A Phase II Study to Assess the Efficacy and Safety of SC10914 in the Metastatic Breast Cancer Patients
NCT ID: NCT04556292
Last Updated: 2020-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
78 participants
INTERVENTIONAL
2020-08-12
2022-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SC10914 group
SC10914
SC10914 400mg tid
Interventions
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SC10914
SC10914 400mg tid
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Jiangxi Qingfeng Pharmaceutical Co. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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hu xichun, MD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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wu han, MD
Role: CONTACT
Facility Contacts
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hu xichun, MD
Role: primary
Other Identifiers
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QF-SC10914-203
Identifier Type: -
Identifier Source: org_study_id
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