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Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy for Early HR +/HER2- Breast Cancer: a Multicenter, Prospective Clinical Study
Sponsor: Fujian Cancer Hospital
Summary
This study is a multicenter, prospective, randomized, open-label clinical study to assess the efficacy and safety of endocrine combined with different doses and treatment duration of darisenatide adjuvant therapy in HR +/HER2- early breast cancer. The study planned to include 2000 HR +/HER2- early breast cancer patients who met the study criteria and were randomized in a 1:1 ratio to Column 1 and Column 2 stratified by nodal status (positive/negative), prior (neo) adjuvant chemotherapy (yes/no), and clinical/pathological stage (Stage II/III). Cohort 1 received dalcili 125 mg in combination with endocrine therapy for 2 years with dalcili; Cohort 2 received dalcili 100 mg in combination with endocrine therapy for 3 years with dalcili; treatment had to be discontinued until disease progression, intolerable adverse events, withdrawal of consent, or investigator judgment.
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2000
Start Date
2026-01-21
Completion Date
2032-06-30
Last Updated
2026-05-12
Healthy Volunteers
No
Conditions
Interventions
Dalpiciclib 125mg
Dalpiciclib: 125 mg, once daily, taken at approximately the same time every day, fasting 1 hour before and after taking the drug, for 21 consecutive days, followed by 7 days off, 28 days as a treatment cycle. It was administered for 2 years.
Dalpiciclib 100mg
Dalpiciclib: 100 mg, once daily, taken at approximately the same time every day, fasting 1 hour before and after taking the drug, for 21 consecutive days, followed by 7 days off, 28 days as a treatment cycle. It was administered for 3 years.
Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen
Endocrine therapy: endocrine therapy drugs selected by the investigator, including aromatase inhibitors (AIs), fulvestrant, tamoxifen, toremifene, etc.
Locations (2)
Fujian Cancer Hosptial
Fuzhou, Fujian, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China