Breast CancerPhase 1/2NCT05074290
Pharmacokinetics and Safety of Epidiferphane and Taxanes in Breast Cancer Patients
A Phase 1/2 study testing Epidiferphane and Taxane Chemotherapy in people with Breast Cancer, run by University of Florida at 1 site in United States.
Trial summary
Patients with breast cancer are commonly treated with taxane chemotherapy. Some very common side effects of taxanes, such as anemia and peripheral neuropathy, are often as not well addressed during treatment, resulting in dose reductions, dose delays and early discontinuation (collectively called relative dose… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Epidiferphane and Taxane Chemotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2023to Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be at least 18 years of age
- Subjects on the phase I portion must either be initiating neoadjuvant chemotherapy or have a clinical diagnosis of metastatic breast cancer. Subjects on the phase II portion must have a clinical diagnosis of breast cancer of any stage and histology.
- Must be about to start a new treatment regimen containing either paclitaxel given weekly or docetaxel given every 3 weeks or nab-paclitaxel given weekly or every 3 weeks at UF Health, at one of the following doses:
- Paclitaxel weekly at 80-90 mg/m2
- Nab-paclitaxel weekly at 75-125 mg/m2 or every three weekly at 260 mg/m2
- Docetaxel every three weeks at 75-100 mg/m2
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- An ECOG Performance Status less than or equal to 3 based on treating physician assessment
- Must continue cancer therapy at UF Health for at least the next three months
- Must not have more than one active malignancy at the time of enrollment (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen [as determined by the treating physician and approved by the PI] may be included.
- A functioning digestive tract with no obstruction
- Subjects must be willing to avoid regular consumption of green tea and curcumin supplements for the duration of trial participation.
- Written informed consent obtained from the subject and the ability for the subject to comply with all the study-related procedures.
- Subjects of childbearing potential (SOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study.
- Subjects with partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study.
Who cannot join
- Must not be receiving any other investigational agents
- Subjects of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and following completion of taxane therapy for an additional 6 months for subjects of child bearing potential and 3 months for subjects with partners of child bearing potential.
- Subjects who are pregnant or breastfeeding
- Active systemic infection considered to be opportunistic, life threatening or clinically significant at the time of treatment.
- Psychiatric illness or social situation that would limit compliance with trial requirements.
- Known allergy to turmeric, broccoli, or green tea.
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- Subjects must not be on treatment with strong CYP3A4 inhibitors such as tacrolimus or on verapamil during the trial.
- History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding (e.g. hemoglobin < 10 mg/dL, CTCAE v 5.0 grade 3 or higher neutropenia or thrombocytopenia) giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.
- Prisoners or subjects who are involuntarily incarcerated.
- Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
- Subjects demonstrating an inability to comply with the study and/or follow-up procedures.
- CTCAE v 5.0 grade 2 or higher peripheral sensory or motor neuropathy
- CTCAE v 5.0 grade 1 or higher paresthesia
- Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) >2.5 × the upper limit of normal (ULN)
- Total bilirubin (TBL) >1.5 × ULN or >3 × ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia)
- Glomerular filtration rate (GFR) <50 mL/min
- Red blood cell infusions < 30 days prior to treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32608
Danielle Ogden, 352-733-0488, d.ogden@ufl.edu
Coy Heldermon, MD, PhD
About this study
Patients with breast cancer are commonly treated with taxane chemotherapy. Some very common side effects of taxanes, such as anemia and peripheral neuropathy, are often as not well addressed during treatment, resulting in dose reductions, dose delays and early discontinuation (collectively called relative dose intensity) of these chemotherapy agents in 15-80 % of patients on these drugs. This reduction in relative dose intensity (RDI) results in worse clinical outcomes such as progression free and overall survival. Pre-clinical studies in mouse models subjected to standardized chemotherapy regimens containing paclitaxel or oxaliplatin have shown that the nutritional supplement Epidiferphane reduces both neuropathy and anemia. This study will investigate whether the use of Epidiferphane in patients with breast cancer receiving taxane chemotherapy results in an attenuation of the side effects experienced, as well as an improvement in tumor response rate. The safety and maximum tolerated dose of Epidiferphane in this patient population will also be determined in this study.
- Conditions
- Breast Cancer
- Being tested
- Epidiferphane, Taxane Chemotherapy
- Keywords
- breast cancer, taxanes, Epidiferphane
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpidiferphaneDrug
During the phase I portion of the study, subjects will be assigned to take either two (half target dose) or four (full target dose) Epidiferphane tablets orally three times daily following a 3 + 3 design. Three subjects will be sequentially enrolled at each of the 2 dose levels (beginning with the half target dose) until at least one dose-limiting toxicity (DLT) occurs. Dosing escalation will be stopped if two or more DLTs occur at either dose level. The maximum tolerated dose will be one dose level lower than the dose level at which 2 or more DLTs occur. Dose escalation will occur separately for each taxane regimen (docetaxel or paclitaxel).
All subjects in the phase II portion of the study will receive the maximum tolerated dose determined in the phase I portion of the study for their taxane regimen.
