Phase 3, open-label, randomized study comparing 3-monthly with monthly goserelin in pre-menopausal women with estrogen receptor-positive advanced breast cancer

Breast Cancer : the Journal of the Japanese Breast Cancer Society
Shinzaburo NoguchiEisei Shin

Abstract

Monthly goserelin 3.6 mg dosing suppresses estradiol (E2) production and has proven efficacy in pre-menopausal women with estrogen receptor (ER)-positive breast cancer. This non-inferiority study evaluated the efficacy and safety of 3-monthly goserelin 10.8 mg compared with monthly goserelin 3.6 mg. This was a Phase 3, open-label, multicenter trial. Pre-menopausal women with ER-positive advanced breast cancer were randomized to 3-monthly goserelin 10.8 mg or monthly goserelin 3.6 mg; all patients received concomitant tamoxifen (20 mg daily). The primary endpoint was progression-free survival (PFS) rate at 24 weeks; non-inferiority was to be confirmed if the entire 95 % confidence interval (CI) for the treatment difference was above -17.5 %. Secondary endpoints included objective response rate (ORR), serum E2 levels, safety, and tolerability. In total, 222 patients were randomized (goserelin 10.8 mg, n = 109; goserelin 3.6 mg, n = 113). PFS rate at week 24 was 61.5 % (goserelin 10.8 mg) and 60.2 % (goserelin 3.6 mg); treatment difference (95 % CI) was 1.3 % (-11.4, 13.9), confirming non-inferiority of goserelin 10.8 mg compared with goserelin 3.6 mg. ORR was 23.9 % (goserelin 10.8 mg) and 26.9 % (goserelin 3.6 mg); treatment dif...Continue Reading

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Citations

Mar 24, 2016·Asia-Pacific Journal of Clinical Oncology·Jane BeithAndrew Redfern
Mar 2, 2016·IEEE Transactions on Bio-medical Engineering·Hardik J PandyaJaydev P Desai
Jul 5, 2019·Breast Cancer Research and Treatment·Winnie YeoUNKNOWN Asian Breast Cancer Cooperative Group
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Oct 22, 2019·Frontiers in Oncology·Maira Huerta-ReyesArturo Aguilar-Rojas
Oct 25, 2020·Pharmaceutics·Nkiruka IbeanuSahar Awwad
Jun 10, 2018·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Aditya Bardia, Sara Hurvitz
Jul 23, 2018·Annals of Oncology : Official Journal of the European Society for Medical Oncology·F CardosoE P Winer

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NCT01073865

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