The purpose of this study is to determine if BMS-690514 + letrozole will be more effective than lapatinib + letrozole in patients who have metastatic hormone receptor positive breast cancer after developing progressive disease immediately following adjuvant antiendocrine therapy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Tablets, Oral, 200 mg, once daily, \~ 12 months depending on response
Tablets, Oral, 1500 mg, once daily, \~ 12 months depending on response
Tablets, Oral, 2.5 mg, once daily, \~ 12 months depending on response
Texas Oncology-Abilene
Abilene, Texas, United States
Texas Oncology-Beaumont
Beaumont, Texas, United States
Us Oncology Central Pharmacy
Fort Worth, Texas, United States
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, United States
Clinical Benefit Rate defined as percentage of subjects with a complete response, partial response, or stable disease for at least 6 months
Time frame: Every 8 weeks according to CT scan
Progression Free Survival: defined as time to disease progression
Time frame: Every 8 weeks
Objective Response Rate: defined as percentage of subjects with 'complete response' or 'partial response'
Time frame: Every 8 weeks
Frequency and severity of adverse events in all subjects
Time frame: Every 4 weeks
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Local Institution
La Rioja, La Rioja Province, Argentina
Local Institution
Rosario, Santa Fe Province, Argentina
Local Institution
Colima, Colima, Mexico
Local Institution
Lima, Lima Province, Peru