Breast Cancer Clinical Trial
A “Window Trial” on Boswellia for Breast Cancer Primary Tumors
The purpose of this study is to determine whether oral administration of Boswellia causes biological changes in primary tumors of breast cancer patients.
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.
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.
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.
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There is 1 Location for this study
Charleston South Carolina, 29425, United States
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