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

2024

Patient-Reported Outcomes in OlympiA: A Phase III, Randomized, Placebo-Controlled Trial of Adjuvant Olaparib in gBRCA1/2 Mutations and High-Risk Human Epidermal Growth Factor Receptor 2–Negative Early Breast Cancer.

Ganz PA, Bandos H, Spanic T, Friedman S, Muller V, Kuemmel S, Delaloge S, Brain E, Toi M, Yamauchi H, de Duenas E-M, Armstrong A, Im S-A, Song C, Zheng H, Sarsiek T, Sharma P, Geng C, Fu P, Rhiem K, Frachiger-Heuer H, Wimberger P, d’Kind de Roodenbeke D, Liao N, Goodwin A, Chakiba-Brugere C, Friedlander M, Lee KS, Giacchetti S, Takano T, Henao-Carrasco F, Virani S, Valdes-Albini F, Domchek SM, Bane C, McCarron EC, Mita M, Rossi G, Rastogi P, Fielding A, Gelber RD, et al. Journal of Clinical Oncology. 2024; 42(11):1288-1300, DOI https://doi.org/10.1200/JCO.23.01214, E-pub

2023

Adjuvant olaparib in the subset of patients from Japan with BRCA1- or BCRA2-mutated high-risk early breast cancer from the phase 3 OlympiA trial.

Yamauchi H, Toi M, Takayama S, Nakamura S, Takano T, Cui K, Campbell C, De Vos L, Geyer Jr C, Tutt A. Breast Cancer. 2023; 30596-605, https://doi.org/10.1007/s12282-023-01451-8, E-pub

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

OlympiA