LUMC-Heelkunde; PI vd Velde
C. J. H. van de Velde, J.W.R. Nortier
E. Meershoek-Klein Kranenbarg
Leiden University Medical Center Datacenter Surgery K6-R P.O. Box 9600, 2300 RC Leiden Phone +31 71 526 3500 Fax +31 71 526 6744 E-mail datacenter@lumc.nl
Randomization: Arm A: 2,5 year duration of letrozole treatment Arm B: 5 year duration of letrozole treatment
Primary To investigate whether 5 years of extended adjuvant treatment with letrozole results in an improved DFS compared to 2.5 years treatment in patients with early breast cancer previously treated with endocrine agents for 5 years Secondary: To compare the efficacy of 2.5 vs. 5 years of extended adjuvant letrozole with respect to Overall survival Distant disease free survival Contralateral breast cancer Safety.
Primary endpoint:
Secondary endpoints:
Postmenopausal ER and/or PgR positive Completed 5 year (± 3 months) adjuvant endocrine therapy with either tamoxifen for 5 years, aromatase inhibitors for 5 years or a sequence of both (provided that tamoxifen was given upfront for 2-3 years) Adjuvant endocrine treatment completed for no longer than 2 years (with a tolerance window of 3 months)
