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Breast CancerPhase 4NCT04549207

Comparing Continuation or De-escalation of Bone Modifying Agents (BMA) in Patients Treated for Over 2 Years for Bone Metastases From Either Breast or Castration-resistant Prostate Cancer

A Phase 4 study testing Bone modifying agent in people with Breast Cancer and Castration-resistant Prostate Cancer, run by Ottawa Hospital Research Institute at 5 sites in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The investigators propose to perform a pragmatic, multicenter, open-label, randomised clinical trial to demonstrate the efficacy and safety of either continuing or further de-escalating BMA after a minimum of two years of BMA treatment in patients with bone metastases from breast cancer and castration-resistant… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bone modifying agent
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
5 sitesCanada
Study dates
9 Oct 2020to Sep 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 18 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 or breast cancer who are currently receiving BMA
  • Patient has received BMA for 2 or more years counting from the first BMA dose for bone metastases
  • Age 18 years or older
  • Able to provide verbal consent

Who cannot join

  • Definite contraindication for BMA
  • History of, or current evidence of osteonecrosis of the jaw
  • Radiotherapy or surgery to the bone planned within 4 weeks after randomization
  • Current hypercalcemia defined as corrected serum calcium of > 3 mmol/L (from standard bloodwork completed within one month prior to treatment dose)

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Canada5 sites

  • William Osler Health System

    Brampton, Ontario, L6R 3J7

  • London Health Sciences Centre

    London, Ontario, N6A 5W9

  • Southlake Regional Health Centre

    Newmarket, Ontario, L3Y 2P9

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario

  • Thunder Bay Regional Health Sciences Centre

    Thunder Bay, Ontario, P7B 6V4

Other trials in Canada

About this study

Official title: A Randomised Trial Comparing Continuation or De-escalation of Bone Modifying Agents (BMA) in Patients Treated for Over 2 Years for Bone Metastases From Either Breast or Castration-resistant Prostate Cancer (REaCT-Hold BMA)

The investigators propose to perform a pragmatic, multicenter, open-label, randomised clinical trial to demonstrate the efficacy and safety of either continuing or further de-escalating BMA after a minimum of two years of BMA treatment in patients with bone metastases from breast cancer and castration-resistant prostate cancer

Being tested
Bone modifying agent
Keywords
Bone modifying agents, BMA, Breast cancer, Castration-resistant prostate cancer
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Bone modifying agentDrug

    Also called Zoledronate, Denosumab, Pamidronate

    Use of bone modifying agent

Study groups in NCT04549207
Study groupRoleWhat they receive
Standard BMA frequencyActive comparatorContinue standard BMA frequency (every 4 or 12 weeks) as administered previously. If a change in BMA frequency (every 4 weeks to every 12 weeks OR every 12 weeks to every 4 weeks) was prescribed by the physician, this would still be considered on protocol treatment.
Receives: Drug: Bone modifying agent
De-escalate BMA to once every 24 weeksActive comparatorBone modifying agent once every 24 weeks.
Receives: Drug: Bone modifying agent

What is being measured

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

  1. Health related quality of life scores

    Health related quality of life (HR-QoL) scores measured by the European Organisation for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire (QLQ)-C30 physical functioning subscale and the European Organisation for Research and Treatment of Cancer (EORTC)- Quality of Life Questionnaire (QLQ)- for patients with bone metastasis (BM)22 functional interference subscale. The EORTC-QLQ-C30 is an internationally accepted and validated tool in multiple large study cohorts capturing HR-QoL from a multi-dimensional and global perspective in oncology. EORTC-QLQ-BM22 has been validated for use specifically in bone metastases. They were developed in collaboration with patients, healthcare professionals and thorough review of the literature, and therefore important to all stakeholders; the scales are well-defined and easily measured, and HR-QoL is a relevant goal of care in the palliative care setting.

    Measured: 48 weeks after randomization (one year of treatment)

Secondary outcomes (8)

  1. Symptomatic Skeletal Event (SSE)

    Number of patients with one or more SSEs (defined as: use of radiotherapy to relieve skeletal symtoms, new symptomatic pathological bone fractures [vertebral or non-vertebral], spinal cord compression, tumour-related orthopedic surgical intervention, or hypercalcaemia] during trial period) up to 2 years post-randomization.

