Exemestane in Combination With Fulvestrant in Postmenopausal Women With Hormone Sensitive Advanced Breast Cancer
NCT00201864
ABOUT THIS STUDY
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- Proven breast cancer
- 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
-
- No prior Exemestane or Fulvestrant
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Exemestane in Combination With Fulvestrant in Postmenopausal Women With Hormone Sensitive Advanced Breast Cancer | |||
Official Title ICMJE | Phase II Trial of Exemestane (Aromasin) in Combination With Fulvestrant (Faslodex) in Postmenopausal Women With Hormone Sensitive Advanced Breast Cancer | |||
Brief Summary | The purpose of this trial is to evaluate time to progression in women with hormone responsive advanced breast cancer treated with a combination of exemestane and fulvestrant. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Breast Cancer | |||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: single-arm study
Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection Interventions:
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Publications * | Mrózek 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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 40 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | February 2014 | |||
Actual Primary Completion Date | June 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00201864 | |||
Other Study ID Numbers ICMJE | OSU-0494 NCI-2011-03154 ( Registry Identifier: Clinical Trial Reporting Program (CTRP) ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Ohio State University Comprehensive Cancer Center | |||
Study Sponsor ICMJE | Ohio State University Comprehensive Cancer Center | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | Ohio State University Comprehensive Cancer Center | |||
Verification Date | June 2018 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |