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Trial Title:
RC48-ADC in HER2-low Advanced Breast Cancer
NCT ID:
NCT05831878
Condition:
Advanced Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Disitamab vedotin
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Disitamab vedotin
Description:
2.0mg/kg, iv, day1, every 2 weeks
Arm group label:
RC48-ADC
Other name:
RC48-ADC
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.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Address:
City:
Shanghai
Zip:
200127
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenjin Yin
Phone:
86(21)68385569
Email:
yinwenjin@renji.com
Start date:
May 4, 2023
Completion date:
August 2026
Lead sponsor:
Agency:
RenJi Hospital
Agency class:
Other
Source:
RenJi Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05831878
