Fulvestrant and/or Trastuzumab as First-Line Therapy in Treating Postmenopausal Women With Stage IV Breast Cancer
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Randomized Trial of Faslodex and Herceptin, Alone and Combined, in the First - Line Treatment of Hormone Receptor-Positive, HER-2/Neu-Overexpressing Metastatic Breast Cancer|
- Progression-free Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]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.
- Overall Objective Response Rate [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Time to Tumor Progression [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Duration of Response [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Clinical Benefit (CR + PR + SD > 6 Months) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||April 2005|
|Study Completion Date:||December 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Experimental: Arm I
see intervention description for details
Administered IM at 500 mg on day 1 of cycle 1, followed by 500 mg on day 15 of cycle 1, then 500 mg on day 1 of each cycle thereafter.Biological: Herceptin
Given at 4 mg/kg IV on day 1 (cycle 1) then 2mg/kg IV weekly
- 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®).
- 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.
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095-1781|
|Cancer Care Associates Medical Group, Inc|
|Redondo Beach, California, United States, 90277|
|United States, Texas|
|San Antonio, Texas, United States|
|Principal Investigator:||Richard J. Pietras, MD, PhD||Jonsson Comprehensive Cancer Center|