Study of Darsilide with Endocrine Therapy, Trastuzumab, and Patuzumab for Early or Locally Advanced HRHER2 Breast Cancer Before Surgery

What this Trial Is About

Researchers are evaluating a new combination treatment involving Darsilide with endocrine therapy, Trastuzumab, and Patuzumab for women with early or locally advanced hormone receptor-positive, HER2-positive breast cancer before surgery. This phase 2, single-arm, open clinical study aims to explore the effectiveness and safety of this new adjuvant therapy approach for these patients. Participants receive 150 mg of Darsilide once daily for 21 days followed by a 7-day break, forming a 28-day treatment cycle. Letrozole is given daily at 2.5 mg, with additional Trastuzumab and Patuzumab administered intravenously every three weeks or as a fixed-dose combination subcutaneous injection every three weeks. Patients undergo 8 cycles of this treatment before surgery. After two cycles, MRI scans evaluate tumor response those with partial response continue the same treatment, while others switch to a chemotherapy regimen. During the study, participants are closely monitored through breast MRI to assess tumor remission. Researchers measure the rate of complete pathological response after surgery as the primary outcome. Secondary outcomes include the occurrence of adverse events, objective tumor response rate, residual cancer burden, and survival rates up to five years after surgery. The study includes safety monitoring and follow-up as part of participant involvement throughout the treatment and evaluation periods.

Darsilide Combined With AI, Trastuzumab and Patuzumab in the Neoadjuvant Treatment of HR+/HER2+ Breast Cancer