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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    20
  • sponsor
    Medical University of South Carolina
Updated on 5 March 2021
estrogen
primary tumor
invasive breast cancer
mammogram

Summary

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

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.

Details
Condition Breast Cancer, Breast Cancer Diagnosis, breast carcinoma, cancer, breast
Treatment Curcumin
Clinical Study IdentifierNCT03980509
SponsorMedical University of South Carolina
Last Modified on5 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Breast Cancer?
Do you have any of these conditions: Breast Cancer or cancer, breast or Breast Cancer Diagnosis or breast carcinoma?
Do you have any of these conditions: cancer, breast or breast carcinoma or Breast Cancer Diagnosis or Breast Cancer?
Do you have any of these conditions: cancer, breast or Breast Cancer Diagnosis or breast carcinoma or Breast Cancer?
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
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

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
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