Boswellia Serrata Extract in Treating Patients with Ductal Breast Carcinoma In Situ or Stage I-III Breast Cancer That Are Undergoing Surgery
- Histologically confirmed ductal carcinoma in situ (DCIS) or invasive breast cancer (stages I, II, or III) with primary tumor(s) >= 5 mm on mammogram, ultrasound, magnetic resonance imaging (MRI), or physical exam
- Subject must understand risks and benefits of the protocol and be able to give informed consent
- Women of child-bearing potential (WOCBP) must agree to use an approved form of birth control and to have a negative pregnancy test result before registration; WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 consecutive months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes; approved forms of birth control: * Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal) * Progestogen only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable) * Intrauterine device, intrauterine hormone-releasing system * Bilateral tubal occlusion/ligation * Vasectomized partner * Barrier contraception * Sexual abstinence
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (within 14 days prior to registration)
- Platelet count >= 100 x 10^9/L (within 14 days prior to registration)
- Hemoglobin >= 9 g/dL (within 14 days prior to registration)
- Albumin >= 2.5 g/dL (within 14 days prior to registration)
- Bilirubin =< 1.5 x the upper limit of normal (ULN) (within 14 days prior to registration)
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), =< 3 x ULN (within 14 days prior to registration)
- Serum creatinine =< 1.5 x ULN or creatinine clearance (CrCl) >= 40 mL/min on the basis of measured CrCl from a 24-hour urine collection or Cockcroft-Gault glomerular filtration rate estimation (within 14 days prior to registration)
- Ability and capacity to comply with the study and follow-up procedures
- Subjects must be scheduled for surgery at Medical University of South Carolina (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
- For breast cancer patients, 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
- Subjects taking drugs that interact with OATP1B3 (an anion transporter), MRP2 (a multidrug resistant protein), and/or P-glycoprotein (P-Gp)
- Subjects taking anti-coagulants or platelet inhibitors
- Subjects with bowel obstruction
- Subjects undergoing emergency surgery
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.
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.
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.
Trial Phase Phase I
Trial Type Treatment
Medical University of South Carolina
- Primary ID 10801/102688
- Secondary IDs NCI-2017-01671, Pro00067127
- Clinicaltrials.gov ID NCT03149081