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

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)

Summary:

The investigators propose is to perform a pragmatic, multicentre, 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

Trial Description

Primary Outcome:

• Health related quality of life scores

• Symptomatic Skeletal Event (SSE)
• Time to development of Symptomatic Skeletal Event
• Symptomatic Skeletal Event-free survival
• Skeletal morbidity
• Quality of life of cancer patients using the EORTC-QLQ-C30
• Quality of life of cancer patients using the EORTC-QLQ-BM22
• BMA-related toxicity rates
• Incremental cost-effectiveness rations

View this trial on ClinicalTrials.gov