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NOT YET RECRUITING
NCT07101159
PHASE2

Dalpiciclib as Adjuvant Therapy for HR-positive/HER2-negative Early-stage Patients

Sponsor: Fujian Cancer Hospital

View on ClinicalTrials.gov

Summary

This study aims to evaluate the efficacy and safety of adjuvant endocrine therapy combined with dalpiciclib at different doses and durations in patients with hormone receptor (HR)-positive, HER2-negative early-stage breast cancer. It is a multicenter, prospective clinical study. All enrolled patients will receive either dalpiciclib 125 mg for 2 years or dalpiciclib 100 mg for 3 years, in combination with standard endocrine therapy. The primary endpoint is 3-year invasive disease-free survival (iDFS).

Official title: Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy in Early-stage HR-positive/HER2-negative Breast Cancer: a Multicenter, Prospective Clinical Study

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2025-09

Completion Date

2031-12

Last Updated

2025-08-03

Healthy Volunteers

No

Interventions

DRUG

Dalpiciclib

Dalpiciclib 100 mg orally, daily on days 1-21 of a 28-day cycle, for 3 years.

DRUG

Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)

Standard adjuvant endocrine therapy (e.g., tamoxifen or aromatase inhibitor), as per physician's choice.

DRUG

Dalpiciclib

Dalpiciclib 125 mg orally, daily on days 1-21 of a 28-day cycle, for 2 years.