Back to resultsRC48 for Neoadjuvant Chemotherapy of HER2 Positive Breast Cancer
Primary Purpose
Breast Cancer, HER2-positive Breast Cancer
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Recombinant humanized anti-HER2 monoclonal antibody-MMAE coupling agent (RC48-ADC)
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Enrolled were ≥ 18 years of age and < 80 years of age
- Female or male breast cancer
- Patients with early or locally advanced breast cancer who are HER2-positive, have a tumor larger than 2 cm and/or have lymph node metastasis: HER2-positive is defined as 3 + by immunohistochemistry, or 2 + by immunohistochemistry, with a positive FISH test.
- Left ventricular score ≥ 55%
- ECOGPS score 0 or 1
- Able to understand the test requirements, willing and able to comply with the test and follow-up procedures
- Adequate organ function
Exclusion Criteria:
- cardiac, hepatic, renal, or psychiatric disease history
- History of other malignancy within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RC48 for neadjuvant chemotherapy
Arm Description
RC48-ADC: 2.0 mg/kg, IV drip, Q2W
Outcomes
Primary Outcome Measures
Pathological complete response rate (pCR)
absence of invasive carcinoma in the breast and axillary lymph nodes, while residual ductal carcinoma in situ was accepted (ypT0orTisypN0).
Secondary Outcome Measures
adverse effects
Serious adverse effect occur within neoadjuvant chemotherapy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05134519
Brief Title
RC48 for Neoadjuvant Chemotherapy of HER2 Positive Breast Cancer
Official Title
Phase II Clinical Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Coupling Agent (RC48-ADC) for Neoadjuvant Treatment of Breast Cancer With Positive HER2 Expression (Seraph)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 26, 2021 (Anticipated)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a single-arm exploratory study to explore the effect of RC48 in HER2-positive neoadjuvant therapy and evaluate the non-inferiority of RC48 by comparing the latest reported data of T-DM1 in neoadjuvant therapy.
Detailed Description
A single-arm exploratory study was conducted in 20 patients with HER2-positive breast cancer to explore the effect of RC48 in HER2-positive neoadjuvant therapy (treatment regimen: RC482.0 mg/kg, intravenous drip, once every 2 weeks). After 4-6 cycles, surgery was performed to evaluate the effect of neoadjuvant chemotherapy. The latest reported data of T-DM1 in neoadjuvant therapy were compared to evaluate the non-inferiority of RC48.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, HER2-positive Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RC48 for neadjuvant chemotherapy
Arm Type
Experimental
Arm Description
RC48-ADC: 2.0 mg/kg, IV drip, Q2W
Intervention Type
Drug
Intervention Name(s)
Recombinant humanized anti-HER2 monoclonal antibody-MMAE coupling agent (RC48-ADC)
Other Intervention Name(s)
RC48
Intervention Description
Regimen: RC48-ADC: 2.0 mg/kg, intravenous drip, once every 2 weeks,4-6 cycles
Primary Outcome Measure Information:
Title
Pathological complete response rate (pCR)
Description
absence of invasive carcinoma in the breast and axillary lymph nodes, while residual ductal carcinoma in situ was accepted (ypT0orTisypN0).
Time Frame
At the end of Cycle 1 (each cycle is 14 days)
Secondary Outcome Measure Information:
Title
adverse effects
Description
Serious adverse effect occur within neoadjuvant chemotherapy
Time Frame
during the period of neadjuvant chemotherapy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Enrolled were ≥ 18 years of age and < 80 years of age
Female or male breast cancer
Patients with early or locally advanced breast cancer who are HER2-positive, have a tumor larger than 2 cm and/or have lymph node metastasis: HER2-positive is defined as 3 + by immunohistochemistry, or 2 + by immunohistochemistry, with a positive FISH test.
Left ventricular score ≥ 55%
ECOGPS score 0 or 1
Able to understand the test requirements, willing and able to comply with the test and follow-up procedures
Adequate organ function
Exclusion Criteria:
cardiac, hepatic, renal, or psychiatric disease history
History of other malignancy within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
RC48 for Neoadjuvant Chemotherapy of HER2 Positive Breast Cancer
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