NCT07101159View on ClinicalTrials.gov

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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

December 31, 2031

Study Completion Date

December 31, 2031

Conditions
Early Breast CancerAdjuvant TherapyHormone Receptor Positive / HER2-negative Breast Cancer
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.

All Listed Sponsors
lead

Fujian Cancer Hospital

OTHER_GOV