Conditions: Breast Cancer
Keywords: recurrent breast cancer stage IV breast cancer
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 48
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: erlotinib hydrochloride intervention 2: letrozole intervention 3: fluorescence in situ hybridization intervention 4: immunohistochemistry staining method intervention 5: laboratory biomarker analysis
Intervention descriptions: intervention 1: OSI-774 150 mg/day intervention 2: Letrozole 2.5 mg/day intervention 3: To determine HER2 gene amplification or excess copies of the HER2 gene intervention 4: to measure the epidermal growth factor receptors (EGFR) intervention 5: To determine if specific biomarkers exhibit a longer time to tumor progression after treatment with the study drugs

Protocol document: