Status:
COMPLETED
Combining Doxycycline With Bone-Targeted Therapy in Patients With Metastatic Breast Cancer
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Canadian Breast Cancer Foundation
Conditions:
Pain
Eligibility:
FEMALE
19+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to see if women with bone metastases from breast cancer will benefit from the addition of doxycycline to their standard bone-targeted therapy. Participants will be asked t...
Detailed Description
Potential candidates for this trial must have received intravenous bisphosphonate therapy (i.e. pamidronate or zoledronic acid) or subcutaneous denosumab for at least 3 months. Baseline patient charac...
Eligibility Criteria
Inclusion
- Patients with metastatic breast cancer with radiologically confirmed bone metastases.
- On intravenous bone-targeted therapy (bisphosphonate or subcutaneous (SC) denosumab) for at least 3 months.
- ECOG ≤ 2
- Life expectancy \>3 months.
- No changes in the type of systemic chemotherapy, endocrine therapy or biological therapy (i.e. trastuzumab, lapatinib) treatment in the 4 weeks prior to study entry or anticipated changes in the 4 weeks after entering the study. (Markers of bone formation can be affected by a change in systemic therapies).
- Ability to provide informed consent and complete study evaluations.
Exclusion
- Prior hypersensitivity to either IV bisphosphonate therapy or SC denosumab, doxycycline or tetracyclines.
- Patients with myasthenia gravis
- Patients taking hepatic enzymes inducers such as phenytoin, barbiturates and carbamazepine
- Patients with rapidly progressive non-bone metastases for whom delaying a change in systemic anti-cancer treatment in the first 4 weeks of the study could have a detrimental impact on patient outcome.
- Women of child bearing potential who are unwilling to use acceptable methods of contraception while on study.
- Pregnancy or lactation.
- Clotting disorder that would preclude bone marrow aspirate and trephine biopsy. (Patients on Fragmin or Daltaperin are allowed on study)
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2017
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT01847976
Start Date
August 1 2013
End Date
November 1 2017
Last Update
September 6 2019
Active Locations (1)
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1
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6