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RECRUITING
NCT05635487
PHASE2

A Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients

Sponsor: Shengjing Hospital

View on ClinicalTrials.gov

Summary

This is a phase II trial evaluating the efficacy and safety of SHR-A1811 monotherapy or combined with pyrotinib maleate in Stage II-III HER2-positive breast cancer. Subjects will receive the neoadjuvant therapy of SHR-A1811 monotherapy or combined with pyrotinib for six cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. Efficacy will be assessed every 2 cycles.

Official title: A Phase II Study of SHR-A1811 Monotherapy or Combined With Pyrotinib Maleate as Neoadjuvant Treatment in HER2-positive Breast Cancer Patients

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

65

Start Date

2023-03-16

Completion Date

2030-02-28

Last Updated

2024-07-05

Healthy Volunteers

No

Interventions

DRUG

SHR-A1811

SHR-A1811

DRUG

Pyrotinib

Pyrotinib

Locations (1)

Shengjing Hospital affiliated to China Medical University

Shenyang, Liaoning, China