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RECRUITING
NCT07581834
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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.

DRUG

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