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RC48-ADC in HER2-low Advanced Breast Cancer

Sponsor
RenJi Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05831878
Collaborator
(none)
36
Enrollment
1
Arm
40
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Disitamab vedotin
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Disitamab Vedotin (RC48-ADC) in Patients With HER2-low Advanced Breast Cancer
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2026
Anticipated Study Completion Date :
Aug 1, 2026

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective Response Rate (ORR) [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.

    Secondary Outcome Measures

    1. Adverse events [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Female patients aged 18-70 years (including 18 years and 70 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

    • 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • RenJi Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wenjin Yin, Deputy Chief of Breast Surgery Department, RenJi Hospital
    ClinicalTrials.gov Identifier:
    NCT05831878
    Other Study ID Numbers:
    • LY2023-054-B
    First Posted:
    Apr 26, 2023
    Last Update Posted:
    Apr 26, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Apr 26, 2023