A “Window Trial” on Boswellia for Breast Cancer Primary Tumors

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.