Clinical trial · Interventional
A Study of Pyrotinib in Combination With Trastuzumab and Docetaxel in Patients With HER2 Metastatic Breast Cancer
A Phase 3,Randomized, Double-blinded, Placebo-controlled Study to Evaluate Efficacy and Safety of Pyrotinib Plus Trastuzumab and Docetaxel Versus Placebo Plus Trastuzumab and Docetaxel in Patients With HER2 Positive MBC.
NCT03863223CI-TRIAL-00062320unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo, Trastuzumab, Docetaxel | Drug | — | UNRESOLVED |
| Pyrotinib, Trastuzumab, Docetaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- Pyrotinib Plus trastuzumab and docetaxel
- interventionNames
- Drug: Pyrotinib, Trastuzumab, Docetaxel
- type
- PLACEBO_COMPARATOR
- label
- B
- description
- Placebo plus trastuzumab and docetaxel
- interventionNames
- Drug: Placebo, Trastuzumab, Docetaxel
Primary outcomes (1)
- measure
- PFS
- timeFrame
- Approximately 42 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDMa 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. PMID 41839514
- DERIVEDMa 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. PMID 37907210