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

Phase 3

Active, not recruiting

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: Pyrotinib, Trastuzumab, Docetaxel; Drug: Placebo, Trastuzumab, Docetaxel

• Registration Number: NCT03863223
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-01
• Study First Submitted QC: 2019-03-03
• Study First Posted: 2019-03-05
• Study Start: 2019-04-22
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-21
• Last Update Posted: 2022-11-23
• Primary Completion: 2022-12-30
• Study Completion: 2024-07-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 590

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Pyrotinib, Trastuzumab, Docetaxel	Pyrotinib Plus trastuzumab and docetaxel
B	Placebo, Trastuzumab, Docetaxel	Placebo plus trastuzumab and docetaxel

Primary Outcome Measures

Name	Time	Method
PFS	Approximately 42 months	Progression Free Survival

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Cancer Institute and Hospital,Chinese Academy of Medical Science; 🇨🇳 Beijing, Beijing, China