    Measured: 2 years post-randomization

  2. Time to development of Symptomatic Skeletal Event

    Defined from the date of randomization until the first date of patient experience an SSE. Any patient who does not experience an SSE will be censored on the last follow-up date and the patient can be confirmed as SSE-free (up to 2 years).

    Measured: 2 years post-randomization

  3. Symptomatic Skeletal Event-free survival

    SSE-free survival (composite of time to first SSE and time to death)

    Measured: 2 years post-randomization

  4. Skeletal morbidity

    Skeletal morbidity rate defined as ration of number of SSEs for each subject divided by the subject's time at risk in years.

    Measured: 2 years post-randomization

  5. Quality of life of cancer patients using the EORTC-QLQ-C30

    Assess quality of life of cancer patients using the EORTC-QLQ-C30 (cancer patient specific questionnaire) at each time point, up to and including 48 weeks ("one year of treatment")

    Measured: 48 weeks post-randomization

  6. Quality of life of cancer patients using the EORTC-QLQ-BM22

    Assess quality of life of cancer patients using the EORTC-QLQ-BM22 (patients with bone metastases specific questionnaire) at each time point, up to and including 48 weeks ("one year of treatment")

    Measured: 48 weeks post-randomization

  7. BMA-related toxicity rates

    BMA-related toxicity rates (up to 2 years) based on standard of care blood tests and clinical assessments

    Measured: 2 years post-randomization

  8. Incremental cost-effectiveness rations

    Defined as the difference in cost between two possible interventions, divided by the difference in their Quality Adjusted Life Year (QALY) gained.

    Measured: 2 years post-randomization

Timeline

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

  1. First posted16 Sep 2020
  2. Study start9 Oct 2020
  3. Primary completion17 Apr 2025
  4. Study completionSep 2026 (estimated)

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
Parallel groups
Masking
None (open label)
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04549207
Sponsor's protocol ID
REaCT-Hold BMA
Status last verified
Jul 2026
First submitted
1 Sep 2020
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ng TL, Tu MM, Ibrahim MFK, Basulaiman B, McGee SF, Srikanthan A, Fernandes R, Vandermeer L, Stober C, Sienkiewicz M, Jeong A, Saunders D, Awan AA, Hutton B, Clemons MJ. Long-term impact of bone-modifying agents for the treatment of bone metastases: a systematic review. Support Care Cancer. 2021 Feb;29(2):925-943. doi: 10.1007/s00520-020-05556-0. Epub 2020 Jun 13.

    PubMed 32535678

  • AlZahrani M, Clemons M, Vandermeer L, Sienkiewicz M, Awan AA, Hutton B, Pond GR, Ng TL. Real-world practice patterns and attitudes towards de-escalation of bone-modifying agents in patients with bone metastases from breast and prostate cancer: A physician survey. J Bone Oncol. 2020 Nov 10;26:100339. doi: 10.1016/j.jbo.2020.100339. eCollection 2021 Feb.

    PubMed 33294318

  • Alzahrani M, Clemons M, Sienkiewicz M, Shrem NS, McGee SF, Vandermeer L, Sehdev S, Savard MF, Awan A, Canil C, Hutton B, Pond G, Saunders D, Ng T. Perceptions around bone-modifying agent use in patients with bone metastases from breast and castration resistant prostate cancer: a patient survey. Support Care Cancer. 2021 Nov;29(11):6903-6912. doi: 10.1007/s00520-021-06238-1. Epub 2021 May 22.

    PubMed 34023950

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bone modifying agent in people with Breast Cancer and Castration-resistant Prostate Cancer, run by Ottawa Hospital Research Institute at 5 sites 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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

This study is still under way. Results are not available in the source record yet.

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 (time frame: 48 weeks after randomization (one year of treatment)). 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 NCT04549207, which also lists 3 linked publications.

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 21 Jul 2026.

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Clinical Trial NCT04549207 | AzTrials