Alternative Dosing of Exemestane Before Surgery in Treating Postmenopausal Patients With Stage 0-II Estrogen Positive Breast Cancer

Summary

This phase IIb trial studies how well alternative dosing of exemestane before surgery works in treating in postmenopausal patients with stage 0-II estrogen positive breast cancer. Chemoprevention is the use of drugs to keep breast cancer from forming or coming back. The use of exemestane may treat early stage (stage 0-II) breast cancer. Comparing the exemestane standard dose regimen versus two alternative, less frequent dose regimens may decrease undesirable symptoms and have similar efficacy in reducing serum estradiol.

Timeline

Start

2016-12-06

Primary completion

2019-10-03

Completion

2023-02-02

Publications

• Serrano D, Johansson H, Bertelsen BE, Gandini S, Mellgren G, Thomas P, Crew KD, Kumar NB, Macis D, Aristarco V, Guerrieri-Gonzaga A, Lazzeroni M, D'Amico M, Buttiron-Webber T, Briata IM, Spinaci S, Galimberti V, Vornik LA, Vilar E, Brown PH, Heckman-Stoddard BM, Szabo E, Bonanni B, DeCensi A. Drug and biomarker tissue levels in a randomized presurgical trial on exemestane alternative schedules. J Natl Cancer Inst. 2024 Dec 1;116(12):1979-1982. doi: 10.1093/jnci/djae183.
• Serrano D, Gandini S, Thomas P, Crew KD, Kumar NB, Vornik LA, Lee JJ, Veronesi P, Viale G, Guerrieri-Gonzaga A, Lazzeroni M, Johansson H, D'Amico M, Guasone F, Spinaci S, Bertelsen BE, Mellgren G, Bedrosian I, Weber D, Castile T, Dimond E, Heckman-Stoddard BM, Szabo E, Brown PH, DeCensi A, Bonanni B. Efficacy of Alternative Dose Regimens of Exemestane in Postmenopausal Women With Stage 0 to II Estrogen Receptor-Positive Breast Cancer: A Randomized Clinical Trial. JAMA Oncol. 2023 May 1;9(5):664-672. doi: 10.1001/jamaoncol.2023.0089.

Drugs

Indications