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.

Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country590 target enrollmentApril 22, 2019

ConditionsMetastatic Breast Cancer

InterventionsPyrotinib, Trastuzumab, Docetaxel Placebo, Trastuzumab, Docetaxel

DrugsPyrotinib, Trastuzumab, Docetaxel Placebo, Trastuzumab, Docetaxel

Overview

Phase: Phase 3
Intervention: Pyrotinib, Trastuzumab, Docetaxel
Conditions: Metastatic Breast Cancer
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 590
Locations: 1
Primary Endpoint: PFS
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 22, 2019

End Date

July 30, 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•HER2 positive recurrent or metastasis breast cancer.
•Patients with measurable disease are eligible.
•Eastern Cooperative Oncology Group(ECOG) performance status 0 or
•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.

Arms & Interventions

A

Pyrotinib Plus trastuzumab and docetaxel

Intervention: Pyrotinib, Trastuzumab, Docetaxel

B

Placebo plus trastuzumab and docetaxel

Intervention: Placebo, Trastuzumab, Docetaxel

Outcomes

Primary Outcomes

PFS

Time Frame: Approximately 42 months

Progression Free Survival

Secondary Outcomes

AEs+SAEs(From the first drug administration to within 28 days for the last treatment)
OS(Up to 2 years)
ORR(Approximately 42 months)
DoR(Approximately 42 months)
CBR(From the start of randomization to 6 months)