A Phase II Study of Abemaciclib in Patients with Brain Metastases Secondary to Hormone Receptor-Positive Breast Cancer.

Clinical Cancer Research : an Official Journal of the American Association for Cancer Research
S M TolaneyCarey K Anders

Abstract

The primary objective was to evaluate intracranial objective response rate (iORR) in patients receiving abemaciclib with brain or leptomeningeal metastases (LM) secondary to hormone receptor-positive (HR+) metastatic breast cancer (MBC). Secondary objectives evaluated extracranial response, abemaciclib pharmacokinetics, brain metastases tissue exposure, and safety. This nonrandomized, phase II study (NCT02308020) enrolled patients in tumor subtype-specific cohorts A-D: A (HR+, HER2- MBC), B (HR+, HER2+ MBC), C (HR+ MBC LM), and D (brain metastases surgical resection). Abemaciclib 200 mg was administered twice daily as monotherapy or with endocrine therapy, or 150 mg twice daily with trastuzumab. Cohorts A and B used a Simon two-stage design. In cohort A (n = 58), 3 patients were confirmed responders resulting in an iORR of 5.2% [95% confidence interval (CI), 0.0-10.9], and the intracranial clinical benefit rate (iCBR) was 24% (95% CI, 13.1-35.2). Median overall survival (OS) was 12.5 months (95% CI, 9.3-16.4). A volumetric decrease in target intracranial lesions was experienced by 38% of patients. In cohort B (n = 27), there were no confirmed intracranial responses. An iCBR of 11% (95% CI, 0.0-23.0) was observed. Median OS was ...Continue Reading

References

Oct 11, 2005·Journal of Neuro-oncology·Igor T Gavrilovic, Jerome B Posner
Mar 17, 2007·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·John F Deeken, Wolfgang Löscher
Aug 4, 2007·The Oncologist·April F Eichler, Jay S Loeffler
Apr 19, 2008·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Nancy U LinEric P Winer
Dec 23, 2008·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·E A EisenhauerJ Verweij
Feb 21, 2009·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Nancy U LinEric P Winer
Feb 11, 2010·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Said AkliKhandan Keyomarsi
Dec 3, 2011·Breast Cancer Research : BCR·Barbara AdamoCarey K Anders
Dec 29, 2011·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Paul W SperdutoMinesh Mehta
Dec 4, 2013·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Nancy U LinPatricia S Steeg
Jul 14, 2014·Radiation Oncology·Carsten NiederLaurie E Gaspar
Jun 13, 2015·The Lancet Oncology·Nancy U LinUNKNOWN Response Assessment in Neuro-Oncology (RANO) group
Jun 11, 2016·Expert Opinion on Drug Metabolism & Toxicology·Hampig Raphael KourieAhmad Awada
Jan 1, 2017·Neuro-oncology·Marc ChamberlainKurt A Jaeckle
May 24, 2017·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Maura N DicklerJosé Baselga
Jun 6, 2017·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·George W SledgeAntonio Llombart-Cussac
Oct 3, 2017·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Matthew P GoetzAngelo Di Leo
Jul 23, 2018·Annals of Oncology : Official Journal of the European Society for Medical Oncology·F CardosoE P Winer
Mar 13, 2019·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Rachel A FreedmanUNKNOWN Translational Breast Cancer Research Consortium
Jun 25, 2019·ESMO Open·Emilie Le RhunMichael Weller
Jul 30, 2019·Critical Reviews in Oncology/hematology·Jonathan W RickManish K Aghi
Oct 1, 2018·Annals of Oncology : Official Journal of the European Society for Medical Oncology·H S RugoM P Goetz

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Citations

Dec 1, 2020·British Journal of Cancer·Caroline BailleuxThomas Bachelot
Nov 18, 2020·International Journal of Molecular Sciences·Alessia PellerinoRoberta Rudà
Mar 3, 2021·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Sara M TolaneyCarey K Anders
Mar 21, 2021·Journal of Neuro-oncology·Matthew N MillsKamran A Ahmed
May 7, 2021·Oncotarget·Ilana Schlam, Sara M Tolaney
Jun 29, 2021·Expert Review of Anticancer Therapy·Komal JhaveriGeoffrey I Shapiro
Jul 31, 2021·Frontiers in Oncology·Mridula A GeorgeShridar Ganesan
Aug 9, 2021·Annals of Oncology : Official Journal of the European Society for Medical Oncology·E Le RhunUNKNOWN EANO Executive Board and ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org
Aug 18, 2021·Clinical Drug Investigation·Vincenzo Di NunnoAlba Ariela Brandes
Aug 24, 2021·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Philipp KarschniaJoerg-Christian Tonn

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