Pyrotinib Plus Trastuzumab and Chemotherapy in HER2+ Metastatic Breast Cancer Patients

Completed

• Conditions: Breast Cancer

• Registration Number: NCT05839288
• Lead Sponsor: Fudan University

Brief Summary

To evaluate the patterns and treatment outcomes of pyrotinib plus trastuzumab and chemotherapy in the real world.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-01
• Primary Completion: 2023-03-01
• Status Verified: 2023-04
• Study Completion: 2023-04-01
• Study First Submitted: 2023-04-03
• Study First Submitted QC: 2023-04-20
• Last Update Submitted: 2023-04-20
• Study First Posted: 2023-05-03
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 161

Inclusion Criteria

• woman, age > 18 years old
• diagnosed with HER2 +Metastatic Breast Cancer
• received pyrotinib plus trastuzumab and chemotherapy for at least one cycle, starting from 2018.07-2022.09
• available medical history

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Exclusion Criteria

• medical history was incomplete

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
progression-free survival (PFS)	6 weeks	Progression free survival

Secondary Outcome Measures

Name	Time	Method
Adverse events	6 weeks	Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China