Back to resultsA Study of HS-10342 in Chinese Patients With HR+/HER2- Advanced and/or Metastatic Breast Cancer
Primary Purpose
HR+/HER2- Advanced and/or Metastatic Breast Cancer
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
HS-10342
Sponsored by
About this trial
This is an interventional treatment trial for HR+/HER2- Advanced and/or Metastatic Breast Cancer focused on measuring Advanced and/or Metastatic Breast Cancer, HR+/HER2-, CDK4/6, HS-10342
Eligibility Criteria
Inclusion Criteria:
- Have a diagnosis of Hormone Receptor Positive(HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer.
- Recurrent, locally advanced, unresectable or metastatic breast cancer with disease progression following anti-estrogen therapy.
- Prior treatment with chemotherapy regimens, No more than 2 prior chemotherapy regimens in the metastatic setting.
- At least one extracranial measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1.
- recovered from the acute effects of therapy with toxicity resolving to baseline or grade 1 except for residual alopecia and peripheral neuropathy.
- Adequate function of major organs.
Exclusion Criteria:
Has received or is undergoing the following treatments:
- Currently receiving or have received any CDK4/6 inhibitors;
- Receiving/received antitumor therapy within 14 days or 5 half-lives, before the initial dose whichever is the longer;
- Radiotherapy with a limited field of radiation for palliation within 14 days of the initial dose of study drug, or received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 28 days of the initial dose.;
- Major surgery within 4 weeks of the initial dose of study drug;
- Brain metastases unless asymptomatic, stable, and not requiring steroids for at least 2 weeks prior to start of study treatment. Meningeal or brainstem metastases. Spinal cord compression;
- Abnormal liver and kidney functions that are known to affect drug metabolism and excretion:
- History of other primary malignancies.
- Participating in other clinical studies.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HS-10342
Arm Description
Each subject will receive repeat doses (C1, C2…) for 28-day cycles. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria is met.
Outcomes
Primary Outcome Measures
Percentage of Participants With Complete Response (CR) or Partial Response (PR)（Objective response rate [ORR]）
ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.
Secondary Outcome Measures
Overall Survival (OS)
OS defined as the time from first dose date to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.
Duration of Response (DOR)
DOR was the time from the date of first evidence of CR or PR to the date of objective progression or the date of death due to any cause, whichever is earlier.
Progression Free Survival (PFS)
PFS defined as the time from the first day of therapy to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
Percentage of Participants With CR, PR or SD
Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions.
Full Information
NCT ID
NCT05044988
First Posted
September 7, 2021
Last Updated
September 7, 2021
Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05044988
Brief Title
A Study of HS-10342 in Chinese Patients With HR+/HER2- Advanced and/or Metastatic Breast Cancer
Official Title
A Single-arm, Open-label, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of HS-10342 in Previously Treated Patients With Hormone Receptor Positive and Human Epidermal Growth Factor Receptor 2 Negative Advanced and/or Metastatic Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 30, 2021 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
HS-10342 is a selective CDK4/6 kinase inhibitor. This study is conducted to evaluate the safety and efficacy of HS-10342 at repeated doses.
Detailed Description
HS-10342-201 is a single- arm, open- label, multicenter, phase 2 study in patients with hormone receptor positive (HR positive), human epidermal growth factor receptor 2 negative (HER2 negative) advanced and/or metastatic breast cancer who have had disease progression after endocrine therapy. The efficacy is evaluated as monotherapy, and the primary endpoint is ORR.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HR+/HER2- Advanced and/or Metastatic Breast Cancer
Keywords
Advanced and/or Metastatic Breast Cancer, HR+/HER2-, CDK4/6, HS-10342
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HS-10342
Arm Type
Experimental
Arm Description
Each subject will receive repeat doses (C1, C2…) for 28-day cycles. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria is met.
Intervention Type
Drug
Intervention Name(s)
HS-10342
Intervention Description
HS-10342 tablet once daily from Day 1 to 21 of a 28-day cycle
Primary Outcome Measure Information:
Title
Percentage of Participants With Complete Response (CR) or Partial Response (PR)（Objective response rate [ORR]）
Description
ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.
Time Frame
Up to approximately 12 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS defined as the time from first dose date to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.
Time Frame
From Date of the First Dose until Death Due to Any Cause (Up To 24 Months)
Title
Duration of Response (DOR)
Description
DOR was the time from the date of first evidence of CR or PR to the date of objective progression or the date of death due to any cause, whichever is earlier.
Time Frame
From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 12 Months)
Title
Progression Free Survival (PFS)
Description
PFS defined as the time from the first day of therapy to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
Time Frame
From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 24 Months)
Title
Percentage of Participants With CR, PR or SD
Description
Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions.
Time Frame
Disease Control Rate [DCR]) [ Time Frame: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 12 Months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have a diagnosis of Hormone Receptor Positive(HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer.
Recurrent, locally advanced, unresectable or metastatic breast cancer with disease progression following anti-estrogen therapy.
Prior treatment with chemotherapy regimens, No more than 2 prior chemotherapy regimens in the metastatic setting.
At least one extracranial measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1.
recovered from the acute effects of therapy with toxicity resolving to baseline or grade 1 except for residual alopecia and peripheral neuropathy.
Adequate function of major organs.
Exclusion Criteria:
Has received or is undergoing the following treatments:
Currently receiving or have received any CDK4/6 inhibitors;
Receiving/received antitumor therapy within 14 days or 5 half-lives, before the initial dose whichever is the longer;
Radiotherapy with a limited field of radiation for palliation within 14 days of the initial dose of study drug, or received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 28 days of the initial dose.;
Major surgery within 4 weeks of the initial dose of study drug;
Brain metastases unless asymptomatic, stable, and not requiring steroids for at least 2 weeks prior to start of study treatment. Meningeal or brainstem metastases. Spinal cord compression;
Abnormal liver and kidney functions that are known to affect drug metabolism and excretion:
History of other primary malignancies.
Participating in other clinical studies.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Binghe Xu
Phone
87788826
Ext
010
Email
xubinghe@medmail.com.cn
12. IPD Sharing Statement
Learn more about this trial
A Study of HS-10342 in Chinese Patients With HR+/HER2- Advanced and/or Metastatic Breast Cancer
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