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

Ottawa Hospital Research Institute

Status and phase: Active, not recruiting; Phase 4

Conditions: Breast Cancer; Castration-resistant Prostate Cancer

Treatments: Drug: Bone modifying agent

Study type: Interventional

Funder types: Other

Identifiers

NCT04549207

REaCT-Hold BMA

Details and patient eligibility

About

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

Enrollment: 240 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Standard BMA frequency

Active Comparator group

Description:

Continue 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.

Treatment:

Drug: Bone modifying agent

De-escalate BMA to once every 24 weeks

Active Comparator group

Description:

Bone modifying agent once every 24 weeks.

Treatment:

Drug: Bone modifying agent