Study of GnRH-A [Leuprorelin(Lorelin Depot] Plus Leterozole +/- Everolimus for Premenopausal Women With Metastatic Breast Cancer

What Was Tested

The trial (phase 2) is built around Leuprolide.

It had two arms (groups): Everolimus arm (experimental) and Control arm (active comparator).

The registry classes the interventions as drug.

More on the Plan

Endocrine therapy is the cornerstone of treatment for patients with hormone receptor (HR)-positive advanced breast cancer.

The goal of endocrine treatment is to block or interfere with the function of estrogen or progesterone.

The major source of estrogen in premenopausal women is the ovaries.

In premenopausal women with HR-positive advanced breast cancer, tamoxifen, ovarian function suppression or a combination of those have been used.

Who Took Part

Enrollment: 137 actual participants took part.

It was open to women only aged from 20 years with no upper age limit.

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

Examples of who could join: Age ≥ 20 years. Histologically or cytologically confirmed, HER-2 negative breast cancer with recurrent or metastatic disease. No HER2 overexpressing breast cancer. Premenopausal status, defined as either. ER and/or PR positive.

The full record lists 12 inclusion and 10 exclusion criteria; among the exclusions: pregnant women or patients in lactation; more than one line of prior chemotherapy for metastatic breast cancer; gnrh agonist with tamoxifen treatment within 2 weeks.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Leuprolide group and the comparison group should start out alike.

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

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

It started in 2014-01 with completion listed for 2018-10.

It ran at 1 site in South Korea.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Progression free survival (PFS) (time frame: Participants will be followed every 8 weeks , up to 12 Months).

It also tracked 1 secondary outcome, for example Overall Response rate.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Leuprolide in 137 people.

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

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