Fulvestrant 500mg in Patients With Advanced Breast Cancer
NCT ID: NCT02909361
Last Updated: 2022-04-20
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
500 participants
OBSERVATIONAL
2017-10-11
2022-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Fulvestrant
500 mg on days 0, 14, and 28, and every 28 days thereafter
Fulvestrant
500 mg on days 0, 14, and 28, and every 28 days thereafter
Interventions
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Fulvestrant
500 mg on days 0, 14, and 28, and every 28 days thereafter
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histologically confirmed positive oestrogen receptor status (ER positive) of primary breast cancer or metastatic tumour tissue, according to the local laboratory parameters.
3. Prior endocrine therapy for advanced disease was not permitted.
4. The prescription of the Fulvestant is clearly separated from the decision to include the subject in the NIS, and is part of normal medical practice. The recruitment of the patient to the study should be within 1 month of the first Fulvestant injection.
5. Provision of subject informed consent.
Exclusion Criteria
2. HER2 overexpression or gene amplification, ie, immunohistochemistry (IHC) 3+ or fluorescence in situ hybridisation (FISH)+, where appropriate.
3. Pervious regimen of endocrine therapy for advanced disease.
4. More than one regimen of chemotherapy for advanced disease.
5. Pregnancy and lactation.
6. Severe hepatic impairment.
18 Years
FEMALE
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Xichun Hu
Director of department of medical oncology
Principal Investigators
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Xichun Hu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan University Cancer Hospital
Shanghai, , China
Countries
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Other Identifiers
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Fudan BR2016-21
Identifier Type: -
Identifier Source: org_study_id
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