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

NCT ID: NCT04246502

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-31
• Study Completion Date: 2024-12-31

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.

Conditions

Metastatic Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

A

Group Type: EXPERIMENTAL

Capecitabine and Pyrotinib

Intervention Type: DRUG

Pyrotinib 400mg orally daily until progressive disease

B

Group Type: ACTIVE_COMPARATOR

Capecitabine,Trastuzumab, and Pertuzumab

Intervention Type: DRUG

as instruction

Interventions

Capecitabine and Pyrotinib

Pyrotinib 400mg orally daily until progressive disease

Intervention Type: DRUG

Capecitabine,Trastuzumab, and Pertuzumab

as instruction

Intervention Type: DRUG

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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shandong Cancer Hospital and Institute

OTHER

Sponsor Role: lead

Responsible Party

Zhiyong Yu

Shandong Breast Disease Centre

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Shandong CHI-11

Identifier Type: -

Identifier Source: org_study_id