Indications and Usage for Letrozole Letrozole tablets are indicated for the adjuvant treatment of postmenopausal women with hormone receptor
positive early breast cancer.
Raw Letrozole powder Extended Adjuvant Treatment of Early Breast Cancer Letrozole tablets
are indicated for the extended adjuvant treatment of early breast cancer
in postmenopausal women, who have received 5 years of adjuvant
tamoxifen therapy. The effectiveness of Letrozole tablets in extended
adjuvant treatment of early breast cancer is based on an analysis of
disease-free survival in patients treated with Letrozole tablets for a
median of 60 months [see Clinical Studies (14.2, 14.3)]. First and
Second-Line Treatment of Advanced Breast Cancer Letrozole tablets are
indicated for first-line treatment of postmenopausal women with hormone
receptor positive or unknown, locally advanced or metastatic breast
cancer. Letrozole tablets are also indicated for the treatment of
advanced breast cancer in postmenopausal women with disease progression
following antiestrogen therapy [see Clinical Studies (14.4, 14.5)]. In
the adjuvant setting, the optimal duration of treatment with Letrozole
is unknown. In both the adjuvant study and the post approval adjuvant
study, median treatment duration was 5 years. Treatment should be
discontinued at relapse [see Clinical Studies (14.1)]. In the extended
adjuvant setting, the optimal treatment duration with Letrozole tablets
are not known. The planned duration of treatment in the study was 5
years. In the final updated analysis, conducted at a median follow-up of
62 months, the median treatment duration for Letrozole tablets was 60
months. Seventy-one (71%) percent of patients were treated for at least 3
years and 58% of patients completed at least 4.5 years of extended
adjuvant treatment. The treatment should be discontinued at tumor
relapse [see Clinical Studies (14.2)].
