Clinical trial NCT04556292: A Phase II Study to Assess the Efficacy and Safety of SC10914 in the Metastatic Breast Cancer Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer Metastatic
BRCA 1 Gene Mutation
BRCA 2 Gene Mutation
Lead sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2020-09-21
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Germline mutation in BRCA1 or BRCA2
2. Histologically or cytologically confirmed breast cancer with evidence of metastatic disease.
3. Prior therapy with an anthracycline and/or a taxane in either an adjuvant or metastatic setting
4. 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
5. 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 .
6. 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 .
7. 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.
8. ECOG performance status 0-1.
9. Adequate bone marrow, kidney and liver function

Exclusion Criteria:

1. Prior treatment with PARP inhibitor.
2. Patients with HER2 positive disease
3. Untreated and/or uncontrolled brain metastases
4. Known HIV (Human Immunodeficiency Virus) infection.
5. Persistent toxicities (≥CTCAE grade 2) caused by previous cancer therapy, excluding alopecia
6. Pregnant or breast feeding women

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Assessed up to a maximum of 30 months
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Assessed up to a maximum of 30 months
measure: Overall Survival (OS)
timeFrame: Assessed up to a maximum of 30 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: hu xichun, MD
role: PRINCIPAL_INVESTIGATOR
References: