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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.
Awan, Arif; Ng, Terry; Conter, Henry; Raskin, William; Stober, Carol; Simos, Demetrios; Pond, Greg; Dhesy-Thind, Sukhbinder; Mates, Mihaela; Kumar, Vikaash; Fergusson, Dean; Hutton, Brian; Saunders, Deanna; Vandermeer, Lisa; Clemons, Mark.
Afiliación
  • Awan A; Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, Ottawa, Canada.
  • Ng T; Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.
  • Conter H; Department of Medicine, Division of Medical Oncology, The Ottawa Hospital and University of Ottawa, Ottawa, Canada.
  • Raskin W; Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.
  • Stober C; William Osler Cancer Centre and Department of Oncology, University of Western Ontario, Brampton, Canada.
  • Simos D; William Osler Cancer Centre and Department of Oncology, University of Western Ontario, Brampton, Canada.
  • Pond G; Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.
  • Dhesy-Thind S; Stronach Regional Cancer Center, Newmarket, Canada.
  • Mates M; Department of Oncology, Juravinski Hospital and Cancer Centre and McMaster University, Hamilton, Canada.
  • Kumar V; Department of Oncology, Juravinski Hospital and Cancer Centre and McMaster University, Hamilton, Canada.
  • Fergusson D; Cancer Centre of Southeastern Ontario, Kingston, Canada.
  • Hutton B; Markham Stouffville Hospital, Shakir Rehmatullah Cancer Clinic, Markham, Canada.
  • Saunders D; Clinical Epidemiology Program, The Ottawa Hospital Research Institute and University of Ottawa, Ottawa, Canada.
  • Vandermeer L; Clinical Epidemiology Program, The Ottawa Hospital Research Institute and University of Ottawa, Ottawa, Canada.
  • Clemons M; Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.
J Bone Oncol ; 26: 100343, 2021 Feb.
Article en En | MEDLINE | ID: mdl-33425673
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials Idioma: En Revista: J Bone Oncol Año: 2021 Tipo del documento: Article País de afiliación: Canadá Pais de publicación: Países Bajos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials Idioma: En Revista: J Bone Oncol Año: 2021 Tipo del documento: Article País de afiliación: Canadá Pais de publicación: Países Bajos