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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Metastatic Breast Cancer

Intervention / Treatment
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* Drug: Pyrotinib, Trastuzumab, Docetaxel
* Drug: Placebo, Trastuzumab, Docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HER2 positive recurrent or metastasis breast cancer. Patients with measurable disease are eligible. Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1. Adequate organ function. Signed, written inform consent obtained prior to any study procedure. Exclusion Criteria: History of anti-cancer therapy for MBC（with the exception of one prior hormonal regimen for MBC）. 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. Assessed by the investigator to be unable receive systemic chemotherapy. 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Pyrotinib Plus trastuzumab and docetaxel | Drug: Pyrotinib, Trastuzumab, Docetaxel<br>* Pyrotinib 400mg orally daily until progressive disease<br>|
| Placebo Comparator: B<br>Placebo plus trastuzumab and docetaxel | Drug: Placebo, Trastuzumab, Docetaxel<br>* Placebo 400mg orally daily until progressive disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression Free Survival | Approximately 42 months | 

Secondary Outcome Measures

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