Breast Cancer Clinical Trial
Official title:
A Randomized Trial of Antiestrogen Therapy Versus Combined Antiestrogen and Octreotide Therapy in the Adjuvant Treatment of Breast Cancer in Post-Menopausal Women
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using
tamoxifen with or without octreotide may fight breast cancer by blocking the uptake of
estrogen. It is not yet known which treatment regimen is more effective for breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with or without
octreotide in treating postmenopausal women who have stage I, stage II, or stage III breast
cancer.
OBJECTIVES: I. Compare event-free, recurrence-free, and overall survival following adjuvant
therapy with tamoxifen alone vs. tamoxifen plus octreotide long-acting release formulation in
postmenopausal women with stage I/II/III breast cancer. II. Compare the toxicity and quality
of life associated with each treatment regimen. III. Compare the effects of each treatment
regimen on insulin-like growth factor-I (IGF-I) physiology, and study the relationship
between IGF-I physiology and outcome.
OUTLINE: This is a randomized study. Patients are stratified by participating institution,
when and whether they receive adjuvant chemotherapy, axillary lymph node status, and hormone
receptor status. All patients are randomized within 12 weeks of definitive surgery. Patients
receiving adjuvant chemotherapy prior to protocol treatment are randomized within 6 weeks
after the last dose of chemotherapy. One group of patients receives daily oral tamoxifen,
while a second group receives daily oral tamoxifen plus octreotide (long-acting release
formulation) by monthly depot injection. Treatment in both groups continues for 5 years or
until disease recurrence or development of a second malignancy. Patients are followed monthly
for 4 months, every 4 months for 3 years, and every 6 months thereafter.
PROJECTED ACCRUAL: A total of 850 patients will be entered over 4.2 years in this multicenter
study.
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