Feasibility outcomes of a randomised, multicentre, pilot trial comparing standard 6-monthly dosing of adjuvant zoledronate with a single one-time dose in patients with early stage breast cancer

Background: Adjuvant zoledronate is widely used in patients with early stage breast cancer (EBC), but its optimal duration and dosing interval is still unknown. While a single-dose of zoledronate can improve bone density for many years, a proper evaluation of its effects on breast cancer-related out...

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Main Authors: Arif Awan, Terry Ng, Henry Conter, William Raskin, Carol Stober, Demetrios Simos, Greg Pond, Sukhbinder Dhesy-Thind, Mihaela Mates, Vikaash Kumar, Dean Fergusson, Brian Hutton, Deanna Saunders, Lisa Vandermeer, Mark Clemons
Format: Article
Language:English
Published: Elsevier 2021-02-01
Series:Journal of Bone Oncology
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S2212137420300981
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spelling doaj-9cbee11243204b0a8c3c062e7a1485a92021-03-01T04:14:59ZengElsevierJournal of Bone Oncology2212-13742021-02-0126100343Feasibility outcomes of a randomised, multicentre, pilot trial comparing standard 6-monthly dosing of adjuvant zoledronate with a single one-time dose in patients with early stage breast cancerArif Awan0Terry Ng1Henry Conter2William Raskin3Carol Stober4Demetrios Simos5Greg Pond6Sukhbinder Dhesy-Thind7Mihaela Mates8Vikaash Kumar9Dean Fergusson10Brian Hutton11Deanna Saunders12Lisa Vandermeer13Mark Clemons14Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, Ottawa, Canada; Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, CanadaDepartment of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, Ottawa, Canada; Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, CanadaWilliam Osler Cancer Centre and Department of Oncology, University of Western Ontario, Brampton, CanadaWilliam Osler Cancer Centre and Department of Oncology, University of Western Ontario, Brampton, CanadaCancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, CanadaStronach Regional Cancer Center, Newmarket, CanadaDepartment of Oncology, Juravinski Hospital and Cancer Centre and McMaster University, Hamilton, CanadaDepartment of Oncology, Juravinski Hospital and Cancer Centre and McMaster University, Hamilton, CanadaCancer Centre of Southeastern Ontario, Kingston, CanadaMarkham Stouffville Hospital, Shakir Rehmatullah Cancer Clinic, Markham, CanadaClinical Epidemiology Program, The Ottawa Hospital Research Institute and University of Ottawa, Ottawa, CanadaClinical Epidemiology Program, The Ottawa Hospital Research Institute and University of Ottawa, Ottawa, CanadaCancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, CanadaCancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, CanadaDepartment of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, Ottawa, Canada; Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada; Corresponding author at: Division of Medical Oncology, The Ottawa Hospital Cancer Centre, 501 Smyth Road, Ottawa, Canada.Background: Adjuvant zoledronate is widely used in patients with early stage breast cancer (EBC), but its optimal duration and dosing interval is still unknown. While a single-dose of zoledronate can improve bone density for many years, a proper evaluation of its effects on breast cancer-related outcomes would require a large trial. In this pilot study we evaluated the feasibility of performing such a trial. Methods: Eligible patients with EBC were randomised to receive either one dose of zoledronate or 7 doses (6-monthly dosing for 3 years). Feasibility was assessed by a combination of primary outcomes including: activation of at least 6 Ontario sites within a year, active participation (i.e. approaching eligible patients for study participation) of at least half of the medical oncologists, and enrolment of at least 100 patients across all sites within 9 months of the sixth site being activated. Results: All 6 sites were activated within 1 year and of 47 medical oncologists, 27 (57%) approached patients. Between November 2018 and April 2020, 211 eligible patients were randomised, 106 (50.2%) to a single dose of zoledronate and 105 (49.8%) to 6-monthly dosing. Baseline characteristics of randomised patients included; median age 59 (range 36–88), ER and/or PR positive (85%), Her2 positive (23%), menopausal status (premenopausal [19%], perimenopausal [6.7%] and postmenopausal [74%]) and 74% received neo/adjuvant chemotherapy. Conclusions: All study feasibility endpoints were met in this trial comparing alternative schedules for adjuvant zoledronate. We will now seek funding for performing a larger efficacy trial.Trial registration: NCT03664687.http://www.sciencedirect.com/science/article/pii/S2212137420300981Breast cancerZoledronateAdjuvant bisphosphonate
