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Pharmacokinetics and Safety of Epidiferphane and Taxanes in Breast Cancer Patients | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

Pharmacokinetics and Safety of Epidiferphane and Taxanes in Breast Cancer Patients

NCT05074290•University of Florida

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 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.

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
+4 more criteria

Exclusion Criteria

•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.
+7 more criteria

Locations (1)

University of Florida

Gainesville, Florida, United States

Key Dates

Start Date

March 30, 2023

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2026

Last Updated

February 17, 2026

Enrollment

ESTIMATED participants

Conditions

Breast Cancer

Interventions

Epidiferphane

DRUG

Taxane Chemotherapy

DRUG

Contacts

Priya Gurjar

CONTACT

352-273-6772 PMO@cancer.ufl.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pharmacokinetics and Safety of Epidiferphane and Taxanes in Breast Cancer Patients

Inclusion Criteria

Exclusion Criteria

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