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NOT YET RECRUITING
NCT07556848
PHASE3

A Study of 9MW2821 Versus Chemotherapy in Participants With Previously Treated Locally Advanced or Metastatic Triple-Negative Breast Cancer

Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the efficacy and safety of 9MW2821 versus investigator's choice of chemotherapy in participants with locally advanced or metastatic triple-negative breast cancer who have previously received taxane-based chemotherapy with or without immunotherapy and an antibody-drug conjugate with a topoisomerase inhibitor payload

Official title: A Randomized, Open-label, Phase 3 Study to Evaluate 9MW2821 Versus Investigator's Choice of Chemotherapy in Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer Who Have Previously Received Taxane-based Chemotherapy With or Without Immunotherapy and an Antibody-drug Conjugate With a Topoisomerase Inhibitor Payload

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

356

Start Date

2026-05

Completion Date

2028-09

Last Updated

2026-04-30

Healthy Volunteers

No

Interventions

DRUG

9MW2821

Subjects will receive intravenous (IV) infusion of 9MW2821 as per protocol

DRUG

Chemotherapy

Participants will receive investigator's choice of chemotherapy determined prior to randomization from 1 of the 4 allowed regimens as per protocol: eribulin, or vinorelbine or capecitabine or gemcitabine.

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China