Clinical trial NCT03980509: A "Window Trial" on Curcumin for Invasive Breast Cancer Primary Tumors
Official title: A "Window Trial" on Curcumin, the Active Compound in Turmeric, for Invasive Breast Cancer Primary Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2019-06-10
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: The purpose of this study is to determine whether oral administration of Curcuma longa extract causes biological changes related to apoptosis (DNA fragmentation) and cell proliferation (Ki67) in primary tumors of breast cancer patients.

Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed invasive breast cancer (stages I, II, or III) with primary tumor(s) ≥ 1.0 cm on mammogram, ultrasound, MRI, or physical exam
2. 18 years of age or older
3. Subject must understand risks and benefits of the protocol and be able to give informed consent
4. Women of childbearing potential (WOCBP) must agree to use an approved form of birth control and to have a negative pregnancy test result within 14 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
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6. Adequate hematologic and end organ function
7. Ability and capacity to comply with the study and follow-up procedures
8. 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
9. 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:

1. Subjects undergoing neoadjuvant chemotherapy or neoadjuvant endocrine therapy
2. Subjects with end-stage kidney disease and/or grade II liver dysfunction
3. Subjects who are pregnant or are lactating.
4. Subjects with bile duct obstruction, gallstones, predisposition to kidney stones(39), or gastrointestinal disorders such as stomach ulcers and hyperacidity disorders(40)
5. Subjects taking anti-coagulants or platelet inhibitors
6. Subjects taking drugs metabolized by CYP3A4, CYP1A2, and CYP2A6 enzymes
7. Subjects taking drugs that interact with P-glycoprotein (P-gp)
8. Subjects taking any of the medications listed under Other Herb-Drug interactions according to the Memorial Sloan Kettering Cancer Center in section 5.

Primary outcomes:
measure: Change in tumor proliferation rate
timeFrame: Up to 56 days
Secondary outcomes:
measure: Number of adverse events reported
timeFrame: up to 84 days
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Nancy DeMore, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: