CDK4/6 Inhibitor Intensification and Chemotherapy De-Escalation for Early-stage Luminal-HER2 Breast Cancer

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

1,500

Participants

Timeline

Start Date

October 7, 2025

Primary Completion Date

September 1, 2032

Study Completion Date

September 1, 2035

Conditions
Breast Cancer
Interventions
DRUG

CDK 4/6 inhibitor combined therapy (omit chemo)

CDK 4/6 inhibitor and endocrine therapy combined with Trastuzumab ( without chemotherapy)

DRUG

standard of care

four cycles of docetaxel and cyclophosphamide or four cycles of weekly paclitaxel Combined with Trastuzumab followed by standard endocrine therapy( aromatase inhibitors or tamoxifen,Ovarian function suppression agents may be added if premenopausal)

All Listed Sponsors
lead

Fudan University

OTHER