PENELOPE-B

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Official title

Phase III Study Evaluating Palbociclib (PD-0332991), a Cyclin-Dependent Kinase (CDK) 4/6 Inhibitor in Patients With Hormone-receptor-positive, HER2-normal Primary Breast Cancer With High Relapse Risk After Neoadjuvant Chemotherapy "PENELOPEB"

Phase

Phase 3

Status

Completed

Conditions

Breast Cancer; Hormonreceptor Positive; Her2-normal; Postneoadjuvant Treatment With CDK 4/6 Inhibitor; CPS-EG Score

Interventions

Palbociclib PD-0332991; Placebo

Arms

• Palbociclib · Experimental
• Placebo · Placebo comparator

Enrollment

1,250

Primary outcomes

• Invasive Disease Free Survival (iDFS) for Palbociclib vs. Placebo in Patients With High CPS-EG Score After Neoadjuvant Chemotherapy Receiving Standard Adjuvant Endocrine Therapy for HR-positive/HER2-normal Primary Breast Cancer.

Sponsor

GBG Forschungs GmbH with Pfizer, AGO Study Group, NSABP Foundation Inc, Breast International Group

Start

Oct 30, 2013

Primary completion

Aug 24, 2020

Results posted

Yes

Registry record

NCT01864746 · updated Dec 12, 2023

• Mittendorf EA, Jeruss JS, Tucker SL, Kolli A, Newman LA, Gonzalez-Angulo AM, Buchholz TA, Sahin AA, Cormier JN, Buzdar AU, Hortobagyi GN, Hunt KK. Validation of a novel staging system for disease-specific survival in patients with breast cancer treated with neoadjuvant chemotherapy. J Clin Oncol. 2011 May 20;29(15):1956-62. doi: 10.1200/JCO.2010.31.8469. Epub 2011 Apr 11. PubMed 21482989
• Musgrove EA, Caldon CE, Barraclough J, Stone A, Sutherland RL. Cyclin D as a therapeutic target in cancer. Nat Rev Cancer. 2011 Jul 7;11(8):558-72. doi: 10.1038/nrc3090. PubMed 21734724
• ENCODE Project Consortium. An integrated encyclopedia of DNA elements in the human genome. Nature. 2012 Sep 6;489(7414):57-74. doi: 10.1038/nature11247. PubMed 22955616
• Finn RS, Dering J, Conklin D, Kalous O, Cohen DJ, Desai AJ, Ginther C, Atefi M, Chen I, Fowst C, Los G, Slamon DJ. PD 0332991, a selective cyclin D kinase 4/6 inhibitor, preferentially inhibits proliferation of luminal estrogen receptor-positive human breast cancer cell lines in vitro. Breast Cancer Res. 2009;11(5):R77. doi: 10.1186/bcr2419. PubMed 19874578
• Symmans WF, Peintinger F, Hatzis C, Rajan R, Kuerer H, Valero V, Assad L, Poniecka A, Hennessy B, Green M, Buzdar AU, Singletary SE, Hortobagyi GN, Pusztai L. Measurement of residual breast cancer burden to predict survival after neoadjuvant chemotherapy. J Clin Oncol. 2007 Oct 1;25(28):4414-22. doi: 10.1200/JCO.2007.10.6823. Epub 2007 Sep 4. PubMed 17785706
• Mauri D, Pavlidis N, Ioannidis JP. Neoadjuvant versus adjuvant systemic treatment in breast cancer: a meta-analysis. J Natl Cancer Inst. 2005 Feb 2;97(3):188-94. doi: 10.1093/jnci/dji021. PubMed 15687361
• von Minckwitz G, Untch M, Blohmer JU, Costa SD, Eidtmann H, Fasching PA, Gerber B, Eiermann W, Hilfrich J, Huober J, Jackisch C, Kaufmann M, Konecny GE, Denkert C, Nekljudova V, Mehta K, Loibl S. Definition and impact of pathologic complete response on prognosis after neoadjuvant chemotherapy in various intrinsic breast cancer subtypes. J Clin Oncol. 2012 May 20;30(15):1796-804. doi: 10.1200/JCO.2011.38.8595. Epub 2012 Apr 16. PubMed 22508812
• Loibl S, Marme F, Martin M, Untch M, Bonnefoi H, Kim SB, Bear H, McCarthy N, Mele Olive M, Gelmon K, Garcia-Saenz J, Kelly CM, Reimer T, Toi M, Rugo HS, Denkert C, Gnant M, Makris A, Koehler M, Huang-Bartelett C, Lechuga Frean MJ, Colleoni M, Werutsky G, Seiler S, Burchardi N, Nekljudova V, von Minckwitz G. Palbociclib for Residual High-Risk Invasive HR-Positive and HER2-Negative Early Breast Cancer-The Penelope-B Trial. J Clin Oncol. 2021 May 10;39(14):1518-1530. doi: 10.1200/JCO.20.03639. Epub 2021 Apr 1. PubMed 33793299
• Denkert C, Rachakonda S, Pehl A, Marme F, Martin M, Karn T, Untch M, Bonnefoi H, Kim SB, Hirmas N, Bear H, Witkiewicz AK, Im SA, DeMichele A, Van't Veer L, McCarthy N, Stiewe T, Jank P, Gelmon KA, Garcia-Saenz JA, Westhoff C, Kelly CM, Reimer T, Olive MM, Knudsen ES, van Mackelenbergh M, Rojo F, Frickel N, Fasching PA, Teply-Szymanski J, Toi M, Rugo HS, Gnant M, Makris A, Felder B, Nekljudova V, Loibl S. Clinical and Molecular Evaluation of HER2-Low and HER2-Ultralow Breast Cancer in the Penelope-B Clinical Trial Cohort. Mod Pathol. 2026 Jun;39(6):101006. doi: 10.1016/j.modpat.2026.101006. Epub 2026 Apr 21. PubMed 42025846
• Hahnen E, Hauke J, Gelmon K, Marme F, Ernst C, Martin M, Untch M, Bonnefoi H, Knudsen E, Im SA, DeMichele A, Van't Veer L, Kim SB, Bear H, McCarthy N, Rhiem K, Turner N, Witkiewicz A, Rojo F, Filipits M, Martin LA, Fasching PA, Schem C, Becker K, Garcia-Saenz JA, Kelly CM, Reimer T, Toi M, Rugo HS, Denkert C, Gnant M, Makris A, Liu Y, Valota O, Felder B, Weber K, Nekljudova V, Loibl S. BRCA1/2 and Other Predisposition Genes in High-Risk Hormone Receptor+/Human Epidermal Growth Factor Receptor 2- Breast Cancer Treated With Endocrine Therapy With or Without Palbociclib: A Secondary PENELOPE-B Study Analysis. JCO Precis Oncol. 2025 Apr;9:e2400742. doi: 10.1200/PO-24-00742. Epub 2025 Apr 10. PubMed 40209141