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RECRUITING
NCT06341894
PHASE2

Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

Summary

The investigator conduct a phase II multi-center, open-label trial to evaluate efficacy and safety of dalpiciclib with endocrine therapy as adjuvant treatment in patients with medium /high risk hormone receptor-positive, HER2-negative Early Breast Cancer.

Official title: Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

1163

Start Date

2023-11-17

Completion Date

2029-06

Last Updated

2024-04-02

Healthy Volunteers

No

Interventions

DRUG

Dalpiciclib

CDK4/6 inhibitor dalpiciclib, 100mg orally qd

DRUG

Endocrine therapy

Fulvestrant/AI

Locations (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China