The Rechallenge of ADCs in MBC Patients

October 17, 2024 updated by: Biyun Wang, MD, Fudan University

A Multicenter, Real-world Study of the Efficacy and Safety of Antibody-drug Conjugates (ADCs) Rechallenge in Patients with Prior Exposure to ADCs Metastatic Breast Cancer

To investigate the efficacy and safety of ADC rechallenge

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

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

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with breast cancer (according to ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.

Description

Inclusion Criteria:

  • age > 18 years old.
  • Diagnosed with Metastatic Breast Cancer.
  • Patients with prior exposure to ADC (either in the adjuvant setting or metastatic disease are allowed).
  • Patients plan to or have received ADCs for the second or more time.
  • Complete medical history was available.

Exclusion Criteria:

  • Medical history was incomplete

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group1
Drug: ADC
Patients with prior exposure to ADC (either in the adjuvant setting or metastatic disease are allowed).

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
OS
Time Frame: 6 weeks
Overall Survival
6 weeks
ORR
Time Frame: 6 weeks
Objective Response Rate
6 weeks
CBR
Time Frame: 6 weeks
Clinical Benefit Rate
6 weeks
DoR
Time Frame: 6 weeks
Duration of Response
6 weeks
Adverse events
Time Frame: 6 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
6 weeks

Collaborators and Investigators

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

Sponsor

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)

September 1, 2022

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

October 5, 2022

First Submitted That Met QC Criteria

October 5, 2022

First Posted (Actual)

October 7, 2022

Study Record Updates

Last Update Posted (Actual)

October 21, 2024

Last Update Submitted That Met QC Criteria

October 17, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YOUNGBC-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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