Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT07829900

First-Line Dual Versus Single HER2-Targeted Therapy With Docetaxel for Advanced HER2-Positive Breast Cancer

Sponsor: Xin Li

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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.

DRUG

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