Exemestane in Combination With Fulvestrant in Postmenopausal Women With Hormone Sensitive Advanced Breast Cancer
NCT ID: NCT00201864
Last Updated: 2018-07-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2005-09-30
2014-02-28
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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single-arm study
Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection
Exemestane
25 mg orally per day
Fulvestrant
250 mg IM starting on Day 8 and then every 28 days.
Interventions
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Exemestane
25 mg orally per day
Fulvestrant
250 mg IM starting on Day 8 and then every 28 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Metastatic or locally advanced breast cancer
* Hormonally responsive disease defined as estrogen (ER) and/ or progesterone receptor (PR) positive (\>10% staining by immunohistochemistry)
* Postmenopausal status
* No more than 1 prior chemotherapy for stage IV metastatic breast cancer allowed
* ECOG (Eastern Cooperative Oncology Group) performance status 0-2
* Adequate organ function
Exclusion Criteria
* Uncontrolled intercurrent illness including but not limited to:
* ongoing or active infection
* symptomatic congestive heart failure
* unstable angina pectoris
* cardiac arrhythmia
* myocardial infarction within the last 3 months
* psychiatric illness/social situations that would limit compliance with study
* Lymphangitic pulmonary disease; carcinomatous meningitis, bone marrow only metastases; and a rising tumor marker without any other site of metastatic disease.
* Presence of bleeding diathesis or coagulopathy, patients requiring coumadin
18 Years
FEMALE
No
Sponsors
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Pfizer
INDUSTRY
Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Ewa Mrozek, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University
Locations
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Ohio State University
Columbus, Ohio, United States
Countries
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References
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Mrozek E, Layman R, Ramaswamy B, Schaaf L, Li X, Ottman S, Shapiro CL. Phase II trial of exemestane in combination with fulvestrant in postmenopausal women with advanced, hormone-responsive breast cancer. Clin Breast Cancer. 2012 Apr;12(2):151-6. doi: 10.1016/j.clbc.2012.01.003.
Related Links
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Jamesline
Other Identifiers
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NCI-2011-03154
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-0494
Identifier Type: -
Identifier Source: org_study_id
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