MedTrace Logo

Chemotherapy Omission in ER+/HER2- Breast Cancer With 1-3 Positive Lymph Nodes Receiving Extended Adjuvant Abemaciclib

NCT06341621 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1900

Last updated 2024-04-10

No results posted yet for this study

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

Conditions

Interventions

DRUG

3-year abemaciclib without chemo

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

DRUG

treatment of physician's choice

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

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Zhimin Shao, MD, PhD · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-04-02
Primary Completion
2027-02-25
Completion
2029-01-01

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 NCT06341621 on ClinicalTrials.gov