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PALLAS

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ANZ 1603/ABCSG 42: PALLAS

BCT Study Chair:

Nicholas Zdenkowski

An international clinical trial, open to both women and men diagnosed with Hormone Receptor (HR) positive, Human Epidermal Growth Factor Receptor 2 (HER2) negative, early stage breast cancer. PALLAS aims to find out if patients with early stage breast cancer could benefit from receiving 2 years of Palbociclib along with standard hormone treatment, compared with standard hormone treatment alone.

international

5361

INTERNATIONAL

Total number of trial

participants internationally

australia & new zealand

434

AUSTRALIA & NEW ZEALAND

Total number of trial participants

in Australia and New Zealand

institutions

21

INSTITUTIONS

Total number of participating institutions

in Australia and New Zealand

PALLAS PUBLICATIONS

2025

Quality-of-life and symptom severity in the PALLAS randomized trial of palbociclib with adjuvant endocrine therapy in early breast cancer (AFT-05, ABCSG-42, BIG-14-03, PrE0109).

Naughton MJ, Zahrieh DM, Gnant M, Zdenkowski N, Lemieux J, Mao JJ, Bjelic-Radisic V, Shinn E, Balic M, Thomssen C, Meisel JL, Ruiz GM, Loibl S, Isaacs C, Cameron D, Henao-Carrasco FM, Goetz MP, Singer SF, Werutsky G, Rugo HS, Vetter M, Tseng L-M, Miller K, Fitzal F, Gil Gil JM, Park H, Linderholm B, Bajetta E, Dayao Z, Prat A, Ehrhardt K, Metzger O, Arahmani A, Law EH, Partridge AH, Carey LA, Zoroufy A, Dueck AC, O’Brien P, Hlauschek D, DeMichele A & Mayer EL. ESMO Open. 2025; 10(6):105120, DOI: 10.1016/j.esmoop.2025.105120, E-pub

Drug-drug interactions between palbociclib and proton pump inhibitors in early breast cancer: an exploratory analysis of PALLAS (ABCSG-42/AFT-05/BIG-14-13/PrE0109).

Agostinetto E, Pfeiler G, Hlauschek D, Mayer EL, Lambertini M, de Azambuja E, Bellet-Ezquerra M, Meisel JL, Rubovszky G, Zdenkowski N, Novik Y, Ruiz-Borrego M, Gelmon KA, Mamounas EP, Iwata H, Lu DR, Soelkner L, Fesl C, Gnant M, DeMichele A. ESMO Open. 2025; 10(1):104096, DOI: 10.1016/j.esmoop.2024.104096., E-pub

Relationship between physician-graded symptomatic adverse events and patient-reported quality of life (QOL): An analysis of the phase III PALLAS trial.

Bjelic-Radisic V, Solkner L, Demichele A, Naughton M, Lemieux J, Zdenkowski N, Ruiz Borrego M, Mao J, Shinn E, Singer CF, Meisel J, Chan A, Iwata H, Mamounas T, Loible S, Gauthier E, Dueck A, Hlauschek D, Mayer E, Gnant MI, on behalf of the PALLAS groups and investigators (ABCST, AFT, BIG, PReCOG, GBG, NASBP). ESMO Open. 2025; 10(4 suppl):DOI: https://doi.org/10.1016/j.esmoop.2025.104879, Abstract 307P., Abstract

CDK4/6 inhibitors in combination with endocrine therapy in patients with early-stage breast cancer (HR+/HER2-): A metanalysis based on updated results of randomized phase III trials.

Saloustros E, Alexiou S, Mavrovounis G, Christodooulopoulos G, Sotiri SP. ESMO Open. 2025; 10(suppl 4):DOI: https://doi.org/10.1016/j.esmoop.2025.104814, Abstract 260P, Abstract

Treatment-related neutropenia as a predictor of response to adjuvant palbociclib in the PALLAS trial (ABCSG-42/AFT-05/BIG-14-13/PrE0109).

Fanucci K, Dueck AC, Mayer EL, Martin M, Haddad TC, Zdenkowski N, Steger GG, Novic Y, Suga JM, Lemieux J, Traina TA, Loibl S, Gellet M, Wolff AC, Machacek-Link J, Gauthier ER, Scovil S, Hlauschek D, Gnant M, DeMichele A. Journal of Clinical Oncology. 2025; 43(16 suppl).:ASCO Abs526. DOI: 10.1200/JCO.2025.43.16_suppl.526, Abstract

2024

Analysis of the sensitivity to endocrine therapy (SET) assay in the PALLAS adjuvant trial of palbociclib in HR+/HER2- breast cancer (ABCSG-42/AFT-05/BIG-14-13).

Metzger O, Ballman KV, Gnant M, Watson M, Chen E, Tran K, O’Brien P, Hlauschek D, Martin M, Balko JM, sowecki Z, Hahn OM, Denkert C, Curtis C, Liu Y, Dueck AC, Fesl C, Mayer EL, DeMichele A, Symmans WF. Journal of Clinical Oncology 2024; 42(suppl 16).:ASCO 2024, 538; 10.1200/JCO.2024.42.16_suppl.538, Abstract

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