Status:
UNKNOWN
Study of CYH33 in Combination With Endocrine Therapy With or Without Palbociclib in Patients With HR+, HER2- Advanced Breast Cancer
Lead Sponsor:
Haihe Biopharma Co., Ltd.
Conditions:
Advanced Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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-...
Eligibility Criteria
Inclusion
- Main
- Provide informed consent voluntarily.
- Male and female patients ≥ 18 years of age.
- Patient must have a histologically or cytologically documented locally advanced, recurrent or metastatic breast cancer.
- In case of women, both premenopausal and postmenopausal patients can be enrolled in the study.
- Confirmed diagnosis of HR+, HER2- breast cancer.
- For Stage 1 dose exploration phase, patients with or without PIK3CA mutation may be enrolled; For Stage 2 dose expansion phase, patients with PIK3CA mutations are required.
- Patient must have evidence of disease radiological progression after previous endocrine therapy, or other systemic therapy.
- Patient has measurable disease per RECIST v1.1.
- ECOG ≤ 1.
- Patient must have adequate organ and bone marrow function.
- Main
Exclusion
- Previously received any anticancer therapy within 28 days or 5 times of half-lives prior to the first dose of the study treatment.
- Previously received treatment with any PI3Kα inhibitor, AKT inhibitor, or mTOR inhibitor.
- Radical radiation therapy within 4 weeks prior to the first dose of the study treatment.
- Patient with an established diagnosis of diabetes mellitus.
- Any other concurrent disease with potential risk of insulin resistance or current use of medication with potential risk of insulin resistance.
- Patient with clinically significant cardiovascular disease.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT04856371
Start Date
April 1 2021
End Date
December 1 2022
Last Update
April 23 2021
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