Breast CancerPhase 1NCT03092635
AGE Levels in ER+ Metastatic Breast Cancer Patients Receiving Endocrine Therapy
A Phase 1 study testing OPC 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 look at the effects that the study drug (OPC) has on AGE levels in patients with ER+ metastatic breast cancer. 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?
- OPC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2017to 22 Apr 2022
- 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
- Must have ER+ breast cancer
- Metastatic disease; protocol does allow for bone-only disease
- Must be receiving endocrine therapy
- Must have completed at last 2 months of current endocrine therapy prior to registration
- Must have adequate hematologic, renal and hepatic function
- Prior/concurrent radiation therapy is allowed
Show all 12Show fewer
- Prior chemotherapy is allowed, but last dose must have been at least 2 months prior to enrollment
- May have diabetes, but must not be taking metformin
- Must be able to swallow and retain oral medication
- Performance status of 0-2
- Treated stable brain metastases are allowed, as long as patient does not require steroids or anti-seizure medications
- Must be informed of the investigational nature of this study and must have the ability to sign informed consent.
Who cannot join
- Known allergy to grapes or grape seed
- More than two prior endocrine therapy regimens for the treatment of metastatic ER+ breast cancer.
- Concurrent use of restricted agents outlined in section 4.5.
- History of alcohol abuse within 2 years of registration.
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: Pilot Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in ER+, Metastatic Breast Cancer Patients Receiving Endocrine Therapy
The purpose of this study is to look at the effects that the study drug (OPC) has on AGE levels in patients with ER+ metastatic breast cancer.
Read the detailed description
AGEs are a type of metabolite, or substance, found in the food. The AGE content in food is determined by the types of food you eat and also how you prepare your food. The researchers helping conduct this study have found a potential link between AGE levels and cancer. The purpose of this study is to see if certain drug (OPC) has an effect on the AGE levels in your blood and to see if those AGE levels have an effect on your cancer.
- Conditions
- Breast Cancer
- Being tested
- OPC
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPCDrug
OPC is a derivative of grape seed extract
| Study group | Role | What they receive |
|---|---|---|
| OPC | Experimental | During weeks 1- 12, subjects will take one OPC tablet in the morning and in the evening, about 12 hours apart. Receives: Drug: OPC |
What is being measured
The primary outcome is the main question the study is designed to answer.
AGE level reduction
The primary objective is to determine if the test agents are able to reduce AGE levels by at least 30% in th 50% or more of test subjects.
Measured: 85 days
Secondary outcomes (14)
Correlation between AGE level and changes to BMI
Changes in AGE levels and BMI will be described using graphs and other models.
Measured: 85 days
Correlation between AGE level and insulin resistance (HOMA-IR)
Changes in AGE levels and HOMA-IR will be described using graphs and other models.
Measured: 85 days
Correlation between AGE level and A1C
Changes in AGE levels and A1C will be described using graphs and other models.
Measured: 85 days
Correlation between AGE level and lipids
Changes in AGE levels and lipids will be described using graphs and other models.
Measured: 85 days
Correlation between AGE level and diet
Changes in AGE levels and diet will be described using graphs and other models. Diet will be assessed by using the NIH "Eating at America's Table Study Quick Food Scan" and the NCI "Quick Food Scan"
Measured: 85 days
Correlation between AGE level and quality of life
Measured by FACT-B quality of life questionnaire
Measured: 85 days
Correlation between AGE level and plasma IL6
Changes in AGE levels and IL6 will be described using graphs and other models.
Measured: 85 days
Correlation between AGE level and leptin
Changes in AGE levels and leptin will be described using graphs and other models.
Measured: 85 days
Correlation between AGE level and c-reactive protein (CRP)
Changes in AGE levels and CRP will be described using graphs and other models.
Measured: 85 days
Correlation between AGE level and malondialdehyde (MDA)
Changes in AGE levels and MDA will be described using graphs and other models.
Measured: 85 days
Correlation between AGE level and oxLDLs (low density lipoprotein)
Changes in AGE levels and oxLDLs will be described using graphs and other models.
Measured: 85 days
Correlation between AGE level and sRAGE (soluble receptor for AGE)
Changes in AGE levels and sRAGE will be described using graphs and other models.
Measured: 85 days
Frequency of adverse events as assessed by CTCAE v. 4
Toxicities will be tabulated by type, grade and the visit at which they occurred.
Measured: 85 days
Tumor response to treatment as assessed by RECIST 1.1 or MD Anderson criteria
The anti-tumor response will be measured by comparing baseline and post-treatment imaging using RECIST 1.1 or MD Anderson criteria for bone only disease.
Measured: 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start6 Jun 2017
- Primary completion10 Nov 2021
- Study completion22 Apr 2022
Why it stopped: Original principal investigator departed institution and concluded the study upon departure.
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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Lilly, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03092635
- Sponsor's protocol ID
- 102560
- Status last verified
- Jan 2025
- First submitted
- 22 Mar 2017
- Last updated
- 6 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 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in ER+, Metastatic Breast Cancer Patients Receiving Endocrine Therapy
- ClinicalTrials.gov ID
- NCT03092635
- Acronym / sponsor ID
- 102560
- Conditions
- Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Original principal investigator departed institution and concluded the study upon departure.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 10 Nov 2021 (actual)
- Study completion
- 22 Apr 2022 (actual)
- First posted
- 28 Mar 2017 (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 look at the effects that the study drug (OPC) has on AGE levels in patients with ER+ metastatic breast cancer.
Detailed description
AGEs are a type of metabolite, or substance, found in the food. The AGE content in food is determined by the types of food you eat and also how you prepare your food. The researchers helping conduct this study have found a potential link between AGE levels and cancer. The purpose of this study is to see if certain drug (OPC) has an effect on the AGE levels in your blood and to see if those AGE levels have an effect on your cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OPC | Experimental | Drug: OPCDuring weeks 1- 12, subjects will take one OPC tablet in the morning and in the evening, about 12 hours apart. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Must have ER+ breast cancer
- Metastatic disease; protocol does allow for bone-only disease
- Must be receiving endocrine therapy
- Must have completed at last 2 months of current endocrine therapy prior to registration
- Must have adequate hematologic, renal and hepatic function
Key exclusion criteria (4 listed)
- Known allergy to grapes or grape seed
- More than two prior endocrine therapy regimens for the treatment of metastatic ER+ breast cancer.
- Concurrent use of restricted agents outlined in section 4.5.
- History of alcohol abuse within 2 years of registration.
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 |
|---|---|---|
| OPCOPC is a derivative of grape seed extract | Drug | OPC |
Primary outcome
AGE level reduction
Time frame: 85 days
The primary objective is to determine if the test agents are able to reduce AGE levels by at least 30% in th 50% or more of test subjects.
14 secondary outcomes
Correlation between AGE level and changes to BMI
Time frame: 85 days
Correlation between AGE level and insulin resistance (HOMA-IR)
Time frame: 85 days
Correlation between AGE level and A1C
Time frame: 85 days
Correlation between AGE level and lipids
Time frame: 85 days
Correlation between AGE level and diet
Time frame: 85 days
Correlation between AGE level and quality of life
Time frame: 85 days
Correlation between AGE level and plasma IL6
Time frame: 85 days
Correlation between AGE level and leptin
Time frame: 85 days
Correlation between AGE level and c-reactive protein (CRP)
Time frame: 85 days
Correlation between AGE level and malondialdehyde (MDA)
Time frame: 85 days
Correlation between AGE level and oxLDLs (low density lipoprotein)
Time frame: 85 days
Correlation between AGE level and sRAGE (soluble receptor for AGE)
Time frame: 85 days
Frequency of adverse events as assessed by CTCAE v. 4
Time frame: 85 days
Tumor response to treatment as assessed by RECIST 1.1 or MD Anderson criteria
Time frame: 85 days
Results and safety
The study was stopped early (reason given: Original principal investigator departed institution and concluded the study upon departure.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Michael Lilly, MD 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 OPC 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 12 inclusion and 4 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: stopped early, as of the sponsor's last update on 6 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 was stopped early (reason given: Original principal investigator departed institution and concluded the study upon departure.). Results are not available in the source record.
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?
AGE level reduction (time frame: 85 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 6 Jan 2025.