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NCT04609540 Clinical Trial

Pyrotinib Combined With Trastuzumab And Chemotherapy in HER2-positive MBC

Metastatic Breast Cancer Clinical Trial

Official title:
Pyrotinib Combined With Trastuzumab and Chemotherapy in HER2-positive Metastatic Breast Cancer Patients- a Multicenter Retrospective Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04609540
Other study ID # ShandongCHI-14
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date June 1, 2022

Study information
Verified date October 2020
Source Shandong Cancer Hospital and Institute
Contact Zhiyong Yu, PhD
Phone 86-13355312277
Email drzhiyongyu@aliyun.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To explore the real world data of trastuzumab Combined With Trastuzumab And Chemotherapy in China, and to explore the relationship between progression free survival and treatment pattern.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date June 1, 2022
Est. primary completion date December 1, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - woman, age > 18 years old - Diagnosed with HER2 +Metastatic Breast Cancer - Pyrotinib Combined With Trastuzumab And Chemotherapy for at least one cycle, starting from 2020.11.01-2021.10.31 - Available medical history Exclusion Criteria: - Incomplete medical history

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Trastuzumab
Dual anti-HER2 therapy

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(PFS) The time from starting pyrotinib until disease progression or death from any cause. 1 year
Secondary Overall survival(OS) The time from starting pyrotinib until death, regardless of cause. 1 year
Secondary Objective Response Rate(ORR) The proportion of patients with complete response (CR) or partial response (PR) 1 year
Secondary Safety Number of participants with adverse events which were collected at 6 and 18 months after the start of pyrotinib 1 year
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