Subjects in both portions of the study will receive treatment with Epidiferphane for a maximum of three months.
Taxane ChemotherapyDrug
All subjects on both phases of the study will be concurrently treated with a taxane regimen containing either paclitaxel given weekly, nab-paclitaxel given weekly or every 3 weeks or docetaxel given every 3 weeks. The choice of taxane regimen will be determined by the treating physician prior to consenting to participate in this trial.
| Study group | Role | What they receive |
|---|---|---|
| Epidiferphane + taxane chemotherapy | Experimental | Not described Receives: Drug: Epidiferphane; Drug: Taxane Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of Epidiferphane's components
The Cmax of each of Epidiferphane's components will be based on blood concentration measured prior to taxane chemotherapy administration, as well as at 1, 2 and 24 hours after taxane chemotherapy administration.
The Cmax of each of Epidiferphane's components will be the blood concentration measured prior to taxane chemotherapy administration, as well as at 1, 2 and 24 hours after taxane chemotherapy administration.
Measured: 24 hours
Cmax of taxanes
The Cmax of the taxane chemotherapy agents given will be based on blood concentrations measured prior to taxane chemotherapy administration, as well as at 1, 2 and 24 hours after taxane chemotherapy administration.
Measured: 24 hours
Concentration at 24 hours (C24 hours) of Epidiferphane's components
The C24 hours of each of Epidiferphane's components will be based on blood concentration measured 24 hours after taxane chemotherapy administration.
Measured: 24 hours
Concentration at 24 hours (C24 hours) of taxanes
The C24 hours of the taxanes given will be based on blood concentration measured 24 hours after taxane chemotherapy administration.
Measured: 24 hours
Maximum tolerated dose of Epidiferphane in patients with breast cancer who are being treated with taxanes
Measured: 4 months
Rate of Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade 2 or higher neuropathy
Measured: 4 months
Rate of Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade 1 or higher anemia
Measured: 4 months
Secondary outcomes (7)
Effect of Epidiferphane on quality of life, as measured by the EORTC QLQ-C30 scale
The EORTC QLQ-C30 measures ability to perform everyday activities and whether the subject has experienced select physical symptoms on a scale of 1-4 (with 1 meaning "Not at all" and 4 meaning "Very much"), as well as overall quality of life and overall healt over the past week on a scale from 1-7 (with 1 meaning "Very Poor" and 7 meaning "Excellent").
Measured: 3 months
Effect of Epidiferphane on quality of life, as measured by the FACT-Taxane scale
The FACT-Taxane measures various aspects of physical, social, emotional, and functional well-being, as well as whether the subject has experienced select physical symptoms over the past 7 days, on a scale of 0-4 (with 0 meaning "Not at all" and 4 meaning "Very much").
Measured: 3 months
Objective response rate
Determine the objective response rate, defined as the percentage of subjects with a complete or partial response, as measured by RECIST 1.1 criteria, or descriptive statistics if RECIST measurements are not possible due to modality of imaging.
Measured: 3 months
Concentration of the neuropathy marker NF-kB, as measured by multiplex cytokine bead analysis or ELISA (enzyme-linked immunosorbent assay)
Measured: 3 months
Concentration of the neuropathy marker VEGFA, as measured by multiplex cytokine bead analysis or ELISA (enzyme-linked immunosorbent assay)
Measured: 3 months
Concentration of the neuropathy marker Nrf2, as measured by multiplex cytokine bead analysis or ELISA (enzyme-linked immunosorbent assay)
Measured: 3 months
Concentration of the neuropathy marker IL18, as measured by multiplex cytokine bead analysis or ELISA (enzyme-linked immunosorbent assay)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start30 Mar 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
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 University of FloridaThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Coy Heldermon, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074290
- Sponsor's protocol ID
- UF-BRE-007
- Status last verified
- Feb 2026
- First submitted
- 29 Sep 2021
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Safety of Epidiferphane and Taxanes in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05074290
- Acronym / sponsor ID
- UF-BRE-007
- Conditions
- Breast Cancer
- Keywords
- breast cancer, taxanes, Epidiferphane
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Oct 2021 (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.
Patients with breast cancer are commonly treated with taxane chemotherapy. Some very common side effects of taxanes, such as anemia and peripheral neuropathy, are often as not well addressed during treatment, resulting in dose reductions, dose delays and early discontinuation (collectively called relative dose intensity) of these chemotherapy agents in 15-80 % of patients on these drugs. This reduction in relative dose intensity (RDI) results in worse clinical outcomes such as progression free and overall survival. Pre-clinical studies in mouse models subjected to standardized chemotherapy regimens containing paclitaxel or oxaliplatin have shown that the nutritional supplement Epidiferphane reduces both neuropathy and anemia. This study will investigate whether the use of Epidiferphane in patients with breast cancer receiving taxane chemotherapy results in an attenuation of the side effects experienced, as well as an improvement in tumor response rate. The safety and maximum tolerated dose of Epidiferphane in this patient population will also be determined in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epidiferphane + taxane chemotherapy | Experimental | Drug: Epidiferphane, Drug: Taxane Chemotherapy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Must be at least 18 years of age
- Subjects on the phase I portion must either be initiating neoadjuvant chemotherapy or have a clinical diagnosis of metastatic breast cancer. Subjects on the phase II portion must have a clinical diagnosis of breast cancer of any stage and histology.
