Combining Doxycycline With Bone-Targeted Therapy in Patients With Metastatic Breast Cancer (OTT12-05)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01847976|
Recruitment Status : Completed
First Posted : May 7, 2013
Last Update Posted : September 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Doxycycline||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||73 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Trial Exploring the Clinical and Correlative Effects of Combining Doxycycline With Bone-Targeted Therapy in Patients With Metastatic Breast Cancer|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||November 2017|
|Actual Study Completion Date :||November 2017|
100 mg of Doxycycline orally twice a day for 12 weeks.
Participants will be asked to take 100 mg of Doxycycline by mouth twice a day for 12 weeks.
- palliative benefit [ Time Frame: Weeks 4, 8 and 12 from starting study treatment ]The primary objective of this prospective study is to assess the palliative benefit (reflected through changes in validated pain scores and the bone resorption marker serum C-telopeptide) of adding doxycycline 100mg PO BID daily for 3 months to standard bone-targeted (i.e. intravenous bisphosphonate or subcutaneous denosumab) therapy in women with breast cancer and bone metastases.
- changes to bone formation markers [ Time Frame: Weeks 4, 8 and 12 from starting study treatment ]Assess the effect of adding doxycycline for 3 months to standard bone-targeted (i.e. intravenous bisphosphonate or subcutaneous denosumab) therapy on the bone formation markers P1NP and Bone Specific Alkaline Phosphatase.
- changes in biomarkers [ Time Frame: Weeks 4, 8 and 12 from the start of study treatment ]To determine whether levels of FAK, MMPs or TIMPs correlate with palliative benefit, bone turnover, or symptom response in patients treated with doxycycline in combination with bone-targeted (i.e. intravenous bisphosphonate or subcutaneous denosumab) as compared to bone-targeted agent alone. This will be determined following a comparison of levels in baseline specimens (when patients are on bone-targeted agent alone) with end of study specimens (when patients are receiving both doxycycline and bone-targeted agents).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01847976
|The Ottawa Hospital Cancer Centre|
|Ottawa, Ontario, Canada, K1H 8L6|
|Principal Investigator:||Mark Clemons, FRCP||The Ottawa Hospital Cancer Centre|