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Epidiferphane and Taxanes for Breast Cancer

This study is looking at how a nutritional supplement called Epidiferphane works with standard taxane chemotherapy (like paclitaxel or docetaxel) in people with breast cancer. Taxane chemotherapy can cause side effects like anemia (low red blood cells) and peripheral neuropathy (nerve damage), which sometimes lead to changes in treatment that can make it less effective. Earlier studies in animals suggest Epidiferphane might help reduce these side effects. This study will measure how much Epidiferphane and taxane drugs are in your body (pharmacokinetics) and check for any safety concerns. You may be able to join if you are at least 18 years old and have breast cancer.

Study design
This is an interventional study planning to enroll 74 participants. It will start with a small group to find the right dose of Epidiferphane, then expand to more participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints measure drug levels at 24 hours, but the overall follow-up duration is not specified.

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NCT05074290

Pharmacokinetics and Safety of Epidiferphane and Taxanes in Breast Cancer Patients

Recruiting
PHASE1Ages 18–99InterventionalTreatment
University of Florida
~74 participants
Updated 2026-02-17 on ClinicalTrials.gov
What's tested:EpidiferphaneTaxane Chemotherapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cmax of Epidiferphane's components
Measured over 24 hours
+6 more outcomes measured

Conditions

Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Coy Heldermon · PRINCIPAL_INVESTIGATOR · University of Florida

Who to contact

Priya Gurjar
[email protected]
352-273-6772
Email the study team

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Eligibility criteria

Inclusion

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
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.

Exclusion

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.
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

What this trial measures

  • Cmax of Epidiferphane's components24 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 taxanes24 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 components24 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 taxanes24 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 taxanes4 months
  • Rate of Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade 2 or higher neuropathy4 months
  • Rate of Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade 1 or higher anemia4 months