Phase I/II Study Of Herceptin Combined With OSI-774 In The First-Line Treatment Of Metastatic Breast Cancer Associated With HER2/Neu Overexpression
- Determine the maximum tolerated dose and recommended phase II dose of erlotinib when
combined with trastuzumab (Herceptin) as first-line therapy in women with metastatic
breast cancer associated with HER2/neu overexpression. (Phase I closed to accrual as of
- Determine the safety profile of this regimen in these patients.
- Determine the rate and duration of objective response in patients treated with this
- Determine the pharmacologic behavior of this regimen in these patients.
- Determine time to disease progression and duration of survival in patients treated with
- Correlate the antitumor activity of this regimen with epidermal growth factor receptor
expression in these patients.
OUTLINE: This is a dose-escalation study of erlotinib. (Phase I closed to accrual as of
Patients receive oral erlotinib once daily beginning on day 2 and trastuzumab (Herceptin) IV
over 30-90 minutes (1-4 hours after erlotinib) once weekly beginning on day 1. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional
patients are treated at the recommended phase II dose.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for the phase I portion (closed
to accrual as of 01/2004) and 27-81 patients will be accrued for the phase II portion of
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The objective response rate as defined as the rate of complete and partial responses determined on two consecutive occasions greater than or equal to 4 weeks a part.
Carolyn Britten, MD
Jonsson Comprehensive Cancer Center
United States: Federal Government
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