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Status unknownNCT04856371Updated Apr 23, 2021

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

A Phase 1 interventional study of CYH33 and Fulvestrant in Advanced Breast Cancer, sponsored by Haihe Biopharma Co., Ltd.. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-23.

Sponsored by Haihe Biopharma Co., Ltd. · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
228
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Advanced Breast Cancer

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Keywords

  • PIK3CA Mutant
  • Advanced Breast Cancer
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 228 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Haihe Biopharma Co., Ltd. is the lead sponsor of 20 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Main Inclusion Criteria:

  1. Provide informed consent voluntarily.
  2. Male and female patients ≥ 18 years of age.
  3. Patient must have a histologically or cytologically documented locally advanced, recurrent or metastatic breast cancer.
  4. In case of women, both premenopausal and postmenopausal patients can be enrolled in the study.
  5. Confirmed diagnosis of HR+, HER2- breast cancer.
  6. 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.
  7. Patient must have evidence of disease radiological progression after previous endocrine therapy, or other systemic therapy.
  8. Patient has measurable disease per RECIST v1.1.
  9. ECOG ≤ 1.
  10. Patient must have adequate organ and bone marrow function.

Main Exclusion Criteria:

  1. Previously received any anticancer therapy within 28 days or 5 times of half-lives prior to the first dose of the study treatment.
  2. Previously received treatment with any PI3Kα inhibitor, AKT inhibitor, or mTOR inhibitor.
  3. Radical radiation therapy within 4 weeks prior to the first dose of the study treatment.
  4. Patient with an established diagnosis of diabetes mellitus.
  5. Any other concurrent disease with potential risk of insulin resistance or current use of medication with potential risk of insulin resistance.
  6. Patient with clinically significant cardiovascular disease.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
228 participants (estimated)

Study arms

  • Experimental
    CYH33 + fulvestrant

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

    Drug: CYH33 · Drug: Fulvestrant

  • Experimental
    CYH33 + fulvestrant + palbociclib

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

    Drug: CYH33 · Drug: Fulvestrant · Drug: Palbociclib

  • Experimental
    CYH33 + letrozole + palbociclib

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

    Drug: CYH33 · Drug: Letrozole · Drug: Palbociclib

Interventions

  • DrugCYH33

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

  • DrugFulvestrant

    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.

  • DrugLetrozole

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

  • DrugPalbociclib

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

06

What researchers measure

Primary outcomes

  1. Dose Limiting Toxicities (DLT)

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

    Time frame: 28 days

Secondary outcomes

  1. Safety and tolerability

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

    Time frame: 30 months

  2. Preliminary efficacy-ORR

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

    Time frame: 30 months

  3. Preliminary efficacy-CBR

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

    Time frame: 30 months

  4. Preliminary efficacy-PFS

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

    Time frame: 30 months

  5. Pharmacokinetic measures - AUC

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

    Time frame: 20 months

  6. Pharmacokinetic measures - C trough

    Measure the minimum (trough) plasma concentration

    Time frame: 20 months

  7. Pharmacokinetic measures - Cmax

    Measure the maximum (peak) plasma concentration

    Time frame: 20 months

  8. Pharmacokinetic measures - Tmax

    Measure of time to reach maximum (peak) plasma concentration

    Time frame: 20 months

  9. Pharmacokinetic measures - CL/F

    Measure apparent total clearance(s) from plasma after administration

    Time frame: 20 months

  10. Pharmacokinetic measures - Vz/F

    Measure apparent volume of distribution during terminal phase

    Time frame: 20 months

  11. Assess downstream effects of PI3K pathway inhibition on blood glucose

    Pre- and post-treatment of blood glucose

    Time frame: 20 months

  12. Assess downstream effects of PI3K pathway inhibition on C peptide

    Pre- and post-treatment of C peptide

    Time frame: 20 months

  13. Assess the changes of biomarker-PIK3CA

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

    Time frame: 20 months

  14. Assess the changes of biomarker-PTEN

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

    Time frame: 20 months

  15. Assess the changes of biomarker-KRAS

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

    Time frame: 20 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04856371
Lead sponsor
Haihe Biopharma Co., Ltd.
Responsible party
Sponsor
First posted
Apr 23, 2021
Start date
Apr 2021 (estimated)
Primary completion
Mar 2022 (estimated)
Completion
Dec 2022 (estimated)
Last update
Apr 23, 2021

Study contacts

Yong Yuan, MD
Contact
yong.yuan@haihepharma.com
86 13820384005

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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