NCT06356519

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 4, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

1 year

First QC Date

April 4, 2024

Last Update Submit

April 4, 2024

Conditions

Breast Cancer

Keywords

Sacituzumab Govitecanbreast cancer

Outcome Measures

Primary Outcomes (1)

  • PFS

    Progression free survival

    6 weeks

Secondary Outcomes (3)

  • ORR

    6 weeks

  • OS

    6 weeks

  • Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    6 weeks

Study Arms (1)

Sacituzumab Govitecan

Sacituzumab Govitecan,10 mg/kg ivgtt d1, d8, q3w

Drug: Sacituzumab Govitecan

Interventions

Sacituzumab GovitecanDRUG

Sacituzumab Govitecan,10 mg/kg ivgtt d1, d8, q3w

Sacituzumab Govitecan

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Incomplete medical history.
  • Pregnancy or breast-breeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

sacituzumab govitecan

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Biyun Wang, Professor

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Biyun Wang, Professor

CONTACT

+8613701748410pro_wangbiyun@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 4, 2024

First Posted

April 10, 2024

Study Start

March 1, 2024

Primary Completion

March 1, 2025

Study Completion

April 1, 2025

Last Updated

April 10, 2024

Record last verified: 2024-04

Locations

CN(1)