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
- 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
- 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
In all arms, courses repeat every 28 days in the absence of disease progression or
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
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Richard J. Pietras, MD, PhD
Jonsson Comprehensive Cancer Center
United States: Food and Drug Administration
|Jonsson Comprehensive Cancer Center at UCLA||Los Angeles, California 90095-1781|
|Austin, Texas 78705|
|Cancer Care Associates Medical Group, Inc||Redondo Beach, California 90277|