NCT06481956

T-DM1 Combined With CDK4/6 Inhibitor Ribociclib

Phase II Clinical Study of Trastuzumab Emtansine (T-DM1) Combined With Cyclin-dependent Kinase 4/6 (CDK4/6) Inhibitor Ribociclib in the Treatment of Human Epidermal Growth Factor Receptor-2 (HER2)-Positive Advanced Breast Cancer

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Zheng Yabing · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To explore the efficacy and safety of T-DM1 combined with CDK4/6 inhibitor Ribociclib in the treatment of HER2-positive advanced breast cancer.

Detailed description

This is a multicenter, single-arm,Phase II clinical trial to explore the efficacy and safety of Trastuzumab Emtansine (T-DM1) combined with CDK4/6 inhibitor Ribociclib in the treatment of unresectable locally advanced or metastatic HER2-positive breast cancer.

Conditions

• HER2-positive Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	Ribociclib Oral Tablet	Patients with advanced breast cancer with at least one evaluable lesion and histologically proven invasive breast cancer were eligible for inclusion. Histopathologically positive for HER2 (IHC 3+, or IHC 2+ with fluorescence in situ hybridization (FISH) positive, either primary or metastatic. Patients with advanced breast cancer must have previously received first-line therapy or initial rescue therapy and have been treated with trastuzumab against HER2.

Timeline

• Start date: 2023-10-25
• Primary completion: 2027-01-10
• Completion: 2027-10-10
• First posted: 2024-07-01
• Last updated: 2024-07-01

Locations

1 site across 1 country: China