Real-world Effectiveness and Safety Study of Sacituzumab Govitecan in Chinese Metastatic Breast Cancer

April 4, 2024 updated by: Biyun Wang, MD, Fudan University

Effectiveness and Safety of Sacituzumab Govitecan in Chinese Metastatic Breast Cancer: A Multi-center Real-world Retrospective Study

The aim of this trial is to explore the real-world effectiveness and poteintial predictors of Sacituzumab Govitecan in Chinese metastatic breast cancer patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients aged over 18 years old with metastatic breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.

Description

Inclusion Criteria:

  1. Patients aged over 18 years old.
  2. Metastatic breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
  3. Plan to receive or has received Sacituzumab Govitecan monotherapy
  4. Available medical history.

Exclusion Criteria:

  1. Incomplete medical history.
  2. Pregnancy or breast-breeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sacituzumab Govitecan
Sacituzumab Govitecan,10 mg/kg ivgtt d1, d8, q3w
Drug: Sacituzumab Govitecan
Sacituzumab Govitecan,10 mg/kg ivgtt d1, d8, q3w

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 6 weeks
Progression free survival
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: 6 weeks
Overall Response Rate
6 weeks
OS
Time Frame: 6 weeks
Overall Survival
6 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame: 6 weeks
Safety
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Biyun Wang, Professor, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

April 4, 2024

First Submitted That Met QC Criteria

April 4, 2024

First Posted (Actual)

April 10, 2024

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YOUNGBC-29

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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