Study Evaluating CCI-779 and Letrozole in Post-menopausal Women With Breast Cancer
Public ClinicalTrials.gov record NCT00083993. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study of Oral CCI-779 Administered in Combination With Letrozole vs. Letrozole Alone as First Line Hormonal Therapy in Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
In this clinical research study, postmenopausal subjects with metastatic breast cancer will be given either the combination of temsirolimus (CCI-779) and letrozole or a placebo and letrozole in first-line hormonal treatment. The primary endpoint of this study is to determine overall progression free survival. Individual subjects will participate in the active treatment phase of the study until disease progression or withdrawal of consent, provided that test article is being tolerated. All subjects will be asked to participate in the long-term follow-up phase of the study, which includes follow-up every 3 months until disease progression (for subjects who withdraw for reasons other than documented progressive disease) or until any new cancer treatment is received, and for survival. The estimated duration of study participation is 34 months.
Study identification
- NCT ID
- NCT00083993
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,236 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2004 (Type not available)
- Primary completion
- Oct 2006 (Actual)
- Completion
- Oct 2006 (Actual)
- Last update posted
- Nov 8, 2011
2004 – 2006
United States locations
- U.S. sites
- 112
- U.S. states
- 38
- U.S. cities
- 101
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Hoover | Alabama | 35216 | — |
| Not listed | Huntsville | Alabama | 35801 | — |
| Not listed | Tucson | Arizona | 85715 | — |
| Not listed | Jonesboro | Arkansas | 72401 | — |
| Not listed | Burbank | California | 91505 | — |
| Not listed | Campbell | California | 95008 | — |
| Not listed | Fountain Valley | California | 92708 | — |
| Not listed | Gilroy | California | 95020 | — |
| Not listed | Glendora | California | 91740 | — |
| Not listed | Modesto | California | 95355 | — |
| Not listed | Montebello | California | 90640 | — |
| Not listed | Pomona | California | 91767 | — |
| Not listed | Poway | California | 92064 | — |
| Not listed | Sacramento | California | 95816 | — |
| Not listed | San Diego | California | 92123 | — |
| Not listed | Santa Rosa | California | 95405 | — |
| Not listed | Soquel | California | 95073 | — |
| Not listed | Vista | California | 92083 | — |
| Not listed | Lakewood | Colorado | 80215 | — |
| Not listed | Norwalk | Connecticut | 06851 | — |
| Not listed | Washington D.C. | District of Columbia | 20010 | — |
| Not listed | Boca Raton | Florida | 33428 | — |
| Not listed | Fort Lauderdale | Florida | 33305 | — |
| Not listed | Hollywood | Florida | 33021 | — |
| Not listed | Jacksonville | Florida | 32209 | — |
| Not listed | Jacksonville | Florida | 32224 | — |
| Not listed | Lake Worth | Florida | 33461 | — |
| Not listed | Miami Shores | Florida | 33138 | — |
| Not listed | New Port Richey | Florida | 34652 | — |
| Not listed | Plantation | Florida | 33324 | — |
| Not listed | Sarasota | Florida | 34239 | — |
| Not listed | Zephyrhills | Florida | 33542 | — |
| Not listed | Atlanta | Georgia | 30309-1710 | — |
| Not listed | Columbus | Georgia | 31902 | — |
| Not listed | Roswell | Georgia | 30076 | — |
| Not listed | Thomasville | Georgia | 31792 | — |
| Not listed | Coeur d'Alene | Idaho | 83814 | — |
| Not listed | Centralia | Illinois | 62801 | — |
| Not listed | Skokie | Illinois | 60076 | — |
| Not listed | Skokie | Illinois | 60077 | — |
| Not listed | Springfield | Illinois | 62702 | — |
| Not listed | Urbana | Illinois | 61801 | — |
