Curcumin for the Treatment of Stage I-III Invasive Breast Cancer in Patients Undergoing Surgery

Inclusion Criteria

• Histologically confirmed invasive breast cancer (stages I, II, or III) with primary tumor(s) >= 1.0 cm on mammogram, ultrasound, magnetic resonance imaging (MRI), or physical exam. All estrogen receptor (ER), progesterone receptor (PR), and Her2 neu receptor types are eligible
• 18 years of age or older
• Subject must understand risks and benefits of the protocol and be able to give informed consent
• Women of childbearing potential (WOCBP) must agree to use an approved form of birth control for the duration of the study and 2 weeks following the last dose, and to have a negative pregnancy test result within 21 days of 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, intra-vaginal, 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 (obtained within 21 days prior to registration)
• Platelet count >= 100 x 10^9/L (obtained within 21 days prior to registration)
• Hemoglobin >= 9 g/dL (obtained within 21 days prior to registration)
• Albumin >= 2.5 g/dL (obtained within 21 days prior to registration)
• Bilirubin =< 1.5 x the upper limit of normal (ULN) (obtained within 21 days prior to registration)
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =< 3 x ULN (obtained within 21 days prior to registration)
• Alkaline phosphatase =< 3 x ULN (obtained within 21 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 (obtained within 21 days prior to registration) * The Modification of Diet in Renal Disease (Levey et al. 2006) and the Chronic Kidney Disease Epidemiology Collaboration (Levey et al. 2009) formulas for estimation of glomerular filtration rate are also acceptable
• 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
• 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
• Subjects who are pregnant or are lactating
• Subjects with bile duct obstruction, gallstones, predisposition to kidney stones, or gastrointestinal disorders such as stomach ulcers and hyperacidity disorders such as uncontrolled gastroesophageal reflux disease (GERD)
• Subjects taking anti-coagulants or platelet inhibitors
• Subjects taking drugs metabolized by CYP3A4, CYP1A2, and CYP2A6 enzymes
• Subjects taking drugs that interact with P-glycoprotein (P-gp)
• Subjects taking any of the medications listed under other herb-drug interactions according to the Memorial Sloan Kettering Cancer Center