OncoMatch/Clinical Trials/NCT05074290
Pharmacokinetics and Safety of Epidiferphane and Taxanes in Breast Cancer Patients
Is NCT05074290 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Epidiferphane and Taxane Chemotherapy for breast cancer.
Treatment: Epidiferphane · Taxane Chemotherapy — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Performance status
ECOG 0–3(Limited self-care)
Lab requirements
Blood counts
hemoglobin < 10 mg/dL, CTCAE v 5.0 grade 3 or higher neutropenia or thrombocytopenia excluded
Kidney function
GFR <50 mL/min excluded
Liver function
ALT or AST >2.5 × ULN excluded; Total bilirubin >1.5 × ULN or >3 × ULN in Gilbert's Syndrome excluded
hemoglobin < 10 mg/dL, CTCAE v 5.0 grade 3 or higher neutropenia or thrombocytopenia; ALT or AST >2.5 × ULN; Total bilirubin >1.5 × ULN or >3 × ULN in Gilbert's Syndrome; GFR <50 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Florida · Gainesville, Florida
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