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Brief Title † | Letrozole After Tamoxifen in Treating Women With Breast Cancer | ||||||||||||||||||||||||||||
Official Title † | A Phase III Randomized Double Blind Study of Vorozole Versus Placebo in Women With Primary Breast Cancer Completing Five or More Years of Adjuvant Tamoxifen | ||||||||||||||||||||||||||||
Brief Summary | RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by reducing the production of estrogen. PURPOSE: This randomized phase III trial is studying letrozole to see how well it works in treating women with breast cancer who have received tamoxifen for at least 5 years. |
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Detailed Description | OBJECTIVES: Primary
Secondary
Primary
Secondary
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to receptor status (positive vs unknown), lymph node status (negative vs positive vs unknown), prior adjuvant chemotherapy (yes vs no), interval between last dose of aromatase inhibitor therapy and randomization (< 6 months vs 6 months-2 years), and duration of prior tamoxifen use (0 years vs < 2 years vs 2-4.5 years vs > 4.5 years). Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline, at 6 months, and then annually for 4.5 years.
Patients who complete ≥ 4.5 years of letrozole (arm I) and who did not experience recurrent disease or new primary breast cancer, including ductal carcinoma in situ, may participate in the double-blind, placebo-controlled, re-randomization portion of the study. Patients are stratified according to lymph node status at enrollment (negative vs positive vs unknown), prior adjuvant chemotherapy (yes vs no), and interval between last dose of letrozole and re-randomization (<6 months vs 6 months to 2 years). Common genetic single nucleotide polymorphisms for genes encoding proteins involved in pharmacokinetic and/or pharmacodynamic pathways for letrozole are analyzed in order to determine if these single nucleotide polymorphisms contribute to individual variation in toxicity and efficacy of letrozole therapy. Quality of life is assessed as during the first randomization. Patients are followed annually. PROJECTED ACCRUAL: A total of 4,700 patients will be accrued for this study. |
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Study Phase | Phase III | ||||||||||||||||||||||||||||
Study Type † | Interventional | ||||||||||||||||||||||||||||
Study Design † | Treatment, Randomized, Double-Blind, Placebo Control | ||||||||||||||||||||||||||||
Primary Outcome Measure † | Disease-free survival [ Designated as safety issue: No ] | ||||||||||||||||||||||||||||
Secondary Outcome Measure † | |||||||||||||||||||||||||||||
Condition † | Breast Cancer | ||||||||||||||||||||||||||||
Intervention † | Drug: letrozole | ||||||||||||||||||||||||||||
MEDLINE PMIDs | 18332475, 18332043, 18332474, 17452676, 16541302, 16822845, 16145047, 16157934, 14551341, 16046117, 15284712, 17354227, 16870082, 16526826, 16912269, 16595026 | ||||||||||||||||||||||||||||
Links | Clinical trial summary from the National Cancer Institute's PDQ® database  | ||||||||||||||||||||||||||||
Recruitment Information Fields | |||||||||||||||||||||||||||||
Recruitment Status † | Recruiting | ||||||||||||||||||||||||||||
Enrollment † | 4700 | ||||||||||||||||||||||||||||
Start Date † | August 1998 | ||||||||||||||||||||||||||||
Completion Date | |||||||||||||||||||||||||||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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Gender | Female | ||||||||||||||||||||||||||||
Ages | |||||||||||||||||||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||||||||||||||||||
Contacts †† | |||||||||||||||||||||||||||||
Location Countries † | United States, Canada | ||||||||||||||||||||||||||||
Administrative Information Fields | |||||||||||||||||||||||||||||
NCT ID † | NCT00003140 | ||||||||||||||||||||||||||||
Organization ID | CDR0000065921 | ||||||||||||||||||||||||||||
Secondary IDs †† | CAN-NCIC-MA17, CALGB-49805, E-JMA17, EORTC-10983, IBCSG-BIG97-01, NCCTG-JMA17, SWOG-JMA17, JRF-Vor-Int-10, NCCTG-CAN-MA17, SWOG-CAN-MA17 | ||||||||||||||||||||||||||||
Study Sponsor † | National Cancer Institute of Canada | ||||||||||||||||||||||||||||
Collaborators †† | National Cancer Institute (NCI) North Central Cancer Treatment Group International Breast Cancer Study Group Eastern Cooperative Oncology Group Southwest Oncology Group Cancer and Leukemia Group B European Organization for Research and Treatment of Cancer |
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Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||||||||||||||||||||||||||
Verification Date | January 2009 | ||||||||||||||||||||||||||||
First Received Date † | November 1, 1999 | ||||||||||||||||||||||||||||
Last Updated Date | January 15, 2009 |