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Sponsors and Collaborators: |
Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00611715 |
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.
Condition | Intervention | Phase |
Breast Cancer |
Drug: erlotinib hydrochloride Drug: letrozole Procedure: fluorescence in situ hybridization Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis |
Phase II |
Genetics Home Reference related topics: | breast cancer |
MedlinePlus related topics: | Breast Cancer Cancer |
ChemIDplus related topics: | Erlotinib Erlotinib hydrochloride Letrozole Progesterone |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of Letrozole Plus OSI-774 (Tarceva) in Post-Menopausal Women With ER and/or PR-Positive Metastatic Breast Cancer |
Estimated Enrollment: | 154 |
Study Start Date: | November 2000 |
Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Previously collected tumor tissue samples are analyzed for EGFR and Ser118 ER (cell signaling) via immunohistochemistry and HER2 gene amplification or excess copies of the HER2 gene via fluorescent in situ hybridization (FISH).
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then yearly thereafter.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Postmenopausal, as defined by 1 of the following:
PRIOR CONCURRENT THERAPY:
No more than 1 prior hormonal therapy for metastatic disease, including any of the following:
United States, Kentucky | |||||
Mitchell Memorial Cancer Center at Owensboro Medical Health System | |||||
Owensboro, Kentucky, United States, 42303 | |||||
Purchase Cancer Group - Paducah | |||||
Paducah, Kentucky, United States, 42002 | |||||
United States, Tennessee | |||||
Baptist Regional Cancer Center at Baptist Hospital of East Tennessee | |||||
Knoxville, Tennessee, United States, 37901 | |||||
Jones Clinic - Germantown | |||||
Germantown, Tennessee, United States, 38138 | |||||
West Tennessee Cancer Center at Jackson-Madison County General Hospital | |||||
Jackson, Tennessee, United States, 38301 | |||||
Vanderbilt-Ingram Cancer Center at Franklin | |||||
Nashville, Tennessee, United States | |||||
Vanderbilt-Ingram Cancer Center | |||||
Nashville, Tennessee, United States, 37232-6838 | |||||
Vanderbilt-Ingram Cancer Center - Cool Springs | |||||
Nashville, Tennessee, United States |
Vanderbilt-Ingram Cancer Center |
National Cancer Institute (NCI) |
Study Chair: | Carlos L. Arteaga, MD | Vanderbilt-Ingram Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000586402, VU-VICC-BRE-0303, VU-VICC-030592, GENENTECH-VU-VICC-BRE-0303, NOVARTIS-VU-VICC-BRE-0303 |
First Received: | February 8, 2008 |
Last Updated: | October 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00611715 |
Health Authority: | United States: Federal Government |
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