Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen for 2.5 to 3 Years Followed By Exemestane (TEAM)
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00036270
First received: May 8, 2002
Last updated: March 27, 2012
Last verified: March 2012
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Purpose
To compare the effects of exemestane for 5 years versus tamoxifen and exemestane given sequentially over 5 years in the adjuvant treatment of postmenopausal women with early breast cancer.
This Pfizer sponsored trial is part of an international collaboration of investigators conducting 7 similar yet independent studies in 9 countries. This study is designed to be part of the larger TEAM trial where the data from these 7 studies will be combined. A pre-specified analysis of the pooled data will be conducted.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Neoplasms |
Drug: exemestane (Aromasin) Drug: tamoxifen + exemestane |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen For 2.5- 3 Years Followed By Exemestane (Aromasin) For A Total Of 5 Years As Adjuvant Therapy For Postmenopausal, Receptor Positive, Node Negative or Node Positive Breast Cancer Patients |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 2.75 Years [ Time Frame: Baseline (Month 0) up to 2.75 years ] [ Designated as safety issue: No ]Number of events (disease relapse or death) to time of observation for DFS. DFS defined as time from randomization to earliest documentation of disease relapse or death from any cause in postmenopausal, receptor positive, node negative or node positive breast cancer patients for adjuvant treatment with exemestane compared with adjuvant tamoxifen therapy at 2.75 years. Disease relapse: primary tumor recurrence (locoregional or distant) and ipsilateral or contralateral breast cancer (CBC). Intercurrent death: death without disease relapse.
- Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 5 Years [ Time Frame: Baseline (Month 0) up to 5 years ] [ Designated as safety issue: No ]Number of events (disease relapse or death) to time of observation for DFS. DFS defined as time from randomization to earliest documentation of disease relapse or death from any cause in postmenopausal, receptor positive, node negative or node positive breast cancer patients for adjuvant treatment with exemestane compared with adjuvant tamoxifen therapy at 5 years. Disease relapse: primary tumor recurrence (locoregional or distant) and ipsilateral or contralateral breast cancer (CBC). Intercurrent death: death without disease relapse.
Secondary Outcome Measures:
- Number of Events for Overall Survival (OS) [ Time Frame: Baseline (Month 0) up to 5 years ] [ Designated as safety issue: No ]Number of events (death) to time of observation for OS. OS is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.
- Time to New Primary Breast Cancers [ Time Frame: Baseline (Month 0) up to 5 years ] [ Designated as safety issue: No ]New primary breast cancers were defined as events of ipsilateral/contralateral breast cancer (CBC).
- Number of Events for Time to Relapse [ Time Frame: Baseline (Month 0) up to 5 years ] [ Designated as safety issue: No ]Number of events to time of observation for relapse. Relapse is defined as all recurrences of the primary tumor (loco-regional and distant recurrence), second primary breast cancer, contralateral breast cancer.
- Number of Participants With New Primary Non-breast Cancers [ Time Frame: Baseline (Month 0) up to 5 years ] [ Designated as safety issue: No ]Number of participants with new primary non-breast cancers which included colorectal cancer, lung cancer, endometrial cancer, ductal carcinoma in situ (DCIS) and other primary cancer types.
| Enrollment: | 9779 |
| Study Start Date: | August 2001 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: exemestane |
Drug: exemestane (Aromasin)
exemestane, orally, 25 mg, for 5 years
Other Name: aromasin
|
| Experimental: tamoxifen + exemestane |
Drug: tamoxifen + exemestane
tamoxifen, 20 mg, orally, daily, 2-3 years; followed by exemestane, orally, 25 mg, for a total of 5 years of therapy
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically/cytologically confirmed adenocarcinoma of the breast, followed by adequate surgical resection and/or radiotherapy, and/or adjuvant chemotherapy, if indicated.
- Stage T1-3 N0-2 Mo, Any TNM stage BC for whom adjuvant hormonal therapy is being considered.
