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

NCT03980509 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 103089
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Change in tumor proliferation rate

  Change in tumor proliferation rate will be based on apoptosis (DNA fragmentation) and cell proliferation (Ki67) assays in biopsies pre and post treatment with curcumin

  Up to 56 days

Secondary Outcomes (1)

• Number of adverse events reported

  up to 84 days

Study Arms (1)

Curcumin

EXPERIMENTAL

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.

Drug: Curcumin

Interventions

Curcumin DRUG

Curcumin is an extract from turmeric

Curcumin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed invasive breast cancer (stages I, II, or III) with primary tumor(s) ≥ 1.0 cm on mammogram, ultrasound, MRI, or physical exam
• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Nancy DeMore, MD, FACS

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 10, 2019
• Study Start: January 29, 2020
• Primary Completion: March 24, 2022
• Study Completion: March 24, 2023
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)