A "Window Trial" on Curcumin for Invasive Breast Cancer Primary Tumors (NCT03980509) | Clinical Trial Compass
CompletedPhase 1
A "Window Trial" on Curcumin for Invasive Breast Cancer Primary Tumors
United States22 participantsStarted 2020-01-29
Plain-language summary
The purpose of this study is to determine whether oral administration of curcumin causes biological changes in primary tumors of breast cancer patients.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
. 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
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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(39), or gastrointestinal disorders such as stomach ulcers and hyperacidity disorders(40)
. 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 in section 5.