Breast CancerPhase 1NCT03980509
A "Window Trial" on Curcumin for Invasive Breast Cancer Primary Tumors
A Phase 1 study testing Curcumin in people with Breast Cancer, run by Medical University of South Carolina at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Curcumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2020to 24 Mar 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 17Show fewer
- 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
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: A "Window Trial" on Curcumin, the Active Compound in Turmeric, for Invasive Breast Cancer Primary Tumors
The purpose of this study is to determine whether oral administration of curcumin causes biological changes in primary tumors of breast cancer patients.
Read the detailed 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.
- Conditions
- Breast Cancer
- Being tested
- Curcumin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDrug
Curcumin is an extract from turmeric
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Curcumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 56 days
Secondary outcomes (1)
Number of adverse events reported
Safety data will be tabulated by type and grade of adverse event and will use CTCAE v. 4.0
Measured: up to 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start29 Jan 2020
- Primary completion24 Mar 2022
- Study completion24 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy DeMore, MD, FACS, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980509
- Sponsor's protocol ID
- 103089
- Status last verified
- Jan 2025
- First submitted
- 6 Jun 2019
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A "Window Trial" on Curcumin, the Active Compound in Turmeric, for Invasive Breast Cancer Primary Tumors
- ClinicalTrials.gov ID
- NCT03980509
- Acronym / sponsor ID
- 103089
- Conditions
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 29 Jan 2020 (actual)
- Primary completion
- 24 Mar 2022 (actual)
- Study completion
- 24 Mar 2023 (actual)
- First posted
- 10 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether oral administration of curcumin causes biological changes in primary tumors of breast cancer patients.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Curcumin | Experimental | Drug: CurcuminCurcumin 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CurcuminCurcumin is an extract from turmeric | Drug | Curcumin |
Primary outcome
Change in tumor proliferation rate
Time frame: Up to 56 days
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
1 secondary outcome
Number of adverse events reported
Time frame: up to 84 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy DeMore, MD, FACS principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Curcumin in people with Breast Cancer, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in tumor proliferation rate (time frame: Up to 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.