RC48 for Neoadjuvant Chemotherapy of HER2 Positive Breast Cancer

Last updated: November 14, 2021
Sponsor: Xijing Hospital
Overall Status: Active - Not Recruiting

Phase

2

Condition

Breast Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT05134519
XJLL-KY20212136
  • Ages 18-80
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 atumor 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 FISHtest.
  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 andfollow-up procedures
  7. Adequate organ function

Exclusion

Exclusion Criteria:

  1. cardiac, hepatic, renal, or psychiatric disease history
  2. History of other malignancy within the last 5 years, with the exception of adequatelytreated basal or squamous cell carcinoma of the skin or carcinoma in situ of thecervix.

Study Design

Total Participants: 20
Study Start date:
November 26, 2021
Estimated Completion Date:
September 30, 2025

Study 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.