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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04556292
Recruitment Status : Recruiting
First Posted : September 21, 2020
Last Update Posted : September 21, 2020
Sponsor:
Information provided by (Responsible Party):
Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Metastatic BRCA 1 Gene Mutation BRCA 2 Gene Mutation Drug: SC10914 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 12, 2020
Estimated Primary Completion Date : March 30, 2022
Estimated Study Completion Date : August 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: SC10914 group Drug: SC10914
SC10914 400mg tid


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Assessed up to a maximum of 30 months ]
    Using Independent Central Review Data Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1)


Secondary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: Assessed up to a maximum of 30 months ]
    Using Independent Central Review According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1)

  2. Overall Survival (OS) [ Time Frame: Assessed up to a maximum of 30 months ]
    from eligible until death due to any cause


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04556292


Contacts
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Contact: zhang qingsheng, MD,PhD 13913886090 zhangqinsheng@sh-qingfeng.net
Contact: wu han, MD 13770507990

Locations
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China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200000
Contact: hu xichun, MD    13811999030      
Sponsors and Collaborators
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Investigators
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Principal Investigator: hu xichun, MD Fudan University
More Information
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Responsible Party: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier: NCT04556292    
Other Study ID Numbers: QF-SC10914-203
First Posted: September 21, 2020    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases