Comparing a Single-Dose vs. Twice Yearly Zoledronate in Patients With Early Stage Breast Cancer (REaCT-ZOL)

NCT03664687 | Completed Phase 4 DMC

• 1 other identifier: OTT 18-01
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 6

Brief Summary

REaCT ZOL will compare one 4 mg dose of Zoledronate vs. one 4 mg dose of Zoledronate given every 6 months for 3 years.

Conditions

Early-stage Breast Cancer

Keywords

Adjuvant Zoledronate

Outcome Measures

Primary Outcomes (4)

• Multiple Site Activation

  Evaluating the feasibility of multiple site activation. Measured by the number of sites activated, as well as how long it takes to get the sites activated once the first site becomes active for accrual.

  12 months

• Time to Activate Six Sites

  Evaluating the amount of time it takes to get six sites activated for participant accrual.

  12 months

• Medical Oncologist Active Participation

  Evaluating the number of medical oncologists at each study site who actively participate in the trial. Active participation includes approaching eligible patients for the study, as well as following up with patients who are taking part in the study.

  Through to end of accrual, average 2 years

• Patient Enrollment

  Evaluating the number of patients enrolled across all of the active sites within 9 months of the sixth site being activated. Number of patients enrolled across all of the active sites.

  9 months

Secondary Outcomes (5)

• Bone-Metastasis-Free Survival

  Through to end of study, average of 3 years

• Time to first bone metastasis

  Through to end of study, average of 3 years

• Fragility fractures rates

  Through to end of study, average of 3 years

• Direct Estimation of Health Utility Values

  Through to end of study, average of 3 years

• Incremental Cost-Effectiveness Ratio

  Through to study completion, an average of 3 years

Study Arms (2)

Zoledronate one dose (4 mg)

ACTIVE COMPARATOR

One 4 mg dose of Zoledronate

Drug: Zoledronate

Zoledronate 4 mg every 6 months x 3 years

ACTIVE COMPARATOR

One 4 mg dose of Zoledronate given every 6 months for 3 years

Drug: Zoledronate

Interventions

Zoledronate DRUG

Administered intravenously (IV)

Also known as: Zoledronic acid

Zoledronate 4 mg every 6 months x 3 years; Zoledronate one dose (4 mg)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Commencing zoledronate within 3 months of starting neoadjuvant or adjuvant endocrine therapy or within 3 months of completion of neoadjuvant or adjuvant chemotherapy for early stage breast cancer
• Patients receiving any intravenous or oral biphosphonates, or subcutaneous denosumab for the treatment of osteoporosis must discontinue treatment prior to baseline evaluation
• ECOG performance status equal or less than 2 and life expectancy of more than 12 months
• Serum creatinine greater than 30 ml/min and corrected serum calcium equal or greater than 2 mmol/l within 4 weeks before first zoledronate infusion
• Age equal or greater than 18 years
• Able to provide written consent

You may not qualify if:

• Metastatic disease
• History of osteonecrosis of the jaw
• Known hypersensitivity to trial drug or hypersensitivity to any other component of the trial drug (e.g. fructose)
• Any psychological, familial, sociological or geographical condition potentially hampering compliance with the trial protocol
• Pregnancy or risk of pregnancy (this includes participants that are not willing to practice active contraception for the duration of the study)\* \*Women/men of child bearing potential must have agreed to use two effective contraceptive methods while on study. A women is considered to be of 'childbearing potential' if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods. 'effective contraception' also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as complete hysterectomy, bilateral oophorectomy or bilateral tubal ligation, or vasectomy/vasectomized partner. However, if at any point a previously celibate participant chooses to become heterosexually active during the period for use of contraceptive measures outlined in the protocol, she is responsible for beginning contraceptive measures. Examples of effective methods of contraception: Male condom plus spermicide; Cap plus spermicide; Diaphragm plus spermicide; intrauterine device (Copper T, Progesterone T; Levonorgestrel-releasing intrauterine system (i.e. Mirena); hormonal methods (implants, hormonal shot or injection, combined pill, minipill, patch).

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (6)

William Osler Health System, Brampton Civic Hospital

Brampton, Ontario, L6R 3J7, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Location

Markham Stouffville Hospital

Markham, Ontario, L3P 7P3, Canada

Location

Southlake Regional Health Centre

Newmarket, Ontario, L3Y 2P9, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8M2, Canada

Location

Related Publications (3)

• Awan A, Ng T, Conter H, Raskin W, Stober C, Simos D, Pond G, Dhesy-Thind S, Mates M, Kumar V, Fergusson D, Hutton B, Saunders D, Vandermeer L, Clemons M; REaCT Investigators. 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. J Bone Oncol. 2020 Dec 13;26:100343. doi: 10.1016/j.jbo.2020.100343. eCollection 2021 Feb.

  PMID: 33425673 BACKGROUND

• McGee S, Alzahrani M, Vandermeer L, Cole K, Larocque G, Awan A, Hutton B, Pond G, Saunders D, Clemons M. Adjuvant bisphosphonate use in patients with early stage breast cancer: a physician survey. Breast Cancer Res Treat. 2021 Jun;187(2):477-486. doi: 10.1007/s10549-021-06147-1. Epub 2021 Mar 23.

  PMID: 33755864 BACKGROUND

• McGee S, AlZahrani M, Stober C, Ng TL, Cole K, Larocque G, Awan A, Sehdev S, Hilton J, Vandermeer L, Hutton B, Pond G, Saunders D, Clemons M. Adjuvant bisphosphonate use in patients with early stage breast cancer: Patient perspectives on treatment acceptability and potential de-escalation. J Bone Oncol. 2021 Feb 19;27:100351. doi: 10.1016/j.jbo.2021.100351. eCollection 2021 Apr.

  PMID: 33680749 BACKGROUND

Related Links

• The Rethinking Clinical Trials (REaCT) website

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mark Clemons, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 10, 2018
• Study Start: October 31, 2018
• Primary Completion: April 2, 2020
• Study Completion: March 28, 2025
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

CA (6)