Prospective, Single-arm, Single-center Clinical Study of Darcilil Combined With AI and Pyrrotinib to Treat Elderly Patients With Advanced Triple-positive Breast Cancer

What this Trial Is About

Researchers are studying a treatment for elderly patients aged 65 and older with advanced triple-positive breast cancer. This cancer type is characterized by tumors that test positive for HER2, estrogen receptor, and progesterone receptor. The study aims to confirm the safety and effectiveness of a new combination therapy including Darcilide, pyrrotinib, and aromatase inhibitors (letrozole, anastrozole, or exemestane) for these patients who often have low physical status and poor tolerance for toxic chemotherapy. Participants will receive a combination treatment of Darcilide taken orally at 125 mg once daily for 21 days followed by 7 days off in 28-day cycles. They will also take an aromatase inhibitor daily and pyrrotinib starting at 240 mg orally once daily, with the dose potentially increasing to 320 mg if side effects are manageable. Treatment continues until disease progression, intolerable side effects, withdrawal of consent, or investigator decision. The study includes a screening period up to 28 days, followed by treatment and regular imaging assessments based on clinical routine and RECIST 1.1 criteria. During the study, participants will have safety checks, imaging evaluations, and follow-up visits including one 28 days after the last treatment. Safety follow-up continues until adverse events resolve or death. Efficacy follow-up continues until tumor progression, death, or consent withdrawal. Survival follow-up lasts until death, withdrawal, or the study's end date. Researchers will measure progression-free survival as the primary outcome over 29 months, along with overall survival, response rates, disease control, and duration of remission.

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