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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

Recruiting
18 years of age
Both
Phase 4

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Overview

The investigators propose is 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

Eligibility

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study details

Breast Cancer, Castration-resistant Prostate Cancer

NCT04549207

Ottawa Hospital Research Institute

25 January 2024

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