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NOT YET RECRUITING
NCT07826052
PHASE2

Chemotherapy Exemption in Elderly Women With Node-Positive ER+/HER2- Breast Cancer

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

This study is a prospective, open-label, multicenter, single-arm Phase II 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: A Prospective, Open-Label, Single-Arm Phase II Clinical Trial to Explore Chemotherapy Exemption in Elderly Women Aged 65 Years or Older With Lymph Node-Positive ER+/HER2- Breast Cancer

Key Details

Gender

FEMALE

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

494

Start Date

2026-09-15

Completion Date

2035-10-01

Last Updated

2026-09-17

Healthy Volunteers

No

Interventions

DRUG

CDK4/6 inhibitor

(abemaciclib/ribociclib/dalpiciclib/palbociclib)

DRUG

Endocrine Therapy (Optional)

Endocrine therapy (letrozole/anastrozole/exemestane)