Clinical trial NCT05044988: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: HR+/HER2- Advanced and/or Metastatic Breast Cancer
Keywords: Advanced and/or Metastatic Breast Cancer
HR+/HER2-
CDK4/6
HS-10342
Lead sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-09-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Have a diagnosis of Hormone Receptor Positive(HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer.
2. Recurrent, locally advanced, unresectable or metastatic breast cancer with disease progression following anti-estrogen therapy.
3. Prior treatment with chemotherapy regimens, No more than 2 prior chemotherapy regimens in the metastatic setting.
4. At least one extracranial measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1.
5. recovered from the acute effects of therapy with toxicity resolving to baseline or grade 1 except for residual alopecia and peripheral neuropathy.
6. Adequate function of major organs.

Exclusion Criteria:

1. Has received or is undergoing the following treatments:

   1. Currently receiving or have received any CDK4/6 inhibitors;
   2. Receiving/received antitumor therapy within 14 days or 5 half-lives, before the initial dose whichever is the longer;
   3. 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.;
   4. Major surgery within 4 weeks of the initial dose of study drug;
   5. 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;
2. Abnormal liver and kidney functions that are known to affect drug metabolism and excretion:
3. History of other primary malignancies.
4. Participating in other clinical studies.

Primary outcomes:
measure: Percentage of Participants With Complete Response (CR) or Partial Response (PR)（Objective response rate [ORR]）
timeFrame: Up to approximately 12 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From Date of the First Dose until Death Due to Any Cause (Up To 24 Months)
measure: Duration of Response (DOR)
timeFrame: From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 12 Months)
measure: Progression Free Survival (PFS)
timeFrame: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 24 Months)
measure: Percentage of Participants With CR, PR or SD
timeFrame: Disease Control Rate [DCR]) [ Time Frame: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 12 Months)
Other outcomes:
Locations:
Study officials:
References: