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Study identifier: NCT06235931 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Breast Neoplasms  ·  Sponsor: Second Affiliated Hospital of Soochow University

PhaseNA
Planned participants34
Who can joinFemale, 65 Years to no upper limit
Healthy volunteersNo

About this study

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 …

This description comes directly from the study's public registry record.

Talk to the study team

Hui Wang  ·  13913501391  ·  whuisd@163.com

Always discuss trial participation with your own doctor first.

Locations (1)

The Second Affiliated Hospital of Soochow UniversitySuzhou, Jiangsu, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT06235931