Ph II Letrozole + OSI-774 (Tarceva) in Post-menopausal, w/ ER and/or PR-positive Met Breast Cancer.
NCT ID: NCT00611715
Last Updated: 2012-08-09
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
48 participants
INTERVENTIONAL
2003-11-30
2008-12-31
Brief Summary
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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
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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
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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First line/hormone-therapy naive
erlotinib hydrochloride
OSI-774 150 mg/day
letrozole
Letrozole 2.5 mg/day
fluorescence in situ hybridization
To determine HER2 gene amplification or excess copies of the HER2 gene
immunohistochemistry staining method
to measure the epidermal growth factor receptors (EGFR)
laboratory biomarker analysis
To determine if specific biomarkers exhibit a longer time to tumor progression after treatment with the study drugs
Second-line/prev hormone-therapy tx
erlotinib hydrochloride
OSI-774 150 mg/day
letrozole
Letrozole 2.5 mg/day
fluorescence in situ hybridization
To determine HER2 gene amplification or excess copies of the HER2 gene
immunohistochemistry staining method
to measure the epidermal growth factor receptors (EGFR)
laboratory biomarker analysis
To determine if specific biomarkers exhibit a longer time to tumor progression after treatment with the study drugs
Interventions
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erlotinib hydrochloride
OSI-774 150 mg/day
letrozole
Letrozole 2.5 mg/day
fluorescence in situ hybridization
To determine HER2 gene amplification or excess copies of the HER2 gene
immunohistochemistry staining method
to measure the epidermal growth factor receptors (EGFR)
laboratory biomarker analysis
To determine if specific biomarkers exhibit a longer time to tumor progression after treatment with the study drugs
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with available paraffin tissue blocks from either the primary or the metastatic site must submit tissue blocks for retrospective EGFR and HER2 analysis. If tissue blocks cannot be submitted, 20 unstained slides from each paraffin block must be submitted.
* All patients must be post-menopausal females as defined by one of the following:
* Prior bilateral oophorectomy
* Prior bilateral ovarian irradiation
* No menstrual period for 12 months or longer
* If age 55 years or less and \< 12 months from last menstrual period, patient must have a serum estradiol \< or equal to 30 and an FSH level \> 40.
* Patients must not have had more than 1 prior chemotherapy regimen for metastatic disease and have fully recovered from any grade 2-4 toxicities related to chemotherapy. No concurrent chemotherapy is allowed while on protocol therapy.
* Patients may have had 1 prior hormonal therapy for metastatic disease. This includes: tamoxifen, fulvestrant, anastrozole, exemestane, aminoglutethimide, megace, and letrozole. Patients may have received tamoxifen or aromatase inhibitors in the adjuvant setting.
* Patients must not have had prior therapy with EGF receptor inhibitors.
* Previous but not concomitant therapy with trastuzumab (Herceptin) is allowed. Patients must not have received Herceptin within 4 weeks of initiation of protocol therapy.
* Patients must have an ECOG performance status of 0, 1, or 2.
* Patients must have adequate hematologic, hepatic, and renal function as defined by the following within 2 weeks of initiation of therapy:
* Absolute neutrophils \> or equal to 1,500/mm3 and platelets \> or equal to 100,000/mm3.
* Bilirubin \< than or equal to 1.5 upper limit of normal.
* SGOT and SGPT \< or equal to 2.5 upper limit of normal.
* Creatinine \< or equal to 1.5 upper limit of normal.
* INR, PTT and PT in the normal range.
* Must be 18 years of age or older.
* Patients must not have a history of central nervous system metastases or unevaluated CNS symptoms suggestive of possible brain metastases.
* Patients may receive concurrent radiation therapy to painful bone metastases or areas of impending bone fracture as long as radiation therapy is initiated prior to study entry and sites of evaluable disease outside the radiation port(s) are available for follow-up. Patients who have received prior radiotherapy must have recovered from toxicity induced by this treatment.
* Patients \< 55 years of age must not have received Luteinizing hormone releasing hormone (LHRH) antagonists within 3 months prior to protocol therapy.
* Patients must not suffer from medical or psychiatric conditions that would interfere with ability to provide informed consent, communicate side effects, or comply with protocol requirements including maintenance of a compliance/pill diary.
* Patients must be disease-free of prior invasive cancers for \> 5 years with the exception of basal or squamous cancer of the skin or cervical carcinoma in situ.
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Ingrid Mayer, MD
Assistant Professor of Medicine; Clinical Director, Breast Cancer Program; Medical Oncologist
Principal Investigators
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Ingrid Mayer, MD
Role: STUDY_CHAIR
Vanderbilt-Ingram Cancer Center
Locations
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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
Countries
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Other Identifiers
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VU-VICC-BRE-0303
Identifier Type: -
Identifier Source: secondary_id
VU-VICC-030592
Identifier Type: -
Identifier Source: secondary_id
GENENTECH-VU-VICC-BRE-0303
Identifier Type: -
Identifier Source: secondary_id
NOVARTIS-VU-VICC-BRE-0303
Identifier Type: -
Identifier Source: secondary_id
VICC BRE 0303
Identifier Type: -
Identifier Source: org_study_id
NCT00179296
Identifier Type: -
Identifier Source: nct_alias