RC48-ADC in HER2-low Advanced Breast Cancer

May 10, 2026 updated by: Wenjin Yin, RenJi Hospital

Disitamab Vedotin (RC48-ADC) in Patients With HER2-low Advanced Breast Cancer

To evaluate the efficacy and safety of Disitamab vedotin (RC48-ADC) as salvage treatment in patients with HER2-low advanced breast cancer who have received up to one previous chemotherapy for recurrent or metastatic disease without previous use of antibody-drug conjugate.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Subjects with HER2-low advanced breast cancer were treated with Disitamab vedotin as salvage treatment. ORR, PFS, OS and AE were assessed during the trial. HER2-low status is defined as IHC1+ or IHC2+ with negative FISH test.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female patients aged ≥18 years
  • Expected survival ≥12 weeks
  • ECOG 0-1
  • Histologically confirmed invasive advanced or metastatic breast cancer that is incurable and unresectable
  • At least one measurable lesion according to the RECIST 1.1
  • No history of antibody-drug conjugate use
  • Up to one previous chemotherapy for advanced disease
  • Available hormone receptor status. Hormone receptor-positive subjects are allowed to receive no more than two previous endocrine therapy for advanced disease
  • HER2-low tumors, defined as IHC1+ or IHC2+ with negative FISH test; or HER2-ultralow tumors, defined as incomplete and faint membrane staining in >0 but ≤10% of tumor cells
  • Adequate organ function

Exclusion Criteria:

  • History of thromboembolic events
  • Uncontrolled systemic diseases, including diabetes, hypertension, interstitial lung disease, cirrhosis, etc.
  • Active infections requiring systemic treatment
  • Pregnant or lactating
  • Presence of brain metastases and/or carcinomatous meningitis

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RC48-ADC
RC48-ADC as salvage treatment for HER2-low advanced breast cancer
Drug: Disitamab vedotin
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
Objective Response Rate (ORR)
Time Frame: From the date of starting Disitamab Vedotin to the date of first documentation of progression or death (up to approximately 1 year)
The percentage of subjects with complete remission (CR) or partial remission (PR) as the best response during the period from the beginning of the treatment to the progression of the disease or the completion of therapy (CR+PR)/Analysis of the total number of people.Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) was used to assess the objective tumor response.
From the date of starting Disitamab Vedotin to the date of first documentation of progression or death (up to approximately 1 year)

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)

May 4, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

April 16, 2023

First Submitted That Met QC Criteria

April 16, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 10, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LY2023-054-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study protocol and SAP are to be shared with other researchers.

IPD Sharing Time Frame

starting 6 months after publication

IPD Sharing Access Criteria

IPD can be accessed from the corresponding author on reasonable request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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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