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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
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Volunteers
Inclusion criteria
Histologically confirmed 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
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:
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 procedures
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
Primary purpose
Allocation
Interventional model
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22 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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