A Randomized, Open-label, Presurgical, Window-of-Opportunity Study Comparing the Pharmacodynamic Effects of the Novel Oral SERD AZD9496 with Fulvestrant in Patients with Newly Diagnosed ER+ HER2(-) Primary Breast Cancer

Robertson JFR, Evans A, Henschen S, Kirwan CC, Jahan A, Kenny LM, Dixon JM, Schmid P, Kothari A, Mohamed O, Fasching P, Cheung KL, Wuerstlein R, Carroll D, Klinowska T, Lindemann JPO, Macdonald A, Mather R, Maudsley R, Moschetta M, Nikolaou M, Roudier MP, Sarvotham T, Schiavon G, Zhou D, Zhou L, Harbeck N (2020)

Publication Type: Journal article

Publication year: 2020

Journal

Clinical Cancer Research American Association for Cancer Research

Book Volume: 26

Pages Range: 4242-4249

Journal Issue: 16

DOI: 10.1158/1078-0432.CCR-19-3387

Abstract

Purpose: Fulvestrant, the first-in-class selective estrogen receptor (ER) degrader (SERD), is clinically effective in patients with ER+ breast cancer, but it has administration and pharmacokinetic limitations. Pharmacodynamic data suggest complete ER degradation is not achieved at fulvestrant's clinically feasible dose. This presurgical study (NCT03236974) compared the pharmacodynamic effects of fulvestrant with AZD9496, a novel, orally bioavailable, nonsteroidal, potent SERD, in treatment-naive patients with ER+ HER2(-) primary breast cancer awaiting curative intent surgery.

Authors with CRIS profile

Peter Fasching Professur für Translationale Frauenheilkunde und Geburtshilfe

Involved external institutions

University of Nottingham

United Kingdom (GB) Poole Hospital NHS Foundation Trust

United Kingdom (GB) HELIOS Kliniken

Germany (DE) University of Manchester

United Kingdom (GB) King's Mill Hospital

United Kingdom (GB) Imperial College London / The Imperial College of Science, Technology and Medicine

United Kingdom (GB) Western General Hospital

United Kingdom (GB) Queen Mary University of London

United Kingdom (GB) Guy's and St Thomas' (NHS Foundation Trust)

United Kingdom (GB) Johannes Wesling Klinikum Minden

Germany (DE) Ludwig-Maximilians-Universität (LMU)

Germany (DE) AstraZeneca UK Limited

United Kingdom (GB)

How to cite

APA:

Robertson, J.F.R., Evans, A., Henschen, S., Kirwan, C.C., Jahan, A., Kenny, L.M.,... Harbeck, N. (2020). A Randomized, Open-label, Presurgical, Window-of-Opportunity Study Comparing the Pharmacodynamic Effects of the Novel Oral SERD AZD9496 with Fulvestrant in Patients with Newly Diagnosed ER+ HER2(-) Primary Breast Cancer. Clinical Cancer Research, 26(16), 4242-4249. https://doi.org/10.1158/1078-0432.CCR-19-3387

MLA:

Robertson, John F. R., et al. "A Randomized, Open-label, Presurgical, Window-of-Opportunity Study Comparing the Pharmacodynamic Effects of the Novel Oral SERD AZD9496 with Fulvestrant in Patients with Newly Diagnosed ER+ HER2(-) Primary Breast Cancer." Clinical Cancer Research 26.16 (2020): 4242-4249.

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