Clinical trial NCT04549207: 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Breast Cancer
Castration-resistant Prostate Cancer
Keywords: Bone modifying agents
BMA
Breast cancer
Castration-resistant prostate cancer
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 criteria: 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)

Primary outcomes:
measure: Health related quality of life scores
timeFrame: 48 weeks after randomization (one year of treatment)
Secondary outcomes:
measure: Symptomatic Skeletal Event (SSE)
timeFrame: 2 years post-randomization
measure: Time to development of Symptomatic Skeletal Event
timeFrame: 2 years post-randomization
measure: Symptomatic Skeletal Event-free survival
timeFrame: 2 years post-randomization
measure: Skeletal morbidity
timeFrame: 2 years post-randomization
measure: Quality of life of cancer patients using the EORTC-QLQ-C30
timeFrame: 48 weeks post-randomization
measure: Quality of life of cancer patients using the EORTC-QLQ-BM22
timeFrame: 48 weeks post-randomization
measure: BMA-related toxicity rates
timeFrame: 2 years post-randomization
measure: Incremental cost-effectiveness rations
timeFrame: 2 years post-randomization
Other outcomes:
measure: Frequency of subsequent de-escalation or discontinuation of BMAs
timeFrame: 2 years post-randomization
measure: Frequency of restarting standard dosing BMA
timeFrame: 2 years post-randomization
measure: Overall survival
timeFrame: 2 years post-randomization
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Terry Ng, MD
role: PRINCIPAL_INVESTIGATOR
References: