Dual Anti-HER2 Therapy (Lapatinib and Trastuzumab) Plus Chemotherapy in HER2-positive MBC

Completed

• Conditions: Breast Cancer

• Registration Number: NCT04001634
• Lead Sponsor: Fudan University

Brief Summary

To explore the real world situation of trastuzumab and lapatinib combined chemotherapy in China, and to explore the relationship between progression free survival and treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2019-05-15
• Study First Submitted: 2019-06-27
• Study First Submitted QC: 2019-06-27
• Study First Posted: 2019-06-28
• Study Completion: 2020-08-15
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 285

Inclusion Criteria

• 1. woman, age > 18 years old 2. Diagnosed with HER2 +Metastatic Breast Cancer 3. Dual anti-HER2 therapy (lapatinib and trastuzumab) plus chemotherapy for at least one cycle, starting from 2013.09.01-2019.07.31 4. Available medical history

Exclusion Criteria

• 1. Incomplete medical history

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ORR	6 weeks	Objective Response Rate
PFS	6 weeks	Progression free survival
OS	6 weeks	Overall survival

Secondary Outcome Measures

Name	Time	Method
Treatment Pattern	6 weeks	Choice of Treatment

Trial Locations

Locations (1)

Biyun Wang, MD; 🇨🇳 Shanghai, Shanghai, China