NCT00611715

Ph II Letrozole + OSI-774 (Tarceva) in Post-menopausal, w/ ER and/or PR-positive Met Breast Cancer.

A Phase II Trial of Letrozole Plus OSI-774 (Tarceva) in Post-menopausal Women With ER and/or PR-Positive Metastatic Breast Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	erlotinib hydrochloride	OSI-774 150 mg/day
DRUG	letrozole	Letrozole 2.5 mg/day
GENETIC	fluorescence in situ hybridization	To determine HER2 gene amplification or excess copies of the HER2 gene
OTHER	immunohistochemistry staining method	to measure the epidermal growth factor receptors (EGFR)
OTHER	laboratory biomarker analysis	To determine if specific biomarkers exhibit a longer time to tumor progression after treatment with the study drugs

Timeline

• Start date: 2003-11-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2008-02-11
• Last updated: 2012-08-09
• Results posted: 2012-07-13

Locations

9 sites across 1 country: United States