Combining Doxycycline With Bone-Targeted Therapy in Patients With Metastatic Breast Cancer (OTT12-05)
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| ClinicalTrials.gov Identifier: NCT01847976 |
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Recruitment Status :
Completed
First Posted : May 7, 2013
Last Update Posted : September 6, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pain | Drug: Doxycycline | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 73 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Doxycycline
100 mg of Doxycycline orally twice a day for 12 weeks.
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Drug: Doxycycline
Participants will be asked to take 100 mg of Doxycycline by mouth twice a day for 12 weeks.
Other Names:
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- 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).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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)
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
| Canada, Ontario | |
| The Ottawa Hospital Cancer Centre | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Principal Investigator: | Mark Clemons, FRCP | The Ottawa Hospital Cancer Centre |
| Responsible Party: | Ottawa Hospital Research Institute |
| ClinicalTrials.gov Identifier: | NCT01847976 |
| Other Study ID Numbers: |
20120543-02H |
| First Posted: | May 7, 2013 Key Record Dates |
| Last Update Posted: | September 6, 2019 |
| Last Verified: | September 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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breast bone pain |
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Doxycycline Anti-Bacterial Agents Anti-Infective Agents |
Antimalarials Antiprotozoal Agents Antiparasitic Agents |