Exclusion Criteria:
- Those patients not deemed to have had potentially curative primary surgical treatment or one of the following criteria:
- Inflammatory breast cancer
- Histologically positive supraclavicular nodes
- Ulceration/infiltration of local skin metastasis
- Neoadjuvant chemotherapy
- Ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) without invasion
- ER and PR negative primary tumor or ER/PR unknown status.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00036270
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| United States, Alabama | |
| Pfizer Investigational Site | |
| Bessemer, Alabama, United States, 35022 | |
| Pfizer Investigational Site | |
| Birmingham, Alabama, United States, 35211 | |
| Pfizer Investigational Site | |
| Birmingham, Alabama, United States, 35213 | |
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| Birmingham, Alabama, United States, 35235 | |
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| Birmingham, Alabama, United States, 35209 | |
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| Birmingham, Alabama, United States, 35205 | |
| United States, Arizona | |
| Pfizer Investigational Site | |
| Flagstaff, Arizona, United States, 86001 | |
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| Green Valley, Arizona, United States, 85614 | |
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| Oro Valley, Arizona, United States, 85737 | |
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| Phoenix, Arizona, United States, 85012 | |
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| Safford, Arizona, United States, 85546 | |
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| Scottsdale, Arizona, United States, 85258 | |
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| Sedona, Arizona, United States, 86336 | |
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| Tucson, Arizona, United States, 85712 | |
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| Tucson, Arizona, United States, 85745 | |
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| Tucson, Arizona, United States, 85710 | |
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| Tuscon, Arizona, United States, 85704 | |
| United States, Arkansas | |
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| North Little Rock, Arkansas, United States, 72117 | |
| United States, Colorado | |
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| Aurora, Colorado, United States, 80012 | |
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| Boulder, Colorado, United States, 80303 | |
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| Colorado Springs, Colorado, United States, 80909 | |
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| Denver, Colorado, United States, 80218 | |
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| Denver, Colorado, United States, 80220 | |
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| Fort Collins, Colorado, United States, *0524 | |
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| Lakewood, Colorado, United States, 80228 | |
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| Lone Tree, Colorado, United States, 80124 | |
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| Longmont,, Colorado, United States, 80501 | |
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| Pueblo, Colorado, United States, 81008 | |
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| Thornton, Colorado, United States, 80260- | |
| United States, Florida | |
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| Clearwater, Florida, United States, 33761 | |
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| Hudson,, Florida, United States, 34667 | |
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| Jacksonville, Florida, United States, 32207 | |
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| Jacksonville, Florida, United States, 32204 | |
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| Lauderhill, Florida, United States, 33319 | |
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| Melbourne, Florida, United States, 32901 | |
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| New Port Richey, Florida, United States, 34655 | |
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| Ocala, Florida, United States, 34474 | |
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| Orange Park, Florida, United States, 32073 | |
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| Palatka, Florida, United States, 32177 | |
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| Plantation, Florida, United States, 33324 | |
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| St Augustine, Florida, United States, 32086 | |
| United States, Illinois | |
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| Alton,, Illinois, United States, 62002 | |
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| Arlington Heights, Illinois, United States, �60005 | |
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| Niles, Illinois, United States, 60714 | |
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| Winfield, Illinois, United States, 60190 | |
| United States, Indiana | |
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| Carmel, Indiana, United States, 46032 | |
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| Fishers, Indiana, United States, 46037 | |
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| Greenfield, Indiana, United States, 46140 | |
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| Indianapolis, Indiana, United States, 46219 | |
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| Indianapolis,, Indiana, United States, 46227 | |
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| Shelbyville, Indiana, United States, 46176 | |
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| Terre Haute, Indiana, United States, 47802 | |
| United States, Iowa | |
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| Cedar Rapids, Iowa, United States, 52403 | |
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| Kansas City, Kansas, United States, 66112 | |
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| Shawnee Mission, Kansas, United States, 66204 | |
| United States, Maryland | |
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| Westminster, Maryland, United States, 21157 | |
| United States, Massachusetts | |
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| North Adams, Massachusetts, United States, 01247 | |