- Must be about to start a new treatment regimen containing either paclitaxel given weekly or docetaxel given every 3 weeks or nab-paclitaxel given weekly or every 3 weeks at UF Health, at one of the following doses:
- An ECOG Performance Status less than or equal to 3 based on treating physician assessment
- Must continue cancer therapy at UF Health for at least the next three months
Key exclusion criteria (17 listed)
- Must not be receiving any other investigational agents
- Subjects of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and following completion of taxane therapy for an additional 6 months for subjects of child bearing potential and 3 months for subjects with partners of child bearing potential.
- Subjects who are pregnant or breastfeeding
- Active systemic infection considered to be opportunistic, life threatening or clinically significant at the time of treatment.
- Psychiatric illness or social situation that would limit compliance with trial requirements.
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 |
|---|---|---|
| EpidiferphaneDuring the phase I portion of the study, subjects will be assigned to take either two (half target dose) or four (full target dose) Epidiferphane tablets orally three times daily following a 3 + 3 design. Three subjects will be sequentially enrolled at each of the 2 dose levels (beginning with the half target dose) until at least one dose-limiting toxicity (DLT) occurs. Dosing escalation will be stopped if two or more DLTs occur at either dose level. The maximum tolerated dose will be one dose level lower than the dose level at which 2 or more DLTs occur. Dose escalation will occur separately for each taxane regimen (docetaxel or paclitaxel). All subjects in the phase II portion of the study will receive the maximum tolerated dose determined in the phase I portion of the study for their taxane regimen. Subjects in both portions of the study will receive treatment with Epidiferphane for a maximum of three months. | Drug | Epidiferphane + taxane chemotherapy |
| Taxane ChemotherapyAll subjects on both phases of the study will be concurrently treated with a taxane regimen containing either paclitaxel given weekly, nab-paclitaxel given weekly or every 3 weeks or docetaxel given every 3 weeks. The choice of taxane regimen will be determined by the treating physician prior to consenting to participate in this trial. | Drug | Epidiferphane + taxane chemotherapy |
Primary outcome
Cmax of Epidiferphane's components
Time frame: 24 hours
The Cmax of each of Epidiferphane's components will be based on blood concentration measured prior to taxane chemotherapy administration, as well as at 1, 2 and 24 hours after taxane chemotherapy administration. The Cmax of each of Epidiferphane's components will be the blood concentration measured prior to taxane chemotherapy administration, as well as at 1, 2 and 24 hours after taxane chemotherapy administration.
Cmax of taxanes
Time frame: 24 hours
The Cmax of the taxane chemotherapy agents given will be based on blood concentrations measured prior to taxane chemotherapy administration, as well as at 1, 2 and 24 hours after taxane chemotherapy administration.
Concentration at 24 hours (C24 hours) of Epidiferphane's components
Time frame: 24 hours
The C24 hours of each of Epidiferphane's components will be based on blood concentration measured 24 hours after taxane chemotherapy administration.
Concentration at 24 hours (C24 hours) of taxanes
Time frame: 24 hours
The C24 hours of the taxanes given will be based on blood concentration measured 24 hours after taxane chemotherapy administration.
Maximum tolerated dose of Epidiferphane in patients with breast cancer who are being treated with taxanes
Time frame: 4 months
Rate of Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade 2 or higher neuropathy
Time frame: 4 months
Rate of Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade 1 or higher anemia
Time frame: 4 months
7 secondary outcomes
Effect of Epidiferphane on quality of life, as measured by the EORTC QLQ-C30 scale
Time frame: 3 months
Effect of Epidiferphane on quality of life, as measured by the FACT-Taxane scale
Time frame: 3 months
Objective response rate
Time frame: 3 months
Concentration of the neuropathy marker NF-kB, as measured by multiplex cytokine bead analysis or ELISA (enzyme-linked immunosorbent assay)
Time frame: 3 months
Concentration of the neuropathy marker VEGFA, as measured by multiplex cytokine bead analysis or ELISA (enzyme-linked immunosorbent assay)
Time frame: 3 months
Concentration of the neuropathy marker Nrf2, as measured by multiplex cytokine bead analysis or ELISA (enzyme-linked immunosorbent assay)
Time frame: 3 months
Concentration of the neuropathy marker IL18, as measured by multiplex cytokine bead analysis or ELISA (enzyme-linked immunosorbent assay)
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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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.
Coy Heldermon principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Epidiferphane and Taxane Chemotherapy in people with Breast Cancer, run by University of Florida 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 14 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 17 Feb 2026. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Priya Gurjar (352-273-6772, PMO@cancer.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of Epidiferphane's components (time frame: 24 hours). The study lists 7 primary outcomes in all. 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 17 Feb 2026.