Sacituzumab Govitecan in Chinese Patients With mTNBC of at Least 2 Prior Treatments

  • STATUS
    Recruiting
  • End date
    Nov 27, 2022
  • participants needed
    80
  • sponsor
    Everest Medicines
Updated on 21 March 2021

Summary

The purpose of this study is to evaluate the efficacy and safety of sacituzumab govitecan in Chinese patients with metastatic triple-negative breast cancer (TNBC) who received at least two prior chemotherapy treatments.

Description

This is a Phase IIb, single arm, multicenter study of sacituzumab govitecan in locally advanced or metastatic TNBC patients who are refractory or relapsing after at least 2 prior standard chemotherapy regimens for unresectable, locally advanced or metastatic breast cancer, and these regimens will qualify regardless of triple-negative status at the time they were given. The primary endpoint of the trial will be the ORR per RECIST v 1.1 by Independent Review Committee (IRC) in all treated patients.

Patients will be treated until progression requiring discontinuation of further treatment, unacceptable toxicity, study withdrawal, or death, whichever comes first. Tumor response and progression will be assessed using RECIST v 1.1 and assessment by Investigator at the trial center will be sufficient for decisions on continuation of treatment. An independent analysis of response will also be performed by IRC, but this will not be used to make treatment decisions. All patients will visit the Investigator at regular intervals for assessment of safety parameters and AEs.

Details
Condition Metastatic Triple Negative Breast Cancer
Treatment Sacituzumab govitecan
Clinical Study IdentifierNCT04454437
SponsorEverest Medicines
Last Modified on21 March 2021

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