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NOT YET RECRUITING
NCT07005557
PHASE3

Chemo-free in Older (≥65) Node-Positive ER+/HER2- Breast Cancer

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

This study is a prospective, open-label, multicenter, randomized controlled Phase III clinical trial. Based on the use of CDK4/6 inhibitors in endocrine-sensitive luminal-type (ER+/HER2-) breast cancer, it aims to explore the possibility of chemotherapy exemption in elderly patients (aged \>65 years) with lymph node-positive, HR+/HER2- breast cancer.

Official title: Study Evaluating Node-positive, ER+/HER2- In Older (≥65 Years) Breast Cancer Patients for Chemotherapy Exemption: A Randomized, Open-label, Multicenter Phase III Clinical Trial

Key Details

Gender

FEMALE

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1244

Start Date

2025-06-15

Completion Date

2035-05-15

Last Updated

2025-06-05

Healthy Volunteers

No

Interventions

DRUG

Chemotherapy

Chemotherapy options at physician's discretion: TC, EC-T(wP), or capecitabine.

DRUG

CDK4/6 Inhibitor

All patients will receive CDK4/6 inhibitor (abemaciclib/ribociclib/dalpiciclib/palbociclib)

DRUG

Endocrine therapy

Endocrine therapy (letrozole/anastrozole/exemestane)