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

NCT07005557 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1244

Last updated 2025-06-05

No results posted yet for this study

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.

Conditions

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)

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Zhiming Shao · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-15
Primary Completion
2030-05-15
Completion
2035-05-15

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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 NCT07005557 on ClinicalTrials.gov