Everolimus trIal for Advanced prememopausaL Breast Cancer Patients

What Was Tested

This registered phase 2 trial tested Goserelin.

This is a phase 2, multicentre clinical trial to evaluate the role of everolimus in the first-line endocrine treatment of premenopausal MBC patients after progression on tamoxifen.

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

Everolimus+letrozole.

Letrozole alone, and when progress, followed by everolimus.

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.

In premenopausal women with HR-positive advanced breast cancer, ovarian function suppression combined with aromatase inhibitors is a standard first-line choice of hormone treatment, especially patients progressed after tamoxifen.

Unfortunately, not all patients have a response to first-line endocrine therapy, and even patients who have a response will eventually become resistant.

An emerging mechanism of endocrine resistance in aberrant signaling through the phosphatidylinositol 3-kinase (PI3K)-Akt-mammalian target of rapamycin (mTOR) signaling pathway7-9.

Who Took Part

200 planned participants were the target.

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: Adult women (≥ 18 years of age) with metastatic or locally advanced breast cancer not amenable to curative surgery. Histological confirmation of estrogen and/or progesterone-receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2 -) breast cancer. Received Tamoxifen for at least 6 months during adjuvant treatment and recurred during or within 24 months after the end of adjuvant treatment completion,. Progressed during tamoxifen treatment for advanced disease. Pre-menopausal status was defined as either :.

The full record lists 20 inclusion and 10 exclusion criteria; among the exclusions: patients who have received endocrine treatment other than tamoxifen for adjuvant or metastatic/locally advanced breast cancer; patients who have received goserelin at adjuvant setting; patients who received more than one line of chemotherapy for metastatic or locally advanced breast cancer.

How the Study Was Run

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

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

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

Nothing was hidden in this open-label Goserelin study: the participants and staff both knew the treatment.

It started in 2014-12 with completion listed for 2016-12.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Progression free survival (time frame: 6 months after last patient was evaluated).

It also tracked 4 secondary outcomes, for example Overall survival and Number of Participants with Adverse Events as a Measure of Safety and Tolerability.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Goserelin in 200 people.

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

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