RC48 for Neoadjuvant Chemotherapy of HER2 Positive Breast Cancer

Xijing Hospital20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer HER2-positive Breast Cancer

Interventions

Recombinant humanized anti-HER2 monoclonal antibody-MMAE coupling agent (RC48-ADC)DRUG

Regimen: RC48-ADC: 2.0 mg/kg, intravenous drip, once every 2 weeks,4-6 cycles

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).

Time frame: At the end of Cycle 1 (each cycle is 14 days)

Secondary Outcomes

adverse effects

Serious adverse effect occur within neoadjuvant chemotherapy

Time frame: during the period of neadjuvant chemotherapy

Data from ClinicalTrials.gov

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