A Prospective, Randomized, Controlled, Phase III Clinical Study on Hormone Receptor Positive HER2 Positive Breast Cancer of RCB1-2 After Neoadjuvant Treatment With Trastuzumab Combined With Parezumab

• Status: Recruiting
• Trial end date: 2028-11-01

Summary

Research background: Neratinib is an irreversible pan HER tyrosine kinase inhibitor, which belongs to one of tyrosine kinase inhibitors (TKI). In the non pCR HER2 positive breast cancer patients after neoadjuvant therapy, there is no study on macromolecular anti HER2 drugs combined with TKI drugs to treat HER2 positive breast cancer patients after neoadjuvant therapy. In addition, there is no prospective randomized controlled study results of trastuzumab combined with patuzumab versus trastuzumab combined with TKI drugs for HER2 positive breast cancer patients with RCBI-II after new adjuvant treatment. To sum up, this study is intended to design and evaluate the efficacy and safety of trastuzumab combined with nelatinib in the treatment of hormone receptor positive HER2 positive breast cancer RCBI-II patients after the new adjuvant treatment of trastuzumab combined with patouzumab.

Objective: This study was designed to evaluate the efficacy and safety of trestuzumab combined with nelatinib in the adjuvant treatment of breast cancer patients with hormone receptor positive HER2 positive RCB I-II after the neoadjuvant treatment of trestuzumab combined with partuzumab.

Trial design: Single center, randomized controlled phase III clinical study.

Study content: Study content: The qualified subjects will be randomly (1:1) treated with the following scheme:

Treatment plan:

Experimental group: Trastuzumab combined with nelatinib

Control group: Trastuzumab combined with Parstuzumab

Nilatinib: Take 240 mg (6 tablets) orally once a day, which can be taken with food every 21 days as a cycle. After surgery, it starts to be used together with trastuzumab, and stops the next cycle when trastuzumab treatment is completed.

Trastuzumab: loading dose 8mg/kg, maintenance dose 6mg/kg, intravenous infusion, once every three weeks, with a total of 18 cycles during the new adjuvant treatment.

Patuzumab: loading dose 840mg/kg, maintenance dose 420mg, intravenous infusion, once every three weeks, with a total of 18 cycles during the new adjuvant treatment.

Observation index: main index: Invasive disease free survival (IDFS) refers to the time from randomization to the first occurrence of local or distant disease recurrence or death.

Secondary indicators: 1. Disease free survival (DFS): refers to the time from randomization to disease recurrence or death due to disease progression.

2. Overall survival (OS): the time from randomization to death from any cause.

3. Distant disease free survival (DDFS): the time when no metastatic lesion was found in other places except the primary lesion after treatment.

4. Incidence and severity of adverse events

• Phase: Phase 3

Details

• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Treatments: Diphosphonates; Trastuzumab