RecruitingPhase 2NCT07581834

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

Enrollment

2,000 participants

Start Date

Jan 21, 2026

Study Type

INTERVENTIONAL

Conditions

Breast Neoplasms Breast Diseases CDK4/6 Inhibitor HR+/HER2- Breast Cancer Dalpiciclib Endocrine Breast Diseases

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Dalpiciclib 100mg, a drug called Dalpiciclib 125mg, and others for people with breast diseases, breast neoplasms, and other related conditions. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDalpiciclib 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.

DRUGDalpiciclib 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.

DRUGEndocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen

Endocrine therapy: endocrine therapy drugs selected by the investigator, including aromatase inhibitors (AIs), fulvestrant, tamoxifen, toremifene, etc.