Letrozole in Treating Postmenopausal Women Who Have Received Hormone Therapy for Hormone Receptor-Positive Breast Cancer

Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether letrozole is more effective than a placebo in treating patients with hormone receptor-positive breast cancer. PURPOSE: This randomized phase III trial is studying letrozole to see how well it works compared with a placebo in treating postmenopausal women who have received hormone therapy for hormone receptor-positive breast cancer.

Timeline

Start

2006-08

Primary completion

2016-08-25

Completion

2025-04

Publications

• Background Mamounas EP, Lembersky B, Jeong JH, Cronin W, Harkins B, Geyer C, Wickerham DL, Paik S, Costantino J, Wolmark N. NSABP B-42: a clinical trial to determine the efficacy of five years of letrozole compared with placebo in patients completing five years of hormonal therapy consisting of an aromatase inhibitor (AI) or tamoxifen followed by an AI in prolonging disease-free survival in postmenopausal women with hormone receptor-positive breast cancer. Clin Breast Cancer. 2006 Dec;7(5):416-21. doi: 10.3816/CBC.2006.n.061. No abstract available.
• Rastogi P, Bandos H, Lucas PC, van 't Veer LJ, Wei JJ, Geyer CE Jr, Fehrenbacher L, Chia SKL, Brufsky AM, Walshe JM, Soori GS, Dakhil SR, Paik S, Swain SM, Menicucci AR, Audeh MW, Wolmark N, Mamounas EP. Utility of the 70-Gene MammaPrint Assay for Prediction of Benefit From Extended Letrozole Therapy in the NRG Oncology/NSABP B-42 Trial. J Clin Oncol. 2024 Oct 20;42(30):3561-3569. doi: 10.1200/JCO.23.01995. Epub 2024 Jul 24.
• Mamounas EP, Bandos H, Lembersky BC, Jeong JH, Geyer CE Jr, Rastogi P, Fehrenbacher L, Graham ML, Chia SK, Brufsky AM, Walshe JM, Soori GS, Dakhil SR, Seay TE, Wade JL 3rd, McCarron EC, Paik S, Swain SM, Wickerham DL, Wolmark N. Use of letrozole after aromatase inhibitor-based therapy in postmenopausal breast cancer (NRG Oncology/NSABP B-42): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Jan;20(1):88-99. doi: 10.1016/S1470-2045(18)30621-1. Epub 2018 Nov 30.

Drugs

Indications