Pyrotinib Combined With Trastuzumab And Chemotherapy in HER2-positive MBC

• Conditions: Metastatic Breast Cancer; HER2-positive Breast Cancer
• Interventions: Drug: Trastuzumab

• Registration Number: NCT04609540
• Lead Sponsor: Shandong Cancer Hospital and Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-24
• Study First Submitted QC: 2020-10-24
• Study First Posted: 2020-10-30
• Last Update Submitted: 2020-12-14
• Last Update Posted: 2020-12-16
• Study Start: 2021-01-01
• Primary Completion: 2021-12-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

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

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pyrotinib and Trastuzumab group	Trastuzumab	Dual anti-HER2 therapy (pyrotinib and trastuzumab) and chemotherapy

Primary Outcome Measures

Name	Time	Method
Progression free survival(PFS)	1 year	The time from starting pyrotinib until disease progression or death from any cause.

Secondary Outcome Measures

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