Overview

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

Status:
Not yet recruiting

Trial end date:
2022-12-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 1

Details

Lead Sponsor:

Haihe Biopharma Co., Ltd.

Treatments:

Fulvestrant
Letrozole
Palbociclib