Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Fulvestrant

Letrozole

Palbociclib

Aromatase Inhibitors

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Protein Kinase Inhibitors

Participants will receive CYH33 in combination with a standard fixed dose of fulvestrant 500 mg.

Participants will receive CYH33 in combination with standard fixed dose of fulvestrant (500 mg) and palbociclib (125 mg).

Participants will receive CYH33 in combination with standard fixed dose of letrozole (2.5 mg) and palbociclib (125 mg)

Participants will receive oral CYH33 once daily on Days 1-28 of each 28-day cycle.

CYH33

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.

Participants will receive oral letrozole once daily continuous on Day 1-28 of each cycle.

Participants will receive palbociclib once daily continuous on Day 1-21 of each 28-day cycle.

Yong Yuan, MD

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.

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

Incidence rate of DLT in the first cycle (of 28 days).

Type, incidence, duration, severity and seriousness of adverse events (AEs).

Tumor objective response rate (ORR) assessed by RECIST v1.1

Clinical benefit rate (CBR) assessed by RECIST v1.1

Progression Free Survival (PFS) assessed by RECIST v1.1

Measure the variation of concentration in blood plasma as a function of time

Measure the minimum (trough) plasma concentration

Measure the maximum (peak) plasma concentration

Measure of time to reach maximum (peak) plasma concentration

Measure apparent total clearance(s) from plasma after administration

Measure apparent volume of distribution during terminal phase

Pre- and post-treatment PIK3CA changes in ctDNA samples.

Pre- and post-treatment PTEN changes in ctDNA samples.

Pre- and post-treatment KRAS changes in ctDNA samples.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of CYH33 in Combination With Endocrine Therapy With or Without Palbociclib in Patients With HR+, HER2- Advanced Breast Cancer	NCT04856371	Advanced Breast...	CYH33 Fulvestrant Letrozole Palbociclib	18 Years -	Haihe Biopharma Co., Ltd.
Study of CYH33 in Combination With Endocrine Therapy With or Without Palbociclib in Patients With HR+, HER2- Advanced Breast Cancer	NCT04856371	Advanced Breast...	CYH33 Fulvestrant Letrozole Palbociclib	18 Years -	Haihe Biopharma Co., Ltd.

Spots Global Cancer Trial Database for pik3ca mutant