Breast Cancer, HER2-positive Breast Cancer
Conditions
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.
Interventions
DRUGRecombinant humanized anti-HER2 monoclonal antibody-MMAE coupling agent (RC48-ADC)
Regimen: RC48-ADC: 2.0 mg/kg, intravenous drip, once every 2 weeks,4-6 cycles
Sponsors
Xijing Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Enrolled were ≥ 18 years of age and \< 80 years of age 2. Female or male breast cancer 3. 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. 4. Left ventricular score ≥ 55% 5. ECOGPS score 0 or 1 6. Able to understand the test requirements, willing and able to comply with the test and follow-up procedures 7. Adequate organ function
Exclusion criteria
1. cardiac, hepatic, renal, or psychiatric disease history 2. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete response rate (pCR) | At the end of Cycle 1 (each cycle is 14 days) | absence of invasive carcinoma in the breast and axillary lymph nodes, while residual ductal carcinoma in situ was accepted (ypT0orTisypN0). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| adverse effects | during the period of neadjuvant chemotherapy | Serious adverse effect occur within neoadjuvant chemotherapy |
Outcome results
None listed