A "Window Trial" on Curcumin for Invasive Breast Cancer Primary Tumors

Medical University of South Carolina (MUSC)

Status and phase: Active, not recruiting; Phase 1

Conditions: Breast Cancer

Treatments: Drug: Curcumin

Study type: Interventional

Funder types: Other

Identifiers

NCT03980509

103089

Details and patient eligibility

About

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

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Curcumin

Experimental group

Description:

Curcumin will be given at 500mg by mouth twice a day, immediately after each meal. Curcumin will be given from the time surgical resection is scheduled until the night before surgical resection.

Treatment:

Drug: Curcumin