Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer

What Was Tested

The trial (phase 3) is built around Triptorelin.

It had two arms (groups): T+OFS (active comparator) and E+OFS (experimental).

The registry classes the interventions as drug.

More on the Plan

Patients are stratified according to planned use of concurrent adjuvant chemotherapy (yes vs no), and number of positive lymph nodes (0 vs 1 or more).

Treatment duration is 5 years.

Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter.

Quality of life is assessed at baseline, every 6 months for 2 years, and annually for 3 years.

Who Took Part

The registry lists 2672 actual participants took part.

It was open to women only aged from 18 years up to 65 years.

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

Examples of who could join: Completely resected disease. No clinically detectable residual loco-regional axillary disease. Total mastectomy with or without adjuvant radiotherapy. Tumor detected in internal mammary chain nodes by sentinel node procedure and is not enlarged is allowed. Axillary lymph node dissection or a negative axillary sentinel node biopsy required.

The full record lists 62 inclusion and 0 exclusion criteria.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Triptorelin and who got the comparison, which limits bias.

The Triptorelin group and the comparison group ran side by side rather than switching.

Everyone knew when Triptorelin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2003-11-03 with completion listed for 2011-03-11.

It ran at 228 sites in United States (139), Australia (20), Germany (15), Switzerland (13), Italy (12) and Canada (9).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Disease-free Survival (time frame: 5-year estimate reported at a median follow-up of 72 months).

It also tracked 3 secondary outcomes, for example Distant Recurrence-free Interval and Overall Survival.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Triptorelin in 2672 people.

With 2672 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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