RC48 for Neoadjuvant Chemotherapy of HER2 Positive Breast Cancer

• Status: Not yet recruiting
• Trial end date: 2025-09-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xijing Hospital
• Treatments: Antibodies; Antibodies, Monoclonal; Trastuzumab

Criteria

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.