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

Metastatic Breast Cancer Clinical Trial

Official title:

A Phase 2,Randomized, Evaluate Efficacy and Safety of Capecitabine Plus Pyrotinib Versus Capecitabine Plus Trastuzumab and Pertuzumab in the First-line Treatment of HER2-positive Metastatic Breast Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04246502
• Other study ID #: Shandong CHI-11
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 2020
• Est. completion date: December 2024

Study information

• Verified date: January 2020
• Source: Shandong Cancer Hospital and Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Capecitabine and Pyrotinib
Pyrotinib 400mg orally daily until progressive disease
• Capecitabine,Trastuzumab, and Pertuzumab
as instruction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Cancer Hospital and Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival		Approximately 42 months
Secondary	Adverse Events and Serious Adverse Events	AEs+SAEs	From the first drug administration to within 28 days for the last treatment
Secondary	Overall Survival		Up to 2 years
Secondary	Objective Response Rate		Approximately 42 months
Secondary	Duration of Objective Response		Approximately 42 months
Secondary	Clinical Benefit rate		From the start of randomization to 6 months