Study Evaluating Temsirolimus (CCI-779) In Breast Neoplasms
NCT00062751
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Postmenopausal women with histologically confirmed, measurable locally advanced disease or metastatic breast.
- Must be appropriate to receive endocrine therapy as treatment for advanced disease (chemotherapy; prior adjuvant therapy with antiestrogens other than aromatase inhibitors; prior adjuvant or first-line metastatic therapy with tamoxifen or trastuzumab, are permitted).
- Women may either present with de novo advanced or metastatic cancer, or have had tumor progression while receiving adjuvant tamoxifen or at any time after completing adjuvant tamoxifen, or have had tumor progression while receiving first-line metastatic therapy with tamoxifen.
- Patients having known central nervous system (CNS) metastases.
- Prior therapy with Temsirolimus (CCI-779) or aromatase inhibitors.
- Tamoxifen, or other hormonal therapy, in the metastatic or adjuvant setting within 1
week prior to day 1 of treatment on study.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Manresa, Barcelona
- Terrassa, Barcelona
- San Sebastián, Donostia
- Las Palmas de Gran Canaria, Gran Canaria
- Alcorcón, Madrid
- Fuenlabrada, Madrid
- Leganés, Madrid
- San Sebastián de los Reyes, Madrid
- Palma de Mallorca, Mallorca
- Pamplona, Navarra
- Santa Cruz de Tenerife, Tenerife
- Bilbao, Vizcaya
- A Coruña,
- Albacete,
- Alicante,
- Barcelona,
- Barcelona,
- Barcelona,
- Barcelona,
- Barcelona,
- Barcelona,
- Cáceres,
- Córdoba,
- León,
- Lugo,
- Madrid,
- Madrid,
- Murcia,
- Málaga,
- Salamanca,
- Sevilla,
- Toledo,
- Valencia,
- Valencia,
- Valencia,
- Valencia,
- Zaragoza,
- Zaragoza,
- Elche, Alicante
- Sagunto, Valencia
- Ávila,
- St. Louis, Missouri
- Nagoya, Aichi
- Kashiwa, Chiba
- Matsuyama, Ehime
- Sapporo, Hokkaido
- Akashi, Hyogo
- Yokohama, Kanagawa
- Ōsaka-sayama, Osaka
- Minato-Ku, Tokyo
- Chiba,
- Fukuoka,
- Osaka,
- Seoul,
- Seoul,
- Singapore,
- Taipei,
- Taipei,
- Singapore,
- Gyeonggi-do,
- Soeul,
- Tokyo,
- Gyeonggi-do,
- Taipei,
- Gyeonggi-do,
- Birmingham, Alabama
- Scottsdale, Arizona
- Rochester, Minnesota
- Saint Louis, Missouri
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Study Evaluating Temsirolimus (CCI-779) In Breast Neoplasms | |||
Official Title ICMJE | A Phase 2 Randomized Open-Label Study Of Letrozole In Combination With Two Dose Levels And Schedules Of Oral Temsirolimus (CCI-779), Or Letrozole Alone, In Postmenopausal Women With Locally Advanced Or Metastatic Breast Cancer | |||
Brief Summary | To evaluate the preliminary activity and pharmacokinetics of 2 separate doses and schedules of orally administered Temsirolimus (CCI-779) given in combination with daily letrozole, compared to letrozole alone, in the treatment of locally advanced or metastatic breast cancer in postmenopausal women. All patients must be appropriate to receive endocrine therapy as treatment for advanced disease. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Breast Neoplasms | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Not Provided | |||
* 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 | 108 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | October 2009 | |||
Actual Primary Completion Date | April 2005 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion 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 | Not Provided | |||
Removed Location Countries | United States | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00062751 | |||
Other Study ID Numbers ICMJE | 3066A1-204 B1771005 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
| |||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | April 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |