Status and phase
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About
RATIONALE: Estrogen can cause the growth of breast cancer cells. Letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known which regimen of letrozole is most effective in treating breast cancer in postmenopausal women who have received tamoxifen.
PURPOSE: This randomized phase III trial is comparing different regimens of letrozole to see how well they work in treating postmenopausal women with stage I, stage II, or stage III breast cancer previously treated with tamoxifen.
Full description
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are randomized to 1 or 2 treatment arms.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
INCLUSION CRITERIA
Signed informed consent prior to beginning protocol specific procedures.
Histologically proven breast cancer at the first diagnosis with tumor stage I-II-III. Patients with histologically documented (microscopic) infiltration of the skin (pT4) will also be eligible.
Axillary Nodal status allowed: Nx, pNo, pN1, pN2, pN3.
Postmenopausal status defined by one of the following:
Adjuvant TAM received for at least 2 years and not more than 3 years and 3 months. Patients treated with adjuvant chemotherapy, are required to have begun receiving TAM within 3 months after the completion of chemotherapy.
Definitive surgical treatment must be either mastectomy or breast conserving surgery, with axillary lymph node dissection or sentinel node biopsy for operable breast cancer.
ECOG/WHO performance Status 0-1. Patients must be accessible for treatment and follow-up.
Concomitant treatment with biphosphonates are allowed and should be recorded during the trial.
EXCLUSION CRITERIA
Primary purpose
Allocation
Interventional model
Masking
2,056 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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