Study of Dalpiciclib with Endocrine Therapy in Women with Early HRHER2- Breast Cancer to Evaluate Safety and Effectiveness

What this Trial Is About

Researchers are evaluating the effectiveness and safety of dalpiciclib combined with endocrine therapy for women with early hormone receptor-positive HR and HER2-negative breast cancer. This phase 2, multicenter, randomized, open-label clinical study plans to enroll 2000 women, comparing two different doses and treatment durations of dalpiciclib alongside endocrine therapy. The studys goal is to understand how these treatments affect disease-free survival and overall outcomes in this patient group. Participants are randomly assigned to one of two groups one receives 125 mg of dalpiciclib daily for 2 years, and the other receives 100 mg daily for 3 years. Both groups take the drug in 28-day cycles, with 21 days on treatment followed by 7 days off, alongside endocrine therapy drugs selected by the investigator such as aromatase inhibitors, fulvestrant, tamoxifen, or toremifene. Treatment continues until disease progression, unacceptable side effects, withdrawal, or investigator decision. During the study, participants will have regular assessments including evaluations every 3 months in the first year and every 6 months in the second and third years to monitor patient-reported outcomes. The primary outcome is 3-year invasive disease-free survival, with secondary outcomes including distant disease-free survival, overall survival, and safety monitoring up to 30 days after treatment ends. Participants will be closely followed to assess treatment effects and side effects throughout the study duration.

Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy for Early HR +/HER2- Breast Cancer: a Multicenter, Prospective Clinical Study