Capecitabine Plus Pyrotinib Versus Capecitabine Plus Trastuzumab and Pertuzumab in the First-line Treatment of HER2-positive Metastatic Breast Cancer

Phase 2

Not yet recruiting

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: Capecitabine,Trastuzumab, and Pertuzumab; Drug: Capecitabine and Pyrotinib

• Registration Number: NCT04246502
• Lead Sponsor: Shandong Cancer Hospital and Institute

Brief Summary

This is a randomized, multicenter phase 2 clinical trial to evaluate the efficacy and safety of capecitabine plus pyrotinib versus capecitabine plus trastuzumab plus pertuzumab 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

• Status Verified: 2020-01
• Study Start: 2020-01
• Study First Submitted: 2020-01-28
• Study First Submitted QC: 2020-01-28
• Study First Posted: 2020-01-29
• Last Update Submitted: 2020-01-30
• Last Update Posted: 2020-02-05
• Primary Completion: 2022-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Capecitabine,Trastuzumab, and Pertuzumab	-
A	Capecitabine and Pyrotinib	-

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	Approximately 42 months

Secondary Outcome Measures

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