NCT07213206

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

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,500 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The investigators designed a phase III clinical trial involving hormone receptor-positive and HER2-positive stage I breast cancer patients. This trial aims to evaluate the efficacy and safety of a treatment regimen combining CDK4/6 inhibitors, endocrine therapy, and anti-HER2 therapy compared with the traditional approach of chemotherapy combined with anti-HER2 therapy.

Detailed description

For patients with hormone receptor-positive and HER2-positive breast cancer, the NCCN guidelines recommend that those with tumors larger than 1 cm or positive lymph nodes should receive standard adjuvant therapy comprising chemotherapy combined with targeted and endocrine therapy. In contrast, for patients with tumors smaller than 1 cm and negative lymph nodes, endocrine therapy alone or in combination with targeted therapy and chemotherapy may be considered. Therefore, in patients with stage I hormone receptor-positive and HER2-positive breast cancer, it remains unclear whether chemotherapy can be omitted by intensifying endocrine therapy through the addition of CDK4/6 inhibitors, particularly considering the intrinsic therapeutic efficacy of endocrine agents and their potential synergistic interaction with anti-HER2 therapy. To further minimize treatment-related toxicity and identify the optimal adjuvant treatment strategy for patients with HER2-positive stage I breast cancer, the investigators designed a phase III clinical trial involving hormone receptor-positive and HER2-positive stage I breast cancer patients. This trial aims to evaluate the efficacy and safety of a treatment regimen combining CDK4/6 inhibitors, endocrine therapy, and anti-HER2 therapy compared with the traditional approach of chemotherapy combined with anti-HER2 therapy.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2025-10-07
• Primary completion: 2032-09-01
• Completion: 2035-09-01
• First posted: 2025-10-08
• Last updated: 2025-10-08