CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 1,903 target
Drug / intervention
Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07019363
NCT07019363Phase 3RecruitingOn TrackUpdated 5mo ago

A Study on the Efficacy and Safety of CDK4/6 Inhibitors Combined With Standard Adjuvant Endocrine Therapy in High-Risk, HR+/HER2+ Early Breast Cancer Patients Who Have Completed Adjuvant Anti-HER2 Targeted Therapy"

Fudan University·interventional·Posted Jun 13, 2025·Updated Jan 21, 2026

In Brief

A Phase 3 clinical trial evaluating Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane) and Standard endocrine therapy combined with CDK4/6 Inhibitor for Breast Cancer and Adjuvant Therapy. Currently recruiting, targeting 1,903 participants across 1 site.

Detailed Summary

This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial. Building upon anti-HER2 targeted therapy combined with endocrine therapy, the addition of CDK4/6 inhibitors has demonstrated greater clinical benefits for advanced TPBC patients. This study aims to investigate the efficacy and safety of CDK4/6 inhibitor combination with standard adjuvant endocrine therapy in HR+/HER2+ early breast cancer patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 3Recruiting
20262027202820292030203120322033
First PostedJun 13, 2025
Enrollment StartJun 15, 2025
Primary CompletionMay 15, 2029
Study CompletionApr 15, 2033
TodayJul 1, 2026
Enrollment to primary: 3.9 yearsPosted 1.1 years agoPrimary completion in 2.9 years

Interventions

Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)drug

Standard endocrine therapy

Standard endocrine therapy combined with CDK4/6 Inhibitordrug

CDK4/6 inhibitor therapy for 2 years in combination with standard endocrine therapy