A Phase II Study to Assess the Efficacy and Safety of SC10914 in the Metastatic Breast Cancer Patients

Study Overview
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Brief Summary
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This open label, multi-centre phase II study will assess the efficacy and safety of single agent SC10914 in metastatic breast cancer patients with gBRCA 1/2 mutations.

Official Title
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A Phase 2, Open-Label, Multi-Center Study of SC10914 in Germline BRCA Mutation Subjects With Locally Advanced and/or Metastatic Breast Cancer, Who Have Received More Than 2 Prior Chemotherapy Regimens for Metastatic Disease

Conditions
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Breast Cancer Metastatic, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation

Intervention / Treatment
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* Drug: SC10914


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Germline mutation in BRCA1 or BRCA2 Histologically or cytologically confirmed breast cancer with evidence of metastatic disease. Prior therapy with an anthracycline and/or a taxane in either an adjuvant or metastatic setting Patients who have received platinum (cisplatin or carboplatin, either as monotherapy or in combination) for advanced breast cancer are eligible to enter the study provided platinum-free interval at least 6 months (time from last dose of platinum chemotherapy to disease progression Patients who have received platinum as potentially curative treatment for a prior cancer (e.g. ovarian cancer) or as adjuvant/neoadjuvant treatment for breast cancer are eligible provided at least 12 months have elapsed between the last dose of platinum-based treatment and eligible . Patients with estrogen and/or progesterone receptor-positive disease must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy . At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by CT (MRI where CT is contraindicated) and is suitable for repeated assessment as per RECIST 1.1. ECOG performance status 0-1. Adequate bone marrow, kidney and liver function Exclusion Criteria: Prior treatment with PARP inhibitor. Patients with HER2 positive disease Untreated and/or uncontrolled brain metastases Known HIV (Human Immunodeficiency Virus) infection. Persistent toxicities (≥CTCAE grade 2) caused by previous cancer therapy, excluding alopecia Pregnant or breast feeding women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SC10914 group<br> | Drug: SC10914<br>* SC10914 400mg tid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) | Using Independent Central Review Data Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) | Assessed up to a maximum of 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival (PFS) | Using Independent Central Review According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) | Assessed up to a maximum of 30 months | 
| Overall Survival (OS) | from eligible until death due to any cause | Assessed up to a maximum of 30 months |