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
- 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
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
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.
Primary Purpose: Treatment
Joanne E. Mortimer, MD
Sentara Cancer Center
United States: Federal Government