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

NCT06637150 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1388

Last updated 2024-10-15

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2030-09-30
Completion
2030-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06637150 on ClinicalTrials.gov