Back to resultsRC48-ADC in HER2-low Advanced Breast Cancer
Primary Purpose
Advanced Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Disitamab vedotin
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Breast Cancer
Eligibility Criteria
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
Sites / Locations
- Renji Hospital, School of Medicine, Shanghai Jiaotong UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RC48-ADC
Arm Description
RC48-ADC as salvage treatment for HER2-low advanced breast cancer
Outcomes
Primary Outcome Measures
Objective Response Rate (ORR)
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
Adverse events
Adverse events during Disitamab Vedotin regimen will be assessed according to the NCI CTCAE v5.0.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05831878
Brief Title
RC48-ADC in HER2-low Advanced Breast Cancer
Official Title
Disitamab Vedotin (RC48-ADC) in Patients With HER2-low Advanced Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 4, 2023 (Actual)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
August 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RC48-ADC
Arm Type
Experimental
Arm Description
RC48-ADC as salvage treatment for HER2-low advanced breast cancer
Intervention Type
Drug
Intervention Name(s)
Disitamab vedotin
Other Intervention Name(s)
RC48-ADC
Intervention Description
2.0mg/kg, iv, day1, every 2 weeks
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
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.
Time Frame
From the date of starting Disitamab Vedotin to the date of first documentation of progression or death (up to approximately 1 year)
Secondary Outcome Measure Information:
Title
Adverse events
Description
Adverse events during Disitamab Vedotin regimen will be assessed according to the NCI CTCAE v5.0.
Time Frame
From the date of starting Disitamab Vedotin to the end of the treatment (up to approximately 1 year)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenjin Yin, M.D.
Phone
86(21)68385569
Email
yinwenjin@renji.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenjin Yin, M.D.
Organizational Affiliation
Renji Hospital,School of Medicine, Shanghai Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renji Hospital, School of Medicine, Shanghai Jiaotong University
City
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenjin Yin
Phone
86(21)68385569
Email
yinwenjin@renji.com
12. IPD Sharing Statement
Plan to Share IPD
No
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RC48-ADC in HER2-low Advanced Breast Cancer
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