↗

Publications

• Xu B, Li W, Zhang Q, Shao Z, Li Q, Wang X, Li H, Sun T, Yin Y, Zheng H, Feng J, Zhang H, Lei G, Restuccia E. Pertuzumab, trastuzumab, and docetaxel for Chinese patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer (PUFFIN): a phase III, randomized, double-blind, placebo-controlled study. Breast Cancer Res Treat. 2020 Aug;182(3):689-697. doi: 10.1007/s10549-020-05728-w. Epub 2020 Jun 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pertuzumab	Monoclonal antibody	420 mg	Intravenous
Background	Docetaxel	Small molecule	75 mg/m2	Intravenous
Background	Trastuzumab	Monoclonal antibody	6 mg/kg	Intravenous

Indications