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

Medical University of South Carolina (MUSC)

Status and phase: Completed; Phase 1

Conditions: Breast Cancer

Treatments: Drug: Boswellia

Study type: Interventional

Funder types: Other

Identifiers

NCT03149081

102688

Details and patient eligibility

About

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

Full description

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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

Boswellia

Experimental group

Description:

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.

Treatment:

Drug: Boswellia