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First-Line Dual Versus Single HER2-Targeted Therapy With Docetaxel for Advanced HER2-Positive Breast Cancer
Sponsor: Xin Li
Summary
This retrospective observational cohort study emulates a target trial to compare the effectiveness and safety of two first-line treatment strategies for women with HER2-positive unresectable locally advanced, recurrent, or metastatic breast cancer in routine clinical practice: pertuzumab plus trastuzumab and docetaxel versus trastuzumab and docetaxel. Data were obtained from electronic health records held by the National Health and Medical Big Data (Eastern) Center and linked with the Jiangsu Provincial Mortality Registry. Eligible patients initiated one of the two treatment strategies between January 1, 2020, and December 31, 2024. Time zero was defined as the date of the first administration of the qualifying first-line regimen. No minimum number of treatment cycles was required. The primary outcome was overall survival. Secondary outcomes included progression-free survival and prespecified adverse events.
Official title: Real-world Comparative Effectiveness and Safety of Pertuzumab Plus Trastuzumab vs Trastuzumab as First-line Treatment for Advanced HER2-positive Breast Cancer: A Target Trial Emulation Study
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
2250
Start Date
2020-04-20
Completion Date
2024-12-31
Last Updated
2026-09-21
Healthy Volunteers
No
Interventions
Pertuzumab
Pertuzumab administered as part of first-line dual HER2-targeted therapy with trastuzumab and docetaxel. Exposure was identified from electronic prescriptions, medication orders, and administration records.
Trastuzumab
Trastuzumab administered as part of first-line HER2-targeted therapy with docetaxel, with or without pertuzumab. Exposure was identified from electronic prescriptions, medication orders, and administration records.
Docetaxel
Docetaxel administered as first-line chemotherapy in combination with HER2-targeted therapy. Exposure was identified from electronic prescriptions, medication orders, and administration records.
Locations (1)
Nanjing Medical University
Nanjing, Jiangsu, China