A Window Trial on Boswellia for Breast Cancer Primary Tumors

Study Overview
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Brief Summary
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The purpose of this study is to determine whether oral administration of Boswellia causes biological changes in primary tumors of breast cancer patients.

Detailed Description
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To determine whether oral administration of Boswellia serrata causes biological changes related to angiogenesis (CD31), apoptosis (DNA fragmentation), and cell proliferation (Ki67) in primary tumors of breast cancer patients.

Official Title
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A Window Trial on Boswellia, an Extract From Frankincense, for Breast Primary Tumors

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Boswellia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed ductal carcinoma in situ (DCIS) or invasive breast cancer (stages I, II, or III) with primary tumor(s) ≥ 1.0 cm on mammogram, ultrasound, MRI, or physical exam 18 years of age or older Subject must understand risks and benefits of the protocol and be able to give informed consent Females of child-bearing potential must agree to use an approved form of birth control and to have a negative pregnancy test result before and throughout the study Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Adequate hematologic and end organ function Ability and capacity to comply with the study and follow-up procedure Subjects must be scheduled for surgery at MUSC no less than 5 days from the planned start of day 1 and no more than 56 days from the planned start of day 1. At least 6 sections of unstained slides should be obtained. If sufficient slides or tissue is unavailable, the patient will be excluded from the trial. Exclusion Criteria: Subjects undergoing neoadjuvant chemotherapy or neoadjuvant endocrine therapy Subjects with end-stage kidney disease and/or grade II liver dysfunction Subject has active or history of deep vein thrombosis (DVT) Subject has a history of coagulopathies or hematological disorders Subjects who are pregnant or are lactating. Subjects already taking drugs known to be 5-lipoxygenase inhibitors (Refer to section 5) Subjects taking drugs that interact with OATP1B3 (an anion transporter), MRP2 (a multidrug resistant protein), and/or P-Glycoprotein (P-Gp) (Refer to section 5.) Subjects taking anti-coagulants or platelet inhibitors (Refer to section 5) Subjects with bowel obstruction Subjects undergoing emergency surgery.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Boswellia<br>Boswellia will be given at 800mg by mouth three times a day, immediately after each meal. Boswellia will be given from the time surgical resection is scheduled until the night before surgical resection. | Drug: Boswellia<br>* Boswellia is an extract from frankincense<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in tumor proliferation rate | Change in tumor proliferation rate will be based on Ki67, CD31 and TUNEL assays in biopsies pre and post treatment with boswellia | up to 56 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events reported | Safety data will be tabulated by type and grade of adverse event and will use CTCAE v. 4.0 | up to 84 days | 
| Changes in tumors analyzed through immunohistochemistry | Additional changes in tumors as a result of boswellia intake will be analyzed through immunohistochemistry on paraffin-embedded tumors. | up to 56 days |