Pharmacokinetics and Safety of Epidiferphane and Taxanes in Breast Cancer Patients

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 reg

Trial Details

NCT ID
NCT05074290
Phase
PHASE1 / PHASE2
Sponsor
University of Florida
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Epidiferphane
  • Taxane Chemotherapy
Locations (sample)
  • Gainesville, Florida, United States|29.65163,-82.32483

Key Eligibility 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. Subjec…
  • Must be about to start a new treatment regimen containing either paclitaxel given weekly or docetaxel given every 3 weeks or nab-paclitaxel given w…
  • Paclitaxel weekly at 80-90 mg/m2

For full eligibility, visit ClinicalTrials.gov.

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