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

NCT06341894 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1163

Last updated 2024-04-02

No results posted yet for this study

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.

Conditions

  • Early Breast Cancer

Interventions

DRUG

Dalpiciclib

CDK4/6 inhibitor dalpiciclib, 100mg orally qd

DRUG

Endocrine therapy

Fulvestrant/AI

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-11-17
Primary Completion
2027-06-30
Completion
2029-06-30

Countries

  • China

Study Locations

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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 NCT06341894 on ClinicalTrials.gov