RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving letrozole together with erlotinib may kill more tumor cells. PURPOSE: This phase II clinical trial is studying how well giving letrozole together with erlotinib works in treating postmenopausal women with estrogen receptor-positive and/or progesterone receptor-positive locally recurrent or metastatic breast cancer.
OBJECTIVES: Primary * 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 hydrochloride. Secondary * 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 molecules. 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 therapy) 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
OSI-774 150 mg/day
Letrozole 2.5 mg/day
To determine HER2 gene amplification or excess copies of the HER2 gene
to measure the epidermal growth factor receptors (EGFR)
To determine if specific biomarkers exhibit a longer time to tumor progression after treatment with the study drugs
Central Georgia Hematology/Oncology Associates, P.C.
Macon, Georgia, United States
Jennie Stuart Medical Center
Hopkinsville, Kentucky, United States
Purchase Cancer Group
Paducah, Kentucky, United States
Memorial Health Care System
Chattanooga, Tennessee, United States
The Jones Clinic - Germantown
Germantown, Tennessee, United States
Jackson-Madison County Hospital
Jackson, Tennessee, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, United States
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
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
Time frame: at 24 weeks
Median Time to Progression of Target Lesions
Time frame from study entry till discontinuation of treatment due to disease progression. Progression of target lesions is measured by 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, progressive disease (PD) \> 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions.
Time frame: Every 12 weeks from on-study to disease progression
Number of Patients With Anti-tumor Activity: Complete Response (CR) and Partial Response (PR)
Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions and partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions.
Time frame: at 24 weeks
Number of Patients With Worst-grade Toxicities Per Grade
Number of patients with worst-grade toxicities following NCI Common Toxicity Criteria: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, disabling, 5 = death
Time frame: at 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.