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| Pittsfield, Massachusetts, United States, 01201 | |
| United States, Minnesota | |
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| Burnsville, Minnesota, United States, 55337 | |
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| Edina, Minnesota, United States, 55435-2150 | |
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| Maplewood, Minnesota, United States, 55109 | |
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| St. Paul, Minnesota, United States, 55102-2389 | |
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| Woodbury,, Minnesota, United States, 55125 | |
| United States, Missouri | |
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| Columbia, Missouri, United States, 65201 | |
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| Kansas City, Missouri, United States, 64131 | |
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| Kansas City, Missouri, United States, 64154 | |
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| Kansas City, Missouri, United States, 64111 | |
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| Lee's summit, Missouri, United States, 29307 | |
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| Lee's Summit, Missouri, United States, 64064 | |
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| St. Louis, Missouri, United States, 63136 | |
| United States, Nevada | |
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| Las Vegas, Nevada, United States, 89128 | |
| United States, New Mexico | |
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| Santa Fe, New Mexico, United States, 87505 | |
| United States, New York | |
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| Albany, New York, United States, 12206 | |
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| Albany,, New York, United States, 12208 | |
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| Amsterdam,, New York, United States, 12010 | |
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| Brockport, New York, United States, 14420 | |
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| Canandaigua, New York, United States, 14424 | |
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| Geneva, New York, United States, 14456 | |
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| Hudson, New York, United States, 12534 | |
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| Latham, New York, United States, 12110-0610 | |
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| Rexford,, New York, United States, 12148 | |
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| Troy,, New York, United States, 12180 | |
| United States, North Carolina | |
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| Asheville, North Carolina, United States, 28801 | |
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| Cary, North Carolina, United States, 27518 | |
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| Durham, North Carolina, United States, 27704 | |
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| Elizabeth City, North Carolina, United States, 27909 | |
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| Hickory, North Carolina, United States, 28602 | |
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| Kernersville, North Carolina, United States, 27284 | |
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| Lexington, North Carolina, United States, 27295 | |
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| Raleigh, North Carolina, United States, 27614 | |
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| Raleigh, North Carolina, United States, 27607 | |
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| Seneca, North Carolina, United States, 29672 | |
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| Winston-salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
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| Kettering, Ohio, United States, 45409 | |
| United States, Oklahoma | |
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| Bartlesville, Oklahoma, United States, 74006 | |
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| Noman, Oklahoma, United States, 73071 | |
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| Oklahoma City, Oklahoma, United States, 73102 | |
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| Oklahoma City, Oklahoma, United States, 73104-5020 | |
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| Oklahoma city, Oklahoma, United States, 73109 | |
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| Oklahoma City, Oklahoma, United States, 73112-4416 | |
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| Tulsa, Oklahoma, United States, 74133 | |
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| Tulsa, Oklahoma, United States, 74136 | |
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| Tulsa, Oklahoma, United States, 74104 | |
| United States, Oregon | |
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| Eugene, Oregon, United States, 97401 | |
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| Portland, Oregon, United States, 97216 | |
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| Portland, Oregon, United States, 97213-2996 | |
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| Portland, Oregon, United States, 97210 | |
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| Portland, Oregon, United States, 97225 | |
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| Springfield, Oregon, United States, 97477 | |
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| Tualatin, Oregon, United States, 97062 | |
| United States, Pennsylvania | |
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| Kingston, Pennsylvania, United States, 18704-5535 | |
| United States, South Carolina | |
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| Easley,, South Carolina, United States, 29640 | |
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| Greenville, South Carolina, United States, 29605 | |
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| Greenville, South Carolina, United States, 29615 | |
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| Spartanburg, South Carolina, United States, 29307 | |
| United States, Texas | |
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| Abilene, Texas, United States, 79606-5208 | |
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| Arlington, Texas, United States, 76012 | |
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| Arlington, Texas, United States, 76014 | |
