HR+/HER2- Advanced and/or Metastatic Breast CancerPhase 2NCT05044988
A Study of HS-10342 in Chinese Patients With HR+/HER2- Advanced and/or Metastatic Breast Cancer
A Phase 2 study testing HS-10342 in people with HR+/HER2- Advanced and/or Metastatic Breast Cancer, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HR+/HER2- Advanced and/or Metastatic Breast Cancer
- What is being tested?
- HS-10342
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2021to 31 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- Abnormal liver and kidney functions that are known to affect drug metabolism and excretion:
- History of other primary malignancies.
- Participating in other clinical studies.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Being tested
- HS-10342
- Keywords
- Advanced and/or Metastatic Breast Cancer, HR+/HER2-, CDK4/6, HS-10342
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10342Drug
HS-10342 tablet once daily from Day 1 to 21 of a 28-day cycle
| Study group | Role | What they receive |
|---|---|---|
| HS-10342 | Experimental | 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. Receives: Drug: HS-10342 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 12 months
Secondary outcomes (4)
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.
Measured: From Date of the First Dose until Death Due to Any Cause (Up To 24 Months)
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.
Measured: From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 12 Months)
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.
Measured: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 24 Months)
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.
Measured: Disease Control Rate [DCR]) [ Time Frame: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 12 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start30 Sep 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HR+/HER2- Advanced and/or Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044988
- Sponsor's protocol ID
- HS-10342-201
- Status last verified
- Aug 2021
- First submitted
- 7 Sep 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05044988
- Acronym / sponsor ID
- HS-10342-201
- Keywords
- Advanced and/or Metastatic Breast Cancer, HR+/HER2-, CDK4/6, HS-10342
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HS-10342 | Experimental | Drug: HS-10342Each 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- Has received or is undergoing the following treatments:
- Abnormal liver and kidney functions that are known to affect drug metabolism and excretion:
- History of other primary malignancies.
- Participating in other clinical studies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-10342HS-10342 tablet once daily from Day 1 to 21 of a 28-day cycle | Drug | HS-10342 |
Primary outcome
Percentage of Participants With Complete Response (CR) or Partial Response (PR)（Objective response rate [ORR]）
Time frame: Up to approximately 12 months
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.
4 secondary outcomes
Overall Survival (OS)
Time frame: From Date of the First Dose until Death Due to Any Cause (Up To 24 Months)
Duration of Response (DOR)
Time frame: From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 12 Months)
Progression Free Survival (PFS)
Time frame: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 24 Months)
Percentage of Participants With CR, PR or SD
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HS-10342 in people with HR+/HER2- Advanced and/or Metastatic Breast Cancer, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Binghe Xu (87788826 ext. 010, xubinghe@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Complete Response (CR) or Partial Response (PR)（Objective response rate [ORR]） (time frame: Up to approximately 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.