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
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 20
- Primary Endpoint
- Percentage of Participants With Complete Response (CR) or Partial Response (PR)（Objective response rate [ORR]）
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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.
Arms & Interventions
HS-10342
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: HS-10342 (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Overall Survival (OS)(From Date of the First Dose until Death Due to Any Cause (Up To 24 Months))
- Percentage of Participants With CR, PR or SD(Disease Control Rate [DCR]) [ Time Frame: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 12 Months))
- Duration of Response (DOR)(From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 12 Months))
- Progression Free Survival (PFS)(From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 24 Months))