RC48 for Neoadjuvant Chemotherapy of HER2 Positive Breast Cancer

Breast Cancer Clinical Trial

Official title:

Phase II Clinical Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Coupling Agent (RC48-ADC) for Neoadjuvant Treatment of Breast Cancer With Positive HER2 Expression (Seraph)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05134519
• Other study ID #: XJLL-KY20212136
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: November 26, 2021
• Est. completion date: September 30, 2025

Study information

• Verified date: September 2021
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• HER2-positive Breast Cancer

Intervention

Drug:
• Recombinant 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	At the end of Cycle 1 (each cycle is 14 days)
Secondary	adverse effects	Serious adverse effect occur within neoadjuvant chemotherapy	during the period of neadjuvant chemotherapy