A Phase II Trial of Letrozole Plus OSI-774 (Tarceva) in Post-menopausal Women With ER and/or PR-Positive Metastatic Breast Cancer
- To determine the rate of clinical benefit (complete response [CR], partial response
[PR], and stable disease [SD] in patients with hormone-dependent locally recurrent or
metastatic breast cancer treated with letrozole in combination with erlotinib
- To determine the time to progression (TTP) in patients treated with this regimen.
- To evaluate the anti-tumor activity, as determined by CR and PR rates, of this regimen
in these patients.
- To evaluate the safety of this regimen in these patients.
- To determine if tumors that are positive for epidermal growth factor receptor (EGFR) or
Ser118 ER, or that overexpress human epidermal receptor (HER2) exhibit a longer TTP
from the combination compared to tumors that do not express or overexpress these
OUTLINE: This is a multicenter study. Patients are stratified according to prior hormone
therapy (hormone-therapy naive/first-line therapy vs prior hormonal therapy with either
tamoxifen or an aromatase inhibitor in the adjuvant or metastatic setting/second-line
Patients receive oral letrozole and oral erlotinib hydrochloride once daily in the absence
of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years, every
6 months for 3 years, and then yearly thereafter.
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients With Pathological Complete Response.
Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions
at 24 weeks
Ingrid Mayer, MD
Vanderbilt-Ingram Cancer Center
United States: Food and Drug Administration
VICC BRE 0303
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|
|Memorial Health Care System||Chattanooga, Tennessee 37404|
|Jackson-Madison County Hospital||Jackson, Tennessee 38301|
|Tennessee Cancer Specialists||Knoxville, Tennessee 37920|
|Vanderbilt-Ingram Cancer Center - Cool Springs||Nashville, Tennessee 37064|
|Jennie Stuart Medical Center||Hopkinsville, Kentucky 42240|
|Central Georgia Hematology/Oncology Associates, P.C.||Macon, Georgia 31201|
|Purchase Cancer Group||Paducah, Kentucky 42002|
|The Jones Clinic - Germantown||Germantown, Tennessee 38138|