RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving fulvestrant together with trastuzumab is more effective than giving fulvestrant or trastuzumab alone in treating breast cancer. PURPOSE: This randomized phase II trial is studying how well fulvestrant and/or trastuzumab works as first-line therapy in treating postmenopausal women with stage IV breast cancer.
OBJECTIVES: Primary * Compare the overall objective response rate in postmenopausal women with estrogen receptor (ER)- and/or progesterone receptor (PR)-positive, HER2/neu-overexpressing stage IV breast cancer treated with first-line therapy comprising fulvestrant and/or trastuzumab (Herceptin®). Secondary * Compare the duration of response in patients treated with these regimens. * Compare overall survival of patients treated with these regimens. * Compare the antitumor activity of these regimens, in terms of time to disease progression, in these patients. * Compare the clinical benefit of these regimens in these patients. * Determine the safety and toxicity of these regimens in these patients. * Correlate HER2/neu expression and ER and/or PR expression with response in patients treated with these regimens. OUTLINE: This is a randomized, controlled, open-label, multicenter study. Patients are stratified according to prior adjuvant endocrine therapy (yes vs no). Patients are randomized to 1 of 3 treatment arms. * Arm I: Patients receive fulvestrant intramuscularly on days 1 and 15 of course 1 and then on day 1 only in all subsequent courses. * Arm II: Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, 15, and 22. * Arm III: Patients receive fulvestrant as in arm I in combination with trastuzumab as in arm II. In all arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 8 weeks. PROJECTED ACCRUAL: A total of 120 patients (40 per treatment arm) will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States
Cancer Care Associates Medical Group, Inc
Redondo Beach, California, United States
Unnamed facility
San Antonio, Texas, United States
Progression-free Survival
Of the two treated patients on this trial, the records show that one patient who received Herceptin only completed 3 cycles of therapy, while the second patient who received Herceptin in combination with Faslodex completed 9 cycles of therapy. The last survival data collected from October to November 2008 showed that these two participants were alive at that time.
Time frame: 5 years
Overall Objective Response Rate
Two patients were treated on a truncated trial. Not enough data was generated for any analysis.
Time frame: 5 years
Time to Tumor Progression
Two patients were treated on a truncated trial. Not enough data was generated for any analysis.
Time frame: 5 years
Duration of Response
Two patients were treated on a truncated trial. Not enough data was generated for any analysis.
Time frame: 5 years
Overall Survival
Two patients were treated on a truncated trial. Not enough data was generated for any analysis.
Time frame: 5 years
Clinical Benefit (CR + PR + SD > 6 Months)
Two patients were treated on a truncated trial. Not enough data was generated for any analysis.
Time frame: 5 years
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