Back to resultsA Phase II Study to Assess the Efficacy and Safety of SC10914 in the Metastatic Breast Cancer Patients
Primary Purpose
Breast Cancer Metastatic, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SC10914
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer Metastatic
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 1.1.
- 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
Sites / Locations
- Fudan University Shanghai Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SC10914 group
Arm Description
Outcomes
Primary Outcome Measures
Objective Response Rate (ORR)
Using Independent Central Review Data Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1)
Secondary Outcome Measures
Progression-free Survival (PFS)
Using Independent Central Review According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1)
Overall Survival (OS)
from eligible until death due to any cause
Full Information
NCT ID
NCT04556292
First Posted
September 15, 2020
Last Updated
September 18, 2020
Sponsor
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04556292
Brief Title
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
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 12, 2020 (Actual)
Primary Completion Date
March 30, 2022 (Anticipated)
Study Completion Date
August 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Metastatic, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SC10914 group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SC10914
Intervention Description
SC10914 400mg tid
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
Using Independent Central Review Data Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1)
Time Frame
Assessed up to a maximum of 30 months
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
Using Independent Central Review According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1)
Time Frame
Assessed up to a maximum of 30 months
Title
Overall Survival (OS)
Description
from eligible until death due to any cause
Time Frame
Assessed up to a maximum of 30 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 1.1.
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
zhang qingsheng, MD,PhD
Phone
13913886090
Email
zhangqinsheng@sh-qingfeng.net
First Name & Middle Initial & Last Name or Official Title & Degree
wu han, MD
Phone
13770507990
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hu xichun, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hu xichun, MD
Phone
13811999030
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Phase II Study to Assess the Efficacy and Safety of SC10914 in the Metastatic Breast Cancer Patients
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