A Clinical Study of Darcilil Combined With AI Combined With Pyrrotinib in the Treatment of TPBC - Trial NCT06235931

Timeline & Enrollment

Primary Outcome

Progression Free Survival

Summary

Elderly patients with advanced triple-positive breast cancer have the characteristics of low
 physical status and poor treatment tolerance. Therefore, such patients are often unable to
 tolerate more toxic chemotherapy regimen, and it is particularly important to choose a highly
 effective and low-toxic treatment regimen. However, few studies have paid attention to the
 treatment of such patients in the past.
 
 Pyrrotinib is a small molecule, irreversible, panerbb receptor tyrosine kinase inhibitor,
 which was independently developed by our country and has shown excellent efficacy in
 second-line anti-HER2 treatment of breast cancer, and has become the second-line standard
 treatment choice for advanced HER2-positive breast cancer. In addition, PHILA study results
 showed that the mPFS of pyrrotinib group reached 24 months. Compared with the control group,
 the duration of 10 months was significantly extended, indicating the significant efficacy of
 pyrrotinib in the first-line treatment of advanced HER2-positive breast cancer.
 
 Darsili is a CDK4/6 inhibitor independently developed in China, which has been reconstructed
 and optimized in molecular structure, and has become a new CDK4/6 inhibitor with more
 powerful modification by introducing piperidine structure through replacement of classical
 electronic and other panbody. The results of DAWNA-2 study indicated that the mPFS of Dalsily
 combined AI group reached 30.6 months, which was significantly longer than 18.2 months of the
 control group, and was the longest in similar studies.
 
 MUKDEN01 study, for the first time, tried the efficacy of pyrrotinib + letrozole + Dalsily
 regimen in the new adjuvant therapy of TPBC patients, and the results showed that ORR reached
 87.4%, CR rate was 30.4%, and pCR rate was 35.4%. Therefore, to further confirm the efficacy
 and safety of this protocol in elderly patients with advanced triple positive breast cancer,
 we intend to conduct this study. This is a prospective, single-arm, single-center clinical
 trial in which participants were treated with darcilide +AI
 (letrozole/anastrozole/exemestane) + pyrrotinib until disease progression, toxicity became
 intolerable, informed consent was withdrawn, or investigator judgment required
 discontinuation. The successful development of this study provides a new direction for the
 first-line treatment of elderly advanced triple-positive breast cancer.

ICD-10 Classifications