Letrozole in Treating Breast Cancer in Postmenopausal Women With Stage I, II, or III Breast Cancer Previously Treated With Tamoxifen (GIM4)

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:
• •* Age \> 55 years with cessation of menses
• •* Age \< 55 years but not spontaneous menses for at least 1 year
• •* Age \< 55 years and spontaneous menses within the past 1 year, but currently amenorrheic (e.g. spontaneous, or secondary to hysterectomy), AND with postmenopausal gonadotrophin levels (luteinizing hormone and follicle stimulating hormone levels \>40 IU/L) or postmenopausal estradiol levels (\<5 ng/dL) or according to the definition of "postmenopausal range" for the laboratory involved.
• •* Bilateral oophorectomy
• •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.