NCT05577923

Exploring Whether Disease-free Intervals Can Guide Endocrine Combined Targeted Therapy for ER+/HER2+ Advanced Breast Cancer (T-sunflower)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, single-arm, phase II clinical study for patients with ER+/HER2+ advanced breast cancer.

Detailed description

Patients with ER+/HER2+ advanced breast cancer are planned to be enrolled. Patients will receive first-line endocrine therapy combined with anti-HER2 therapy. The main purpose is to evaluate whether disease-free intervals can guide first-line endocrine combined targeted therapy for ER+/HER2+ advanced breast cancer.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Trastuzumab	8 mg/kg loading dose IV, then 6 mg/kg IV, every 3 weeks
DRUG	pyrotinib	Pyrotinib 320mg, PO daily, continuously
DRUG	Dalpiciclib	Dalpiciclib will be given at the dose of 125 mg po q.d. x 21 every 4 weeks
DRUG	fulvestrant	Fulvestrant will be given intramuscle at the dose of 500 mg every 4 weeks (with an additional 500 mg dose given two weeks after the initial dose.

Timeline

• Start date: 2022-11-01
• Primary completion: 2024-09-01
• Completion: 2026-03-01
• First posted: 2022-10-13
• Last updated: 2022-10-13

Locations

1 site across 1 country: China