A Study of Pyrotinib in Combination With Trastuzumab and Docetaxel in Patients With HER2 Metastatic Breast Cancer

Summary

This is a randomized, double-blinded, multicenter phase 3 clinical trial to evaluate the efficacy and safety of pyrotinib plus trastuzumab plus docetaxel versus placebo plus trastuzumab plus docetaxel in patients who have HER2 positive metastatic breast cancer and have not received systemic anticancer therapy for advanced disease.

Timeline

Start

2019-04-22

Primary completion

2022-12-30

Completion

2024-07-30

Outcome

Met primary endpoint

paper the median progression-free survival according to the investigator was significantly longer in the pyrotinib group than in the placebo group PMID 37907210 ↗

paper Pyrotinib, trastuzumab, and docetaxel showed superiority by significantly improving progression-free survival compared with placebo, trastuzumab, and docetaxel PMID 37907210 ↗

Publications

• Ma F, Yan M, Li W, Ouyang Q, Tong Z, Teng Y, Wang Y, Wang S, Geng C, Luo T, Zhong J, Zhang Q, Liu Q, Zeng X, Sun T, Mo Q, Zhou S, Li P, Cheng J, Wang X, Nie J, Yang J, Wu X, Wang X, Li H, Yao G, Fan Y, Lin J, Zhu X, Xu B. Pyrotinib or placebo in combination with trastuzumab and docetaxel for HER2 positive metastatic breast cancer: long term survival results from randomised phase 3 PHILA trial. BMJ. 2026 Mar 16;392:e087259. doi: 10.1136/bmj-2025-087259.
• Ma F, Yan M, Li W, Ouyang Q, Tong Z, Teng Y, Wang Y, Wang S, Geng C, Luo T, Zhong J, Zhang Q, Liu Q, Zeng X, Sun T, Mo Q, Liu H, Cheng Y, Cheng J, Wang X, Nie J, Yang J, Wu X, Wang X, Li H, Ye C, Dong F, Wu S, Zhu X, Xu B; PHILA Investigators. Pyrotinib versus placebo in combination with trastuzumab and docetaxel as first line treatment in patients with HER2 positive metastatic breast cancer (PHILA): randomised, double blind, multicentre, phase 3 trial. BMJ. 2023 Oct 31;383:e076065. doi: 10.1136/bmj-2023-076065.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pyrotinib	Small molecule	400 mg	Oral
Background	Docetaxel	Small molecule	75 mg/m2	Intravenous
Background	Trastuzumab	Monoclonal antibody	6 mg/kg	Intravenous

Indications