RC48 for Neoadjuvant Chemotherapy of HER2 Positive Breast Cancer

Phase 2

Not yet recruiting

• Conditions: Breast Cancer; HER2-positive Breast Cancer
• Interventions: Drug: Recombinant humanized anti-HER2 monoclonal antibody-MMAE coupling agent (RC48-ADC)

• Registration Number: NCT05134519
• Lead Sponsor: Xijing Hospital

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.

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-23
• Study First Submitted QC: 2021-11-14
• Last Update Submitted: 2021-11-14
• Study Start: 2021-11-26
• Study First Posted: 2021-11-26
• Last Update Posted: 2021-11-26
• Primary Completion: 2024-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RC48 for neadjuvant chemotherapy	Recombinant humanized anti-HER2 monoclonal antibody-MMAE coupling agent (RC48-ADC)	RC48-ADC: 2.0 mg/kg, IV drip, Q2W

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
adverse effects	during the period of neadjuvant chemotherapy	Serious adverse effect occur within neoadjuvant chemotherapy