A RANDOMIZED TRIAL OF ANTIESTROGEN THERAPY VERSUS COMBINED ANTIESTROGEN AND OCTREOTIDE LAR THERAPY IN THE ADJUVANT TREATMENT OF BREAST CANCER IN POST-MENOPAUSAL WOMEN
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Event-free survival
6 years
No
Michael N. Pollak, MD
Study Chair
Jewish General Hospital
United States: Federal Government
MA14
NCT00002864
August 1996
April 2010
Name | Location |
---|---|
St. Mary's/Duluth Clinic Health System | Duluth, Minnesota 55805 |
Duluth Clinic | Duluth, Minnesota 55805 |