NCT05851677

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
15mo left

Started Jun 2023

Longer than P75 for all trials

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 Progress70%
Jun 2023Aug 2027

First Submitted

Initial submission to the registry

April 30, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 10, 2023

Completed
22 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

3.8 years

First QC Date

April 30, 2023

Last Update Submit

September 11, 2025

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-Free Survival

    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 Outcomes (1)

  • Adverse events

    From the date of starting Disitamab vedotin to the end of the treatment (up to approximately 1 year)

Study Arms (1)

RC48-ADC

RC48-ADC for breast cancer

Drug: Disitamab vedotin

Interventions

Disitamab vedotinDRUG

recommended but not required regimen of 2.0mg/kg, iv, day1, every 2 weeks

Also known as: RC48-ADC
RC48-ADC

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, 200127, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

disitamab vedotin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Wenjin Yin, M.D.

    Renji Hospital,School of Medicine, Shanghai Jiaotong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenjin Yin, M.D.

CONTACT

86(21)68385569yinwenjin@renji.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Chief of Breast Surgery Department

Study Record Dates

First Submitted

April 30, 2023

First Posted

May 10, 2023

Study Start

June 1, 2023

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

September 17, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)