Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06996093
PHASE3

Chemotherapy Omission in HR-positive/HER2-negative Breast Cancer With Lymph Node Negative Disease Receiving Adjuvant Endocrine Therapy and CDK4/6 Inhibitor

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

This is a prospective, randomized, open-label, multicenter phase III study to explore chemotherapy omission in hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer with lymph node negative disease receiving adjuvant endocrine therapy and cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor.

Official title: Chemotherapy Omission in Hormone Receptor(HR)-Positive/Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer With Lymph Node Negative Disease Receiving Adjuvant Endocrine Therapy and Cyclin-dependent Kinases 4 and 6 (CDK4/6) Inhibitor

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

2508

Start Date

2025-06-02

Completion Date

2034-06-01

Last Updated

2025-05-30

Healthy Volunteers

No

Conditions

Interventions

DRUG

4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy

4 cycles of TC (docetaxel + cyclophosphamide) adjuvant chemotherapy

DRUG

aromatase inhibitor (± ovarian suppression) plus CDK4/6 inhibitor

aromatase inhibitor (± ovarian suppression) plus CDK4/6 inhibitor

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China