| Not listed | Munster | Indiana | 46321 | — |
| Not listed | South Bend | Indiana | 46601 | — |
| Not listed | Lexington | Kentucky | 40504 | — |
| Not listed | Baltimore | Maryland | 21201 | — |
| Not listed | Baltimore | Maryland | 21231 | — |
| Not listed | Baltimore | Maryland | 21237 | — |
| Not listed | Bethesda | Maryland | 20817 | — |
| Not listed | Frederick | Maryland | 21701 | — |
| Not listed | Towson | Maryland | 21204 | — |
| Not listed | Boston | Massachusetts | 02118 | — |
| Not listed | Boston | Massachusetts | 02135 | — |
| Not listed | Ann Arbor | Michigan | 48109 | — |
| Not listed | Detroit | Michigan | 48202 | — |
| Not listed | Flint | Michigan | 48503 | — |
| Not listed | Grand Rapids | Michigan | 49503 | — |
| Not listed | Grand Rapids | Michigan | 49546 | — |
| Not listed | Minneapolis | Minnesota | 55455 | — |
| Not listed | Hattiesburg | Mississippi | 39401 | — |
| Not listed | Rolla | Missouri | 65401 | — |
| Not listed | Great Falls | Montana | 59406 | — |
| Not listed | Omaha | Nebraska | 68198 | — |
| Not listed | Carson City | Nevada | 89703 | — |
| Not listed | Lebanon | New Hampshire | 03756 | — |
| Not listed | Belleville | New Jersey | 07109 | — |
| Not listed | Somerset | New Jersey | 08873 | — |
| Not listed | Albuquerque | New Mexico | 87109 | — |
| Not listed | Binghamton | New York | 13905 | — |
| Not listed | East Syracuse | New York | 13057 | — |
| Not listed | New York | New York | 10032 | — |
| Not listed | Nyack | New York | 10960 | — |
| Not listed | Staten Island | New York | 10305 | — |
| Not listed | Charlotte | North Carolina | 28203 | — |
| Not listed | Gastonia | North Carolina | 28054 | — |
| Not listed | Wilmington | North Carolina | 28401 | — |
| Not listed | Winston-Salem | North Carolina | 27103 | — |
| Not listed | Bismarck | North Dakota | 58504 | — |
| Not listed | Canton | Ohio | 44710 | — |
| Not listed | Canton | Ohio | 44718 | — |
| Not listed | Cincinnati | Ohio | 45219 | — |
| Not listed | Cincinnati | Ohio | 45238 | — |
| Not listed | Cleveland | Ohio | 44106-5055 | — |
| Not listed | Cleveland | Ohio | 44195 | — |
| Not listed | Columbus | Ohio | 43215 | — |
| Not listed | Columbus | Ohio | 43235 | — |
| Not listed | Mayfield Heights | Ohio | 44124 | — |
| Not listed | Corvallis | Oregon | 97330 | — |
| Not listed | Portland | Oregon | 97213 | — |
| Not listed | Harrisburg | Pennsylvania | 17110 | — |
| Not listed | Hershey | Pennsylvania | 17033 | — |
| Not listed | Langhorne | Pennsylvania | 19047 | — |
| Not listed | Philadelphia | Pennsylvania | 19106 | — |
| Not listed | Pittsburgh | Pennsylvania | 15213 | — |
| Not listed | Charleston | South Carolina | 29425 | — |
| Not listed | Columbia | South Carolina | 29169 | — |
| Not listed | Chattanooga | Tennessee | 37404 | — |
| Not listed | Nashville | Tennessee | 37203 | — |
| Not listed | Nashville | Tennessee | 37205 | — |
| Not listed | Arlington | Texas | 76012 | — |
| Not listed | Corpus Christi | Texas | 78412 | — |
| Not listed | Dallas | Texas | 75230 | — |
| Not listed | Fort Worth | Texas | 76104 | — |
| Not listed | Irving | Texas | 75038 | — |
| Not listed | Tyler | Texas | 75701 | — |
| Not listed | Logan | Utah | 84341 | — |
| Not listed | Ogden | Utah | 84403 | — |
| Not listed | Arlington | Virginia | 22205-3637 | — |
| Not listed | Richmond | Virginia | 23294 | — |
| Not listed | Woodbridge | Virginia | 22191 | — |
| Not listed | Seattle | Washington | 98101 | — |
| Not listed | Morgantown | West Virginia | 26505 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 17 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00083993, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 8, 2011 · Synced Nov 9, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00083993 live on ClinicalTrials.gov.