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Breast CancerPhase 4REaCT-BTANCT02721433

4-weekly Versus 12-weekly Administration of Bone-targeted Agents in Patients With Bone Metastases

A Phase 4 study testing Pamidronate, Denosumab and Zoledronate in people with Breast Cancer and Prostate Cancer, run by Ottawa Hospital Research Institute at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The current Rethinking Clinical Trials (REaCT) trial will compare two schedules(12- vs. 4-weekly) of bone-targeting agents (BTAs) to evaluate quality of life, pain and skeletal events within the Canadian Health Care System. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Breast Cancer, Prostate Cancer, Metastasis
What is being tested?
Pamidronate, Denosumab and Zoledronate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
263 participants
Where
1 siteCanada
Study dates
Aug 2016to Apr 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with either radiologically and/or histologically confirmed bone metastases from castrate resistant prostate cancer (36) or breast cancer.
  • About to start or currently receiving BTA therapy.
  • Serum creatinine >30 ml/min and corrected serum calcium ≥ 2 mmol/l
  • Age ≥ 18 years.
  • Able to provide verbal consent

Who cannot join

  • For CRPC patients - Definite contraindication for denosumab at baseline (e.g. hypocalcaemia [Albumin-corrected serum calcium < 2.0 mmol/l]).
  • History of or current evidence of osteonecrosis of the jaw.
  • Radiotherapy or surgery to the bone planned within 4 weeks after randomization.
  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • The Ottawa Hospital Research Institute

    Ottawa, Ontario

Other trials in Canada

About this study

Official title: A Pragmatic Randomised, Multicentre Trial Comparing 4-weekly Versus 12-weekly Administration of Bone-targeted Agents in Patients With Bone Metastases From Either Castration-resistant Prostate Cancer or Breast Cancer - The REaCT-BTA Study

The current Rethinking Clinical Trials (REaCT) trial will compare two schedules(12- vs. 4-weekly) of bone-targeting agents (BTAs) to evaluate quality of life, pain and skeletal events within the Canadian Health Care System. This study will use an "integrated consent model" that involves "oral consent" rather than a written informed consent writing process as the study is comparing standard schedules and not a new administration schedule.

Read the detailed description

Bone metastases are common in patients with advanced breast and prostate cancers. Skeletal metastases can be associated with reduced Quality of Life (QoL), pain and skeletal-related events (SREs) (defined as pathological fractures, surgery/radiotherapy to bone, spinal cord compression and hypercalcaemia). Maintaining QoL while avoiding or delaying SREs are the main goals of therapy. Patients therefore receive bone-targeted agents (e.g. pamidronate, zoledronate and denosumab) which are typically given every 4 weeks. However, this 4 week dosing is based on convenience so the treatment could be given concurrently with chemotherapy. The half-life of these drugs in the bone is many months or even years. Hence studies have been performed evaluating 12-weekly therapy. These have confirmed similar palliative outcomes in the 4 vs 12-weekly groups for both breast and prostate cancer patients. However, there remains clinical equipoise about which dosing interval physicians prescribe. The current trial will compare these two schedules of bone-targeting agents (12- vs. 4-weekly) to evaluate quality of life, pain and skeletal events within the Canadian Health Care System. This study will use an "integrated consent model" that involves "oral consent" rather than a written informed consent writing process as the study is comparing standard schedules and not a new administration schedule.

Being tested
Pamidronate, Denosumab, Zoledronate
Medical subject headings
Breast Neoplasms, Prostatic Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PamidronateDrug

    Also called Aredia

    Bone-targeted agent as standard of care

  • DenosumabDrug

    Also called Prolia

    Bone-targeted agent as standard of care

  • ZoledronateDrug

    Also called Zometa

    Bone-targeted agent as standard of care

Study groups in NCT02721433
Study groupRoleWhat they receive
4 weekly bone-targeted agent x 1 yearActive comparatorBone targeting agents as standard of care
Receives: Drug: Pamidronate; Drug: Denosumab; Drug: Zoledronate
12 weekly bone-targeted agent x 1 yearActive comparatorBone targeting agents as standard of care
Receives: Drug: Pamidronate; Drug: Denosumab; Drug: Zoledronate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Health related quality of life scores measured with European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Functional Domain (Physical Subdomain)

    Units on a scale

    Measured: 1 year

Secondary outcomes (7)

  1. Pain will be measured through the EORTC-Quality of Life Questionnaire (QLQ)-BM22 (pain domain)

    Units on a scale

    Measured: 1 year

  2. Health related quality of life scores

    Units on a scale

    Measured: 1 year

  3. Time to development of symptomatic skeletal events (SSEs)

    SSEs defined from the date of randomization until the first date a patient experiences an SSE (an on-study SSE is defined as: use of radiotherapy to relieve skeletal symptoms, new symptomatic pathological bone fractures (vertebral or non-vertebral), spinal cord compression, tumour related orthopedic surgical intervention, hypercalcaemia). Any patient who does not experience a SSE will be censored on the last date the patient can be confirmed as SSE-free. Multiple measurements will be aggregated to arrive at one reported value.

    Measured: 2 year

  4. Total number of and time to subsequent on study SSE - to calculate Skeletal Morbidity Rates

    Multiple measurements will be aggregated to arrive at one reported value.

    Measured: 2 year

  5. For sites where Edmonton Symptom Assessment Scores (ESAS) are performed as standard of care, the ESAS scores will also be collected.

    Units on a scale

    Measured: 2 year

  6. Adverse events/ toxicity profiles will be compared between the two different approaches.

    Measured: 2 year

  7. An economic analysis on Health Services Issues

    We will perform a cost utility analysis alongside this pragmatic randomized controlled trial. The cost effectiveness of 4-week compared to 12-week BTA will be assessed in terms of the incremental cost per quality adjusted life year (QALY) gained from the perspective of health care system. Resource use and health utility will be measured from the trial at the follow up interviews. Health utility values would be estimated from the study questionnaires.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionSep 2019
  4. Study completionApr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
263 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02721433
Sponsor's protocol ID
16-01
Acronym
REaCT-BTA
Status last verified
Dec 2020
First submitted
10 Mar 2016
Last updated
2 Dec 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No: There is no plan to make individual participant data available.

Publications

  • Tu MM, Clemons M, Stober C, Jeong A, Vandermeer L, Mates M, Blanchette P, Joy AA, Aseyev O, Pond G, Fergusson D, Ng TL, Thavorn K. Cost-Effectiveness Analysis of 12-Versus 4-Weekly Administration of Bone-Targeted Agents in Patients with Bone Metastases from Breast and Castration-Resistant Prostate Cancer. Curr Oncol. 2021 May 13;28(3):1847-1856. doi: 10.3390/curroncol28030171.

    PubMed 34068083

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pamidronate, Denosumab and Zoledronate in people with Breast Cancer and Prostate Cancer, run by Ottawa Hospital Research Institute at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health related quality of life scores measured with European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Functional Domain (Physical Subdomain) (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02721433, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2020; AzTrials last refreshed its copy on 6 Nov 2026.

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