Breast Cancer Clinical Trial
Official title:
An Open Label Phase I/II Study of Humanized Human Milk Fat Globule-1 (THEREX) in Patients With Locally Advanced or Metastatic Breast Cancer Following Prior Anthracycline and Taxane Therapy
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver
tumor-killing substances to them without harming normal cells.
PURPOSE: Phase I/II trial to study the effect of monoclonal antibody therapy on the body and
its effectiveness in treating women who have locally advanced or metastatic breast cancer
that was previously treated with combination chemotherapy.
OBJECTIVES:
- Determine the safety and tolerability of monoclonal antibody HuHMFG1 in women with
locally advanced or metastatic breast cancer previously treated with anthracycline and
taxane-based therapy.
- Determine the maximum tolerated dose and appropriate schedule of this drug in these
patients.
- Determine the pharmacokinetic profile of this drug in these patients.
- Determine the tumor response rate, progression-free survival, and median survival of
patients treated with this drug.
- Analyze immunological markers for evaluation of disease status (e.g., in vitro analysis
of antibody-dependent cellular cytotoxicity, natural killer cell activity, complement
depletion, and tumor markers CA 15.3 and CEA) in patients treated with this drug.
OUTLINE: This is a dose-escalation, open-label, nonrandomized, multicenter study.
- Phase I: Patients receive monoclonal antibody HuHMFG1 IV over 1-3 hours once every 3
weeks for doses 1 and 2. All subsequent dose intervals are based on individual
half-life value of the drug. Patients receive at least 6 doses in the absence of
disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of monoclonal antibody HuHMFG1 until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
- Phase II:Patients receive monoclonal antibody HuHMFG1 as above at the MTD. Patients are
followed at 28 days.
PROJECTED ACCRUAL: Approximately 3-40 patients (3-15 patients for phase I and 19-25 patients
for phase II) will be accrued for this study within approximately 12 months.
;
Masking: Open Label, Primary Purpose: Treatment
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