CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 1,900 target
Drug / intervention
3-year abemaciclib without chemo +1 moredrug
Likely dose
3-year abemaciclib without chemo 100mgfrom 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/NCT06341621
NCT06341621Phase 3RecruitingOn TrackUpdated 26mo ago
CompareCT.gov

A Prospective, Randomized, Open-label, Multicenter Phase III Study to Explore Chemotherapy Omission in ER+/HER2-endocrine-sensitive Breast Cancer With 1-3 Positive Lymph Nodes Receiving Extended Adjuvant Abemaciclib

Fudan University·interventional·Posted Apr 2, 2024·Updated Apr 10, 2024

In Brief

A Phase 3 clinical trial evaluating 3-year abemaciclib without chemo and treatment of physician's choice for Breast Cancer. Currently recruiting, targeting 1,900 participants across 1 site.

Detailed Summary

This is a prospective, randomized, open-label, multicenter phase III study to explore chemotherapy omission in ER+/HER2-endocrine-sensitive breast cancer with 1-3 positive lymph nodes receiving extended (3 year) adjuvant abemaciclib

Study Details

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

Timeline

Phase 3Recruiting
20252026202720282029
First PostedApr 2, 2024
Enrollment StartApr 2, 2024
Primary CompletionFeb 25, 2027
Study CompletionJan 1, 2029
TodayJul 1, 2026
Enrollment to primary: 2.9 yearsPosted 2.2 years agoPrimary completion in 8 months

Interventions

3-year abemaciclib without chemodrug

aromatase inhibitors (± ovarian suppression) plus 3-year abemaciclib (100mg bid) without chemotherapy.

treatment of physician's choicedrug

treatment of physician's choice including whether to receive chemotherapy, chemotherapy regimen and endocrine therapy regimen.