Disitamab Vedotin (RC48-ADC) in Breast Cancer

September 11, 2025 updated by: Wenjin Yin, RenJi Hospital

Disitamab Vedotin (RC48-ADC) in Patients With Breast Cancer: a Real-world Study

To evaluate the efficacy and safety of Disitamab vedotin (RC48-ADC) in patients with breast cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

45

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, China, 200127
        • Recruiting
        • Renji Hospital, School of Medicine, Shanghai Jiaotong University
        • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

breast cancer patients with prior or current use of Disitamab vedotin (RC48-ADC)

Description

Inclusion Criteria:

  • Histologically confirmed breast cancer;
  • Prior or current use of Disitamab vedotin (RC48-ADC);

Exclusion Criteria:

  • Participating in clinical trials involving Disitamab vedotin (RC48-ADC) or not.

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
RC48-ADC
RC48-ADC for breast cancer
Drug: Disitamab vedotin
recommended but not required regimen of 2.0mg/kg, iv, day1, every 2 weeks
Other Names:
  • RC48-ADC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival
Time Frame: From the date of starting Disitamab vedotin to the date of first documentation of progression or death (up to approximately 1 years)
The time from the date of starting Disitamab Vedotin to the date of disease progression as per RECIST version 1.1 or death from any cause, whichever occurs first.
From the date of starting Disitamab vedotin to the date of first documentation of progression or death (up to approximately 1 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: From the date of starting Disitamab vedotin to the end of the treatment (up to approximately 1 year)
Adverse events during Disitamab Vedotin regimen will be assessed according to the NCI CTCAE v5.0.
From the date of starting Disitamab vedotin to the end of the treatment (up to approximately 1 year)

Collaborators and Investigators

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

Sponsor

RenJi Hospital

Investigators

  • Principal Investigator: Wenjin Yin, M.D., Renji Hospital,School of Medicine, Shanghai Jiaotong 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)

June 1, 2023

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

April 30, 2023

First Submitted That Met QC Criteria

April 30, 2023

First Posted (Actual)

May 10, 2023

Study Record Updates

Last Update Posted (Estimated)

September 17, 2025

Last Update Submitted That Met QC Criteria

September 11, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LY2023-062-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Breast Cancer

Clinical Trials on Disitamab vedotin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe