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

Breast Cancer Clinical Trial

Official title:

A "Window Trial" on Curcumin, the Active Compound in Turmeric, for Invasive Breast Cancer Primary Tumors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03980509
• Other study ID #: 103089
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: January 29, 2020
• Est. completion date: August 31, 2024

Study information

• Verified date: April 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: August 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Curcumin
Curcumin is an extract from turmeric

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of adverse events reported	Safety data will be tabulated by type and grade of adverse event and will use CTCAE v. 4.0	up to 84 days