Combining Doxycycline With Bone-Targeted Therapy in Patients With Metastatic Breast Cancer

NCT01847976 | Completed Phase 2 DMC

• 1 other identifier: 20120543-02H
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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 to take 100 mg of Doxycycline orally twice a day for 12 weeks. Blood and tissue collection will further define the mechanism of the benefits if there are any.

Conditions

Pain

Keywords

breast; bone pain

Outcome Measures

Primary Outcomes (1)

• palliative benefit

  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.

  Weeks 4, 8 and 12 from starting study treatment

Secondary Outcomes (1)

• changes to bone formation markers

  Weeks 4, 8 and 12 from starting study treatment

Other Outcomes (1)

• changes in biomarkers

  Weeks 4, 8 and 12 from the start of study treatment

Study Arms (1)

Doxycycline

EXPERIMENTAL

100 mg of Doxycycline orally twice a day for 12 weeks.

Drug: Doxycycline

Interventions

Doxycycline DRUG

Participants will be asked to take 100 mg of Doxycycline by mouth twice a day for 12 weeks.

Also known as: Doryx®, Monodox®, Oracea®, Periostat®, Vibramycin®

Doxycycline

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Breast Cancer Foundation: collaborator

Study Sites (1)

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

MeSH Terms

Conditions

Pain

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Mark Clemons, FRCP

  The Ottawa Hospital Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2013
• First Posted: May 7, 2013
• Study Start: August 1, 2013
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: September 6, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)