collection DOAJ
language English
format Article
sources DOAJ
author Arif Awan
Terry Ng
Henry Conter
William Raskin
Carol Stober
Demetrios Simos
Greg Pond
Sukhbinder Dhesy-Thind
Mihaela Mates
Vikaash Kumar
Dean Fergusson
Brian Hutton
Deanna Saunders
Lisa Vandermeer
Mark Clemons
spellingShingle Arif Awan
Terry Ng
Henry Conter
William Raskin
Carol Stober
Demetrios Simos
Greg Pond
Sukhbinder Dhesy-Thind
Mihaela Mates
Vikaash Kumar
Dean Fergusson
Brian Hutton
Deanna Saunders
Lisa Vandermeer
Mark Clemons
Feasibility outcomes of a randomised, multicentre, pilot trial comparing standard 6-monthly dosing of adjuvant zoledronate with a single one-time dose in patients with early stage breast cancer
Journal of Bone Oncology
Breast cancer
Zoledronate
Adjuvant bisphosphonate
author_facet Arif Awan
Terry Ng
Henry Conter
William Raskin
Carol Stober
Demetrios Simos
Greg Pond
Sukhbinder Dhesy-Thind
Mihaela Mates
Vikaash Kumar
Dean Fergusson
Brian Hutton
Deanna Saunders
Lisa Vandermeer
Mark Clemons
author_sort Arif Awan
title Feasibility outcomes of a randomised, multicentre, pilot trial comparing standard 6-monthly dosing of adjuvant zoledronate with a single one-time dose in patients with early stage breast cancer
title_short Feasibility outcomes of a randomised, multicentre, pilot trial comparing standard 6-monthly dosing of adjuvant zoledronate with a single one-time dose in patients with early stage breast cancer
title_full Feasibility outcomes of a randomised, multicentre, pilot trial comparing standard 6-monthly dosing of adjuvant zoledronate with a single one-time dose in patients with early stage breast cancer
title_fullStr Feasibility outcomes of a randomised, multicentre, pilot trial comparing standard 6-monthly dosing of adjuvant zoledronate with a single one-time dose in patients with early stage breast cancer
title_full_unstemmed Feasibility outcomes of a randomised, multicentre, pilot trial comparing standard 6-monthly dosing of adjuvant zoledronate with a single one-time dose in patients with early stage breast cancer
title_sort feasibility outcomes of a randomised, multicentre, pilot trial comparing standard 6-monthly dosing of adjuvant zoledronate with a single one-time dose in patients with early stage breast cancer
publisher Elsevier
series Journal of Bone Oncology
issn 2212-1374
publishDate 2021-02-01
description Background: Adjuvant zoledronate is widely used in patients with early stage breast cancer (EBC), but its optimal duration and dosing interval is still unknown. While a single-dose of zoledronate can improve bone density for many years, a proper evaluation of its effects on breast cancer-related outcomes would require a large trial. In this pilot study we evaluated the feasibility of performing such a trial. Methods: Eligible patients with EBC were randomised to receive either one dose of zoledronate or 7 doses (6-monthly dosing for 3 years). Feasibility was assessed by a combination of primary outcomes including: activation of at least 6 Ontario sites within a year, active participation (i.e. approaching eligible patients for study participation) of at least half of the medical oncologists, and enrolment of at least 100 patients across all sites within 9 months of the sixth site being activated. Results: All 6 sites were activated within 1 year and of 47 medical oncologists, 27 (57%) approached patients. Between November 2018 and April 2020, 211 eligible patients were randomised, 106 (50.2%) to a single dose of zoledronate and 105 (49.8%) to 6-monthly dosing. Baseline characteristics of randomised patients included; median age 59 (range 36–88), ER and/or PR positive (85%), Her2 positive (23%), menopausal status (premenopausal [19%], perimenopausal [6.7%] and postmenopausal [74%]) and 74% received neo/adjuvant chemotherapy. Conclusions: All study feasibility endpoints were met in this trial comparing alternative schedules for adjuvant zoledronate. We will now seek funding for performing a larger efficacy trial.Trial registration: NCT03664687.
topic Breast cancer
Zoledronate
Adjuvant bisphosphonate
url http://www.sciencedirect.com/science/article/pii/S2212137420300981
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