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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

1160

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

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

Immunohistochemical markers and determinants of clinical response in the Penelope-B trial.

Knudsen ES, Rachakonda S, Marme F, Marin M, Untch M, Bonnefoi HR, Schmitt WD, Sung-Bai K, Bear HD, Witkiewicz A, Seock-Ah I, DeMichele A, Van’t Veer L, McCarthy N, Sinn BV, Gelmon K, Garcia-Saenz JA, Kelly CM, Reimer T, Turner N, Rojo F, Filipits M, Fasching PA, Schem C, Martin L-A, Liu Y, Toi M, Rugo H, Gnant M, Makris A, Furlanetto J, Weber K, Denkert C, Loibl S. San Antonio Breast Cancer Symposium. 2022; Abstract #PD17-06, Abstract

Outcome analysis of HER2-zero or HER2-low hormone receptor-positive (HR+) breast cancer patients – characterization of the molecular phenotype in combination with molecular subtyping.

Denkert C, Martin M, Untch M, Bonnefoi HR, Knudsen ES, Im S-A, DeMichele A, Witkiewicz A, Van’t Veer L, Kim S-B, Bear HD, McCarthy N, Gelmon K, Marme F, Carcia-Saenz JA, Turner N, Rojo F, Filipits M, Martin L-A, Fasching PA, Schem C, Kelly CM, Reimer T, Toi M, Rugo H, Gnant M, Makris A, Liu Y, Weber K, Rachakonda S, Loibl S. San Antonio Breast Cancer Symposium. 2022; Abstract# HER2-06, Abstract

Ovarian function in young patients (pts) treated with postneoadjuvant palbociclib (PAL) and endocrine therapy (ET) for hormone receptor (HR)-positive, HER2-negative early breast cancer (BC): Explorative analysis in Penelope-B.

Furlanetto J, Marm F, Thode C, Nekljudova V, Liu Y, Martin Jimenez M, Reimer T, Knudsen E, Denkert C, Bassy M, Martin L-A, Karn T, Sinn B.V, Filipitis M, Van Mackelenbergh M, Fasching P.A, Muller. V, Stickeler E, Schem C, Loibl S. Annals of Oncology. 2022; 33(S3):S149- 150, ESMO Abstract #060, Abstract

2021

Molecular plasticity of luminal breast cancer and response to CDK 4/6 inhibition – The biomarker program of the PENELOPE-B trial investigating post-neoadjuvant palbociclib.

Denkert C, Marme F, Marin M, Untch M, Bonnefoi H, Kim S-B, Bear H, Witkiewicz A, Im S-A, DeMichele A, Van’t Veer L, McCarthy N, Steiwe T, Gelmon KA, Garcia-Saenz JA, Kelly CM, Reimer T, Knudsen E, Turner N, Rojo F, Fasching PA, Teply-Szymanski J, Liu Y, Toi M, Rugo HS, Gnant M, Makris A, Felder B, Weber K, Loible S. SABCS 2021; PD2-04, Abstract

Germline BRCA1/2 and other predisposition genes in high-risk early-stage HR+/HER2- breast cancer (BC) patients treated with endocrine therapy (ET) with or without palbociclib: A secondary analysis from the PENELOPE-B study.

Loibl S, Hauke J, Gelmon K, Marme F, Ernst C, Martin M, Untch M, Bonnefoi H, Knudsen E, Im S-A, DeMidhele A, Van’t Veer L, Kim S-B, Bear H, McCarthy N, Turner N, Witkiewicz A, Rojo F, Faschin PA, Carcia-Saenz JA, Kelly CM, Reimer T, Toi M, Rugo H, Denkert C, Gnant M, Makris A, Liu Y, Valota O, Felder B, Wever K, Nekljudova V, Hahnen E. SABCS 2021; P5-13-36, Abstract