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| Austin, Texas, United States, 78745 | |
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| Austin, Texas, United States, 78731 | |
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| Beaumont, Texas, United States, 77702-1449 | |
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| Bedford, Texas, United States, 76022` | |
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| Dallas, Texas, United States, 75246 | |
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| Dallas, Texas, United States, 75230-2510 | |
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| Dallas, Texas, United States, 75237 | |
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| Dallas, Texas, United States, 75231-4400 | |
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| Denton, Texas, United States, 76210 | |
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| El Paso, Texas, United States, 79902 | |
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| El Paso, Texas, United States, 79915 | |
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| Fort Worth, Texas, United States, 76104 | |
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| Fredericksburg, Texas, United States, 78624 | |
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| Garland, Texas, United States, 75042 | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77024 | |
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| Irving, Texas, United States, 75061-224 | |
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| Kerrville,, Texas, United States, 78028 | |
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| Lewisville, Texas, United States, 75067 | |
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| Longview, Texas, United States, 75601 | |
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| McAllen, Texas, United States, 78503 | |
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| Mesquite, Texas, United States, 75150 | |
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| Midland, Texas, United States, 79701 | |
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| New Braunfels, Texas, United States, 78130 | |
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| Odessa, Texas, United States, 79761 | |
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| Paris, Texas, United States, 75460-5004 | |
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| Plano, Texas, United States, 75075-7787 | |
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| Round Rock, Texas, United States, 78681 | |
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| San Antonio, Texas, United States, 78217 | |
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| San Antonio, Texas, United States, 78258-3912 | |
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| San Antonio, Texas, United States, 78229 | |
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| San Antonio,, Texas, United States, 78212 | |
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| Sherman, Texas, United States, TX 75090-0504 | |
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| Tyler, Texas, United States, 75702 | |
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| Waco, Texas, United States, 76712 | |
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| Webster, Texas, United States, 77598 | |
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| Weslaco, Texas, United States, 78596 | |
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| Wichita Falls, Texas, United States, 76310 | |
| United States, Virginia | |
| Pfizer Investigational Site | |
| Chesapeake, Virginia, United States, 23320 | |
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| Christianburg, Virginia, United States, 24073 | |
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| Christianburg,, Virginia, United States, 24073 | |
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| Fairfax, Virginia, United States, 22031 | |
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| Gainesville, Virginia, United States, 20155 | |
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| Hampton,, Virginia, United States, 23666 | |
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| Newport News, Virginia, United States, 23606 | |
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| Norfolk, Virginia, United States, 23502 | |
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| Pulaski, Virginia, United States, 24301 | |
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| Roanoke, Virginia, United States, 24101 | |
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| Salem, Virginia, United States, 24153 | |
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| Williamsburg,, Virginia, United States, 23188 | |
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| Woodbridge, Virginia, United States, 22191 | |
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| Wytheville, Virginia, United States, 24382 | |
| United States, Washington | |
| Pfizer Investigational Site | |
| Burien,, Washington, United States, 98166 | |
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| Edmonds, Washington, United States, 98026 | |
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| Seattle, Washington, United States, 98133-8414 | |
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| Seattle, Washington, United States, 98133 | |
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| Spokane, Washington, United States, 99216 | |
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| Spokane, Washington, United States, 99218 | |
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| Spokane, Washington, United States, 99202 | |
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| Vancouver, Washington, United States, 98686 | |
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| Vancouver, Washington, United States, 98684-6930 | |
| Pfizer Investigational Site | |
| Vancouver, Washington, United States, 98684 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided by Pfizer
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00036270 History of Changes |
| Other Study ID Numbers: | 971-ONC-0028-081, A5991026 |
| Study First Received: | May 8, 2002 |
| Results First Received: | October 30, 2009 |
| Last Updated: | March 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Tamoxifen Exemestane Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents Estrogen Antagonists Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013