NCT04856371

Study of CYH33 in Combination With Endocrine Therapy With or Without Palbociclib in Patients With HR+, HER2- Advanced Breast Cancer

A Multicenter, Open-label, Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CYH33 in Combination With Endocrine Therapy With or Without Palbociclib in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 228 (estimated)
• Sponsor: Haihe Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open-label, phase Ib study designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of CYH33 administered orally in combination with standard-of-care ET ± CDK4/6 inhibitor therapies for the treatment of locally advanced, recurrent or metastatic hormone-receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer. Patients will be enrolled in two stages, including dose exploration phase (Stage 1) and dose expansion phase (Stage 2) of each cohort.

Conditions

• Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	CYH33	Participants will receive oral CYH33 once daily on Days 1-28 of each 28-day cycle.
DRUG	Fulvestrant	Participants will receive fulvestrant 500 mg, administered intramuscularly on Days 1, 15 on Cycle 1 (28-day cycle) and Day 1 at each 28-day cycle thereafter.
DRUG	Letrozole	Participants will receive oral letrozole once daily continuous on Day 1-28 of each cycle.
DRUG	Palbociclib	Participants will receive palbociclib once daily continuous on Day 1-21 of each 28-day cycle.

Timeline

• Start date: 2021-04-01
• Primary completion: 2022-03-01
• Completion: 2022-12-01
• First posted: 2021-04-23
• Last updated: 2021-04-23