This phase I trial studies how well Boswellia serrata extract works in treating patients with ductal breast carcinoma in situ or stage I-III breast cancer that are undergoing surgery. Boswellia serrata extract is a supplement made from the Boswellia serrata plant, which helps to reduce inflammation in the body, and may change the make up of the tumors of patients who have breast cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT03149081.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To determine whether oral administration of Boswellia serrata extract (Boswellia serrata) causes biological changes related to angiogenesis (CD31), apoptosis (deoxyribonucleic acid [DNA] fragmentation), and cell proliferation (Ki67) in primary tumors of breast cancer patients.
SECONDARY OBJECTIVES:
I. To determine the safety and toxicity of oral Boswellia serrata extract in patients with breast cancer.
II. To explore other potential biomarkers involved in tumor proliferation and tumor microenvironment.
OUTLINE:
Patients receive Boswellia serrata extract orally (PO) three times daily (TID) for up to 56 days or until the day of surgery, whichever comes first, in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1-4 weeks.
Lead OrganizationMedical University of South Carolina
Principal InvestigatorNancy DeMore