Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer

What Was Tested

This registered phase 2 trial tested Triptorelin.

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die.

Chemoprotective drugs, such as triptorelin, may protect normal ovarian cells from the side effects of chemotherapy.

It had two arms (groups): triptorelin (experimental) and no triptorelin (no intervention).

GnRH analogue (triptorelin) during chemotherapy.

No GnRH analogue (triptorelin) during chemotherapy.

The registry classes the interventions as drug.

More on the Plan

OUTLINE: This is a randomized, multicenter study.

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

Patients are followed every 6 months for 2 years and then annually for 3 years.

PROJECTED ACCRUAL: A total of 138 patients (69 per treatment arm) will be accrued for this study within 35 months.

Who Took Part

Enrollment: 49 actual participants took part.

It was open to women only aged up to 44 years.

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

Examples of who could join: Early-stage, operable disease. Hormone receptor status:. Meets 1 of the following criteria:. Estrogen receptor (ER)- OR progesterone receptor (PR)-positive. ER- AND PR-negative.

The full record lists 40 inclusion and 10 exclusion criteria; among the exclusions: history of premature ovarian failure; over 45 years of age; first-degree relative menopausal at \< 40 years of age.

How the Study Was Run

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

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.

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 2004-07 with completion listed for 2008-05.

It ran at 9 sites in United States (9).

Its stated primary purpose is supportive care.

What Was Measured

Primary outcome: Time to Resumption of Menses (time frame: Baseline, end of chemotherapy then 5 years).

It also tracked 1 secondary outcome, for example Chemotherapy-related Amenorrhea.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Triptorelin in 49 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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