OlympiA

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ANZ 1404/BIG 6-13/AstraZeneca D081CC00006: OlympiA

BCT Study Chair:

Kelly-Anne Phillips

A randomized, double blind, parallel group, placebo-controlled multi-center phase III study to assess the efficacy and safety of olaparib versus placebo as adjuvant treatment in patients with germline BRCA 1/2 mutations and high risk HER2-negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy.

1776

INTERNATIONAL

Total number of trial

participants internationally

60

AUSTRALIA & NEW ZEALAND

Total number of trial participants

in Australia and New Zealand

15

INSTITUTIONS

Total number of participating institutions

in Australia and New Zealand

OLYMPIA PUBLICATIONS

2022

Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high-risk, early breast cancer.

Geyer CE, Garber JE, Gelber RD, Yothers et al. and the OlympiA Clinical Trial Steering Committee and Investigators. Annals of Oncology. 2022; 33(12):1250 – 1268, Journal

2021

Quality of life results from OlympiA: A phase III, multicenter, randomized, placebo-controlled trial of adjuvant olaparib after (neo)-adjuvant chemotherapy in patients with germline BRCA1/2 mutations and high-risk HER-2 negative early breast cancer.

Ganz P, Bandos H, Spanic T, Friedman S, Muller V, Kummel S, Delaloge S, Brain E, Toi M, Yamauchi H, de Duenas E-M, Armstron A, Im S-A, Song C, Zheng H, Sarosiek T, Sharma P, Rossi G, Rastogi P, Fielding A, Gelber RD, Campbell C, Garber JE, Geyer Jr CE, Tutt ANJ, on behalf of the OlympiA Trial Steering Committee and Investigators. SABCS 2021; GS4-09, Abstract

OlympiA: A phase III, multicenter, randomized, placebo-controlled trial of adjuvant olaparib after (neo)adjuvant chemotherapy in patients with germline BRCA 1/2 mutations and high-risk HER2-negative early breast cancer.

Tutt A, Garber JE, Kaufman B, Viale G, Fumagalli D, Rastogi P, Gelber RD, de Azambuja E, Fielding A, Balmana Gelpi J, Gelmon KA, Baker N, Arahmani A, Senkus-Konefka E, Mc Fadden E, Karantza V, Lakhani SR, Yothers G, Campbell C, Geyer CE. Journal of Clinical Oncology. 2021; 39(Suppl. 15):#LBA1, Presentation

Customising Local and Systemic Therapies for women with Early Breast Cancer: The St. Gallen International Consensus Guidelines for treatment of early breast cancer 2021.

Burstein HJ, Curigliano G, Thurlimann B, Weber WP, Poortmans P, Regan M, Senn HJ, Winer EP, Gnant M, Panelists of the St Gallen Consensus Conference. Annals of Oncology. 2021; (in press)DOI:https://doi.org/10.1016/j.annonc.2021.06.023., Journal

Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer.

Tutt ANJ, Garber JE, Kaufman B, Viale G, Fumagalli D, Rastogi P, Gelber RD, de Azambuja E, Fielding A, Balmana J, Domchek SM, Gelmon KA, Hollingsworth SJ, Dorde LA, Linderholm B, Bandos H, Senkus E, Suga JM, Shao Z, Pippas AW, Nowecki Z, Huzarski T, Ganz PA, Lucas BC, Baker N, Loibl S, McConnell R, Piccart M, Schmutzler R, Steger GG, Costantino JP, Arahmani A, Wolmarck N, McFadden E, Karantza V, Lakhani SR, Yothers G, Campbell C, Geyer Jr CE, for the OlympiA Steering Committee and Investigators New England Journal of Medicine. 2021; 384(22):epub 03 June 2021, https://www.nejm.org/doi/full/10.1056/NEJMoa210521, E-pub

2017

OlympiA: A randomized phase III trial of olaparib as adjuvant therapy in patients with high-risk HER2-negative breast cancer (BC) and a germline BRCA1/2 mutation (gBRCAm).

Tutt A, Kaufman B, Garber J, Gelber R, McFadden E, Goessl C, Viale G, Geyer C, Zardavas D, Arahmani A, Fumagalli D, De Azambuja E, Pnde N, Herbolsheimer P, Wu W, Contantino J, Rastogi P. Annals of Oncology 2017; 28(supp 5):[216TiP], Poster

OlympiA