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RECRUITING
NCT07678957
PHASE2

A Study Comparing BL-M07D1 With DS-8201 in Patients With HR-Positive, HER2-Low Expressing Recurrent/Metastatic Breast Cancer

Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

This trial is a randomized, open-label, multicenter Phase II study designed to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable locally recurrent or metastatic HR-positive, HER2-low expressing breast cancer.

Official title: A Randomized Controlled Phase II Clinical Study Comparing BL-M07D1 With DS-8201 in Patients With HR-Positive, HER2-Low Expressing Recurrent/Metastatic Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-08-31

Completion Date

2028-12

Last Updated

2026-09-14

Healthy Volunteers

No

Conditions

Interventions

DRUG

BL-M07D1

Administration by intravenous infusion for a cycle of 3 weeks.

DRUG

DS-8201

Administration by intravenous infusion for a cycle of 3 weeks.

Locations (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China