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NOT YET RECRUITING
NCT07760844
PHASE3

An Open-Label, Randomized Phase III Study of Trastuzumab Rezetecan With or Without Everolimus in First to Third Line LAR Subtype TNBC

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

This study is a prospective, open-label, phase III, randomized controlled clinical trial. It is planned to screen patients with inoperable locally advanced or metastatic triple-negative breast cancer of the LAR subtype. A total of 180 patients are planned to be enrolled.

Official title: A Randomized Phase III Study of Trastuzumab Rezetecan With or Without Everolimus as First- to Third-Line Treatment for Luminal Androgen Receptor Subtype of Triple-Negative Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2026-10-01

Completion Date

2029-03-30

Last Updated

2026-08-12

Healthy Volunteers

No

Interventions

DRUG

SHR- A1811+ eve

SHRA1811(HER-targeted ADC) 4.8 mg/kg, administered via intravenous infusion on Day 1 of each 3-week cycle. Everolimus administered at a fixed dose of 5 mg orally, once daily, continuously.

DRUG

SHR- A1811

SHRA1811(HER-targeted ADC) 4.8 mg/kg, administered via intravenous infusion on Day 1 of each 3-week cycle