A randomized, double-blind, placebo-controlled, phase 3 trial comparing SMS 201-995 pa LAR plus tamoxifen versus tamoxifen plus placebo in women with locally recurrent or metastatic breast cancer.
Patients and methods: Numerous studies have proved the efficacy of tamoxifen treatment in women with receptor-positive breast cancer. Preclinical and phase I/II-studies showed that tumor control can be improved if Octreotid is added. In this randomized controlled double blind phase III study women received 20 mg tamoxifen daily and either 160 mg Octreoid-Depot i. m. injection once a month or a placebo injection. Until 1998 a total of 263 women were randomized.
Results: The study medication was tolerated well by all patients in the treatment group (n = 133). The most frequent moderate side effects were diarrhea (n = 73), nausea (n = 26), abdominal pain (n = 19), bone pain (n = 24) and fatigue (n = 20). No patient dropped out because of these side effects. Surprisingly, several complete remissions occured. Neither the total survival nor the progression free survival was significantly different between groups. Therefore the study was stopped before the originally planned number of patients (n = 416) had been enrolled.
Conclusion: Octreotid plus tamoxifen does not improve tumor control. It is necessary to define subgroups that might benefit from Octreotid.