Tamoxifen With or Without Octreotide in Treating Postmenopausal Women With Stage I, Stage II, or Stage III Breast Cancer

What Was Tested

This registered phase 3 trial tested Octreotide.

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 had two arms (groups): Octreotide (active comparator) and Tamoxifen (active comparator).

The registry classes the interventions as drug.

More on the Plan

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.

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.

Who Took Part

The registry lists 667 actual participants took part.

It was open to women only aged up to 120 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Octreotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Octreotide study did not mask who received what.

It started in 1996-09-24 with completion listed for 2007-12-07.

It ran at 40 sites in Canada (38) and United States (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Event-free survival (time frame: 6 years).

It also tracked 4 secondary outcomes, for example Recurrence-free survival, Overall survival, Insulin-like growth factor measures and Quality of Life.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Octreotide in 667 people.

With 667 participants it is a large trial for this field.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Octreotide compound page, all human trials.