A "Window Trial" on Boswellia for Breast Cancer Primary Tumors

• Status: Recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina

Criteria

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.