Study of Dalpiciclib and Endocrine Therapy for Treating Early Hormone Receptor-Positive, HER2-Negative Breast Cancer in Women

What this Trial Is About

Researchers are evaluating the effectiveness and safety of dalpiciclib combined with endocrine therapy as an additional treatment for patients with medium to high risk hormone receptor-positive, HER2-negative early breast cancer. This phase II, multi-center, open-label trial focuses on this specific group of breast cancer patients to better understand treatment outcomes and safety profiles. Participants will receive dalpiciclib, a CDK46 inhibitor taken orally at 100 mg daily, alongside endocrine therapy using fulvestrant or aromatase inhibitors. This treatment is given as an adjuvant therapy, meaning it is administered following surgery to reduce the risk of cancer returning. The study includes only one treatment group combining these therapies. During the trial, participants will be monitored for invasive disease-free survival over a period of up to three years after enrollment. Researchers will also observe disease-free survival and record any adverse events or serious adverse events from the start of treatment until one month after the last dose. Participants will undergo regular assessments to evaluate their health status and treatment effects throughout the study.

Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer