Exemestane Compared With Tamoxifen in Treating Postmenopausal Women With Breast Cancer
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ClinicalTrials.gov Identifier: NCT00032136 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : August 2, 2013
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Tracking Information | ||||
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First Submitted Date ICMJE | March 8, 2002 | |||
First Posted Date ICMJE | January 27, 2003 | |||
Last Update Posted Date | August 2, 2013 | |||
Study Start Date ICMJE | December 2001 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE |
Relapse-free survival | |||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Exemestane Compared With Tamoxifen in Treating Postmenopausal Women With Breast Cancer | |||
Official Title ICMJE | An Open Label, Randomized Multicenter Comparative Trial Of 5 Years Adjuvant Exemestane Treatment Versus 5 Years Adjuvant Tamoxifen Treatment In Postmenopausal Women With Early Breast Cancer | |||
Brief Summary | RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen. It is not yet known if exemestane is more effective than tamoxifen in preventing the recurrence of breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of exemestane with that of tamoxifen in treating postmenopausal women who have undergone surgery to remove early-stage breast cancer. |
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Detailed Description | OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to estrogen receptor (ER)/progesterone receptor (PgR) status (ER positive vs ER negative/PgR positive vs ER positive/PgR unknown), prior chemotherapy (none vs taxane-based vs anthracycline-based vs other), and nodal status (negative vs 1-3 nodes positive vs 4 or more nodes positive). Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline and at months 3 and 12 during study. Patients are followed at least annually. PROJECTED ACCRUAL: Approximately 4,400 patients (2,200 per treatment arm) will be accrued for this study. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Breast Cancer | |||
Intervention ICMJE |
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Study Arms ICMJE | Not Provided | |||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE |
4400 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | April 2009 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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Sex/Gender ICMJE |
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Ages ICMJE | Child, 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 Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00032136 | |||
Other Study ID Numbers ICMJE | CRC-TU-TEAM CDR0000069260 ( Registry Identifier: PDQ (Physician Data Query) ) EU-20149 ISRCTN75225940 |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Not Provided | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Cancer Research Campaign Clinical Trials Centre | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | National Cancer Institute (NCI) | |||
Verification Date | March 2007 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |