Stage IV Breast Cancer Clinical Trial
Official title:
Phase III Randomized Study of Trastuzumab (Herceptin) With or Without Tamoxifen in Women With Progressive, Stage IV, Estrogen or Progesterone Receptor- and HER2/Neu-Positive Breast Cancer
RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill
them or deliver tumor-killing substances to them without harming normal cells. Estrogen can
stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight
breast cancer by blocking the uptake of estrogen. Combining trastuzumab with tamoxifen may
kill more tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of trastuzumab with or
without trastuzumab in treating women who have invasive stage IV breast cancer.
OBJECTIVES:
- Compare time to progression in women with progressive, stage IV, estrogen or
progesterone receptor- and HER2/neu-positive breast cancer treated with trastuzumab
(Herceptin) with or without tamoxifen.
- Correlate response with type of measurement (immunohistochemistry or fluorescent in
situ hybridization) of HER2/neu expression in patients treated with these regimens.
- Compare objective response rate (complete or partial response) in patients treated with
these regimens.
OUTLINE: This is a randomized study. Patients are stratified according to prior adjuvant
treatment (yes vs no), ECOG performance status (0-1 vs 2), and prior aromatase inhibitor
treatment (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive trastuzumab (Herceptin) IV over 60-90 minutes on day 1.
- Arm II: Patients receive trastuzumab as in arm I and oral tamoxifen once daily on days
1-21.
In both arms, treatment repeats every 3 weeks for at least 2 courses in the absence of
disease progression or unacceptable toxicity.
Patients are followed every 3 months for 5 years.
PROJECTED ACCRUAL: A total of 280 patients (140 per treatment arm) will be accrued for this
study within 28 months.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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