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PENELOPE B

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ANZ 1402/GBG-78/BIG 1-13: PENELOPE B

BCT Study Chair:

Nicole McCarthy

A clinical trial for women who have received neoadjuvant (before surgery) chemotherapy for hormone receptor (HR) positive and HER2 normal (negative) breast cancer. Only women who have some cancer remaining in the surgically removed breast tissue are eligible, because this indicates a higher than average risk of the cancer coming back (relapse). They would usually be offered hormone (endocrine) treatment for at least five years. This trial is designed to find out whether adding one year of treatment with a new drug called palbociclib (PD-0332991) to standard hormone therapy will benefit women with this type of breast cancer.

international

-90

INTERNATIONAL

Total number of trial

participants internationally

australia & new zealand

90

AUSTRALIA & NEW ZEALAND

Total number of trial participants

in Australia and New Zealand

institutions

16

INSTITUTIONS

Total number of participating institutions

in Australia and New Zealand

PENELOPE B PUBLICATIONS

2026

Systemic Therapy Management Strategies for Early-Stage Breast Cancer in Australia.

Zdenkowski N, Dear R, Kumar S, Martin H, Sabanathan D, Luen SJ, Yeo B. Asia-Pacific Journal of Clinical Oncology. 2026; 1-13, https://doi.org/10.1111/ajco.70123, E-pub

2025

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

Final Survival Results from the Penelope-B trial investigating palbociclib vs placebo for patients with high-risk HR+/HER2- breast cancer and residual disease after neoadjuvant chemotherapy – PENELOPE-B.

Loibl S, Martin M, Bonnefoi H, Untch M, Kim S-B, Bear HD, Carcia-Saenz JA, Mele Olive M, McCarthy N, Gelmon K, Kelly CM, Im S-A, Reimer T, Martinez-Janez M, Zhang A, Toi M, Provencher L, Rugo HS, Gnant M, Makris A, Anton Torres A, Hirmas N, Holtshmidt J, Nekljudova V, Marme F. Annals of Oncology. 2025; 24 March 2025. DOI: 10.1016/j.annonc.2025.03.010, E-pub

2024

Relationship of adaptive subtyping and tumour heterogeneity of treatment response to neoadjuvant therapy in hormone receptor–positive HER2-negative early breast cancer: PENELOPE-B.

Denkert C, Rachakonda K, Filipits M, Weber K, Marme f, Untch M, Witkeiwicz AK, Im S-A, DeMichele A, Pehl A, van’t Veer L, Jank P, Schem C, Fasching PA, Reimer T, Knudsen ES, Liu Y, Rojo Todo FG, Turner NC, Loibl S. Journal of Clinical Oncology. 2024; 42(suppl. 16).:566; 10.1200/JCO.2024.42.16_suppl.566, Abstract

2023

Detection of circulating tumor DNA following neoadjuvant chemotherapy and surgery to anticipate early relapse in ER positive and HER2 negative breast cancer: Analysis from the PENELOPE-B trial.

Turner NC, Marme F, Kim S-B, Bonnefoi HR, Garcia-Saenz JA, Torres AA, Bear HD, Tsch H, Olive MM, McCarthy N, Jurado HC, Im s-A, Liu Y, Zhang Z, Weber KE, Felder B, Nekljudova V, Reimer T, Denkert C, Loible S. Journal of Clinical Oncology. 2023; 41(suppl 16):Oral Abstract 502, Abstract

2022

Development and Validation of a Composite Biomarker Predictive of Palbociclib + Endocrine Treatment Benefit in Early Breast Cancer: PENELOPE-B and PALLAS Trials.

Loibl S, Denkert C, Liu Y, Knudsen ES, DeMichele A, Zhang Z, Teply-Szymanski J, Filipits M, Fasching PA, Gnant M, Deng S, Balic M, Rojo M, Watson M, Deshpande C, Turner N, Metzger O, Theall KP, Witkiewicz A, Valota O, Symmans WF, Mayer EL. San Antonio Breast Cancer Symposium. 2022; Abstract #PD17-05, Abstract

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Institutions