HOBOE: A Phase 3 Study of Adjuvant Triptorelin and Tamoxifen, Letrozole, or Letrozole and Zoledronic Acid in Premenopausal Patients With Breast Cancer.

What Was Tested

This registered phase 3 trial tested Triptorelin.

The HOBOE study was amended in November 2009, and, after reaching enrollment of the first 500 patients, the study began recruiting premenopausal patients only.

Patients receive triptorelin and are randomized in a 1:1:1 fashion to receive tamoxifen or letrozole, or letrozole + zoledronic acid.

It had three arms (groups): A (active comparator), B (active comparator) and C (experimental).

The registry classes the interventions as drug.

Who Took Part

1294 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

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

Examples of who could join: No evidence of disease. Patient age at least 18 years.

The full record lists 6 inclusion and 14 exclusion criteria; among the exclusions: performance status (ecog)\>2; creatinine \> 1.25 times the value of upper normal limit; pregnant or lactating females.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Triptorelin 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 Triptorelin study did not mask who received what.

It started in 2004-03 with completion listed for 2024-11.

It ran at 20 sites in Italy (20).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): disease free survival in premenopausal patients (time frame: observation period is 10 years from initiation of treatment). bone mineral density (time frame: 12 months from initiation of therapy).

It also tracked 4 secondary outcomes, for example Bone mineral density measured, disease free survival in postmenopausal patients, overall survival and toxicity of letrozole + triptorelin and letrozole + zoledronic acid + triptorelin in premenopausal patients.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Triptorelin in 1294 people.

With 1294 participants it is a large trial for this field.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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