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Bisphosphonate

Zoledronate Dosing for Breast Cancer (REaCT-ZOL Trial)

Phase 4

Waitlist Available

Led By Mark Clemons, MD

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through to end of study, average of 3 years

Awards & highlights

REaCT-ZOL Trial Summary

This trial will compare the effects of two different doses of Zoledronate given over a 3 year period.

Who is the study for?

This trial is for adults over 18 with early stage breast cancer, starting treatment or within 3 months post-chemotherapy. Participants need functioning kidneys, normal calcium levels, and a life expectancy over a year. They must not be pregnant or at risk of pregnancy without using two effective contraceptives unless surgically sterile.Check my eligibility

What is being tested?

The REaCT-ZOL study is testing the effectiveness of Zoledronate given as a single dose versus every six months for three years in patients with early stage breast cancer to see which dosing schedule works better.See study design

What are the potential side effects?

Zoledronate may cause side effects such as flu-like symptoms, pain in bones or muscles or joints, nausea and vomiting, kidney issues, low calcium levels in the blood, and rarely osteonecrosis of the jaw.

REaCT-ZOL Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not currently taking any medications for osteoporosis.

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I can care for myself and doctors expect me to live more than a year.

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I am 18 years old or older.

REaCT-ZOL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through to end of study, average of 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through to end of study, average of 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through to end of study, average of 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Medical Oncologist Active Participation

Multiple Site Activation

Patient Enrollment

+1 more

Secondary outcome measures

Bone-Metastasis-Free Survival

Direct Estimation of Health Utility Values

Fragility fractures rates

+2 more

REaCT-ZOL Trial Design

2Treatment groups

Active Control

Group I: Zoledronate one dose (4 mg)Active Control1 Intervention

One 4 mg dose of Zoledronate

Group II: Zoledronate 4 mg every 6 months x 3 yearsActive Control1 Intervention

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor

561 Previous Clinical Trials

2,785,480 Total Patients Enrolled

35 Trials studying Breast Cancer

5,261 Patients Enrolled for Breast Cancer

Mark Clemons, MDPrincipal InvestigatorOttawa Hospital Research Institute

10 Previous Clinical Trials

1,997 Total Patients Enrolled

5 Trials studying Breast Cancer

823 Patients Enrolled for Breast Cancer

Media Library

Breast Cancer Clinical Trial 2023: Zoledronate Highlights & Side Effects. Trial Name: NCT03664687 — Phase 4

Zoledronate (Bisphosphonate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03664687 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could individuals currently enroll in this trial?

"Unfortunately, this study is no longer accepting participants. The trial was first made available on October 31st 2018 and its last update occurred on April 19th 2022. If you are searching for other research opportunities, there are 2290 studies recruiting breast cancer patients and 36 trials enrolling those who require Zoledronate 4 mg every 6 months over 3 years of treatment."

Answered by AI

Has research been conducted to evaluate the efficacy of administering Zoledronate 4 mg every 6 months for a period of 3 years?

"At this time, there are 36 ongoing clinical trials for Zoledronate 4 mg every 6 months x 3 years with 8 in Phase III. Douliu, Yunlin County is hosting several of the investigations; however, a total of 694 medical centres across the world are engaging with research concerning Zoledronate 4 mg every 6 months x 3 years."

Answered by AI

How many people have signed up to take part in this research endeavor?

"This particular study is not currently taking on new participants. It was first posted in October of 2018 and the last update happened in April 2022. If you are interested, there are 2290 clinical trials for breast cancer patients and 36 studies examining Zoledronate 4 mg every 6 months x 3 years that require volunteers."

Answered by AI

Could you give me a sense of the risks associated with administering Zoledronate 4 mg every 6 months for three years?

"Thanks to the completion of a Phase 4 trial, we can confidently assign Zoledronate 4 mg every 6 months x 3 years with a safety score of 3."

Answered by AI

What therapeutic uses is Zoledronate 4 mg every 6 months x 3 years commonly administered for?

"Zoledronate 4 mg can be administered every 6 months for 3 years in order to address solid tumors, bone mineral density issues and chemotherapy."

Answered by AI

What are the core aims of this investigation?

"This prospective trial, to be observed over 12 months, aims to complete Multiple Site Activation. Secondary goals include Bone-Metastasis-Free Survival (Bone-DFS), Time To First Bone Metastasis and Incremental Cost Effectiveness Ratio evaluations."

Answered by AI

Recent research and studies

Journal of Bone OncologyJournal

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, Terry Ng, Henry Conter, William Raskin, Carol Stober, Demetrios Simos, Greg Pond, et al.. 2021. “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. Elsevier BV. doi:10.1016/j.jbo.2020.100343.

clinicaltrials.govStudy

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

2018. "Comparing a Single-Dose vs. Twice Yearly Zoledronate in Patients With Early Stage Breast Cancer (REaCT-ZOL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03664687.