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

Jiangxi Qingfeng Pharmaceutical Co. Ltd.1 site in 1 country78 target enrollmentAugust 12, 2020

ConditionsBreast Cancer Metastatic BRCA 1 Gene Mutation BRCA 2 Gene Mutation

InterventionsSC10914

DrugsSC10914

Overview

Phase: Phase 2
Intervention: SC10914
Conditions: Breast Cancer Metastatic
Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Enrollment: 78
Locations: 1
Primary Endpoint: Objective Response Rate (ORR)
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 12, 2020

End Date

August 30, 2022

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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.
•ECOG performance status 0-
•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