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ACTIVE NOT RECRUITING
NCT06637150
PHASE3

Dalpicilib-Enhanced Vs. Standard Endocrine Therapy in ER+ HER2- Early Breast Cancer

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

This study aims to conduct a randomized controlled clinical trial to compare the efficacy and safety of dalpicilib combined with endocrine therapy versus standard endocrine therapy in ER-positive, HER2-negative, lymph node-negative patients with risk factors, in order to further optimize the regimen for adjuvant endocrine therapy in breast cancer.

Official title: A Phase III Randomized Controlled Trial Comparing Dalpicilib-Enhanced Adjuvant Endocrine Therapy with Standard Adjuvant Endocrine Therapy in ER+ HER2- Lymph Node-Negative Early Breast Cancer with Risk Factors

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

1388

Start Date

2024-09-01

Completion Date

2030-09-30

Last Updated

2024-10-15

Healthy Volunteers

No

Conditions

Interventions

DRUG

Dalpicilib

Dalpicilib 100 mg once daily from day 1 to day 21, every 4 weeks, for a total of 3 years, in combination with endocrine therapy for 5 years.

DRUG

endocrine therapy

standard endocrine therapy

Locations (1)

breast cancer institute of Fudan University Cancer Hospital, shanghai, shanghai

Shanghai, China