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Protocol B-29
A Clinical Trial to Evaluate the Benefit of Adding Octreotide (SMS 201-995 PA LAR) to Tamoxifen Alone or Tamoxifen and Chemotherapy in Patients with Axillary Node-Negative, Estrogen-Receptor-Positive, Primary Invasive Breast Cancer
Specific Aims
The primary aim of this study is to determine if the addition of octreotide (SMS 201-995 pa LAR) to tamoxifen alone or to tamoxifen in combination with chemotherapy prolongs disease-free survival (DFS) in women with axillary node-negative, estrogen-receptor-(ER)-positive breast cancer. Secondary aims include determining if the addition of octreotide prolongs survival, and if the rates of endometrial cancer and opposite breast cancer are altered by the concomitant administration of octreotide and tamoxifen. An additional secondary aim of this study is to determine accurate rates of several adverse events that have been reported in patients taking octreotide.
