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

Conditions

Metastatic Breast Cancer

Brief 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.

Fei Ma, Min Yan, Wei Li, Quchang Ouyang, Zhongsheng Tong et al. (30 authors)

BMJ2026-03-16

10.1136/bmj-2025-087259

Abstract PS5-01-02: Pyrotinib or placebo in combination with trastuzumab and docetaxel for untreated HER2-positive metastatic breast cancer: long-term survival results from the phase 3 PHILA study

B. Xu, F. Ma, M. Yan, W. Li, Q. Ouyang et al. (30 authors)

Clinical Cancer Research2026-02-17

10.1158/1557-3265.sabcs25-ps5-01-02

Abstract GS1-03: Pyrotinib or placebo in combination with trastuzumab and docetaxel for untreated HER2-positive metastatic breast cancer (mBC): prespecified final analysis of progression-free survival (PFS) of the phase 3 PHILA trial

Binghe Xu, Fei Ma, Min Yan, Wei Li, Quchang Ouyang et al. (30 authors)

Clinical Cancer Research2025-06-13

10.1158/1557-3265.sabcs24-gs1-03

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

Fei Ma, Min Yan, Wěi Li, Quchang Ouyang, Zhongsheng Tong et al. (30 authors)

BMJ2023-10-3171 citations

10.1136/bmj-2023-076065

Interventions

DRUGPyrotinib, Trastuzumab, Docetaxel

Pyrotinib 400mg orally daily until progressive disease

DRUGPlacebo, Trastuzumab, Docetaxel

Placebo 400mg orally daily until progressive disease

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

Healthy volunteers

No

Inclusion criteria

1. HER2 positive recurrent or metastasis breast cancer. 2. Patients with measurable disease are eligible. 3. Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1. 4. Adequate organ function. 5. Signed, written inform consent obtained prior to any study procedure.

Exclusion criteria

1. History of anti-cancer therapy for MBC（with the exception of one prior hormonal regimen for MBC）. 2. History of HER tyrosine kinase inhibitors or monoclonal antibody for breast cancer in any treatment setting，except trastuzumab used in the neo-adjuvant or adjuvant setting. 3. Assessed by the investigator to be unable receive systemic chemotherapy. 4. History of other malignancy within the last 5 years，except for carcinoma in situ of cervix，basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent. 5. Pregnant or lactating women，or for women of childbearing potential unwilling to use a highly-effective contraception during of the study treatment and for at least 7 months after the last dose of study treatment.

Design outcomes

Primary

Measure	Time frame	Description
PFS	Approximately 42 months	Progression Free Survival

Secondary

Measure	Time frame	Description
AEs+SAEs	From the first drug administration to within 28 days for the last treatment	Adverse Events and Serious Adverse Events
OS	Up to 2 years	Overall Survival
ORR	Approximately 42 months	Objective Response Rate
DoR	Approximately 42 months	Duration of Objective Response
CBR	From the start of randomization to 6 months	Clinical Benefit rate

Countries

China

Outcome results

None listed