TRial on the Endocrine Activity of Neoadjuvant Degarelix

What Was Tested

In this phase 2 trial, researchers set out to test Triptorelin and Degarelix.

The purpose of the this study is to investigate the anti-tumor activity and tolerability of the study medications Degarelix and Triptorelin in premenopausal women receiving preoperative treatment with Letrozole.

It had two arms (groups): triptorelin + letrozole (experimental) and degarelix + letrozole (experimental).

The registry classes the interventions as drug.

More on the Plan

RATIONALE Preoperative chemotherapy enables breast-conserving surgery for some patients with breast cancer, and it might be advantageous in several other ways.

In particular the degree of response (pathological complete remission (pCR)) predicts overall outcome in terms of DFS.

However, pCR can be achieved only in a minority of patients with estrogen receptor (ER)-positive disease.

In premenopausal women with ER and progesterone receptor (PgR) positive breast cancer, the preoperative endocrine therapy includes a combination of a gonadotropin-releasing hormone analogue (GnRH) plus tamoxifen.

Who Took Part

Enrollment: 51 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: Age ≥ 18 years. Performance Status - Eastern Cooperative Oncology Group (ECOG) 0-1. Histologically confirmed invasive breast cancer: Primary tumor greater than 2 cm Diameter, any nodal stage, no evidence of metastasis (M0). Primary tumor must be HER2-negative (by IHC and/or ISH). Hepatic status: Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN), AST and ALT ≤ 2.5 × ULN, Alkaline phosphatase ≤ 2.5 × ULN.

The full record lists 18 inclusion and 16 exclusion criteria; among the exclusions: any hormonal treatment (e.g., oral, injectable, implant, or medicated iud) in the previous 2 months; presence of her2 overexpression or amplification; received any prior treatment for primary invasive breast cancer.

How the Study Was Run

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

The participants were allocated by chance, so the Triptorelin 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 Triptorelin study: the participants and staff both knew the treatment.

It started in 2014-02 with completion listed for 2017-08-25.

It ran at 7 sites in Italy (7).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Time to Optimal Ovarian Function Suppression (time frame: up to 24 weeks).

It also tracked 6 secondary outcomes, for example Ki67 Proliferation Marker Changes, Preoperative Endocrine Prognostic Index (PEPI) Score, Best Overall (Disease) Response, Percentage of Patients With Node-negative Disease at Surgery, Percentage of Patients Who Underwent Breast-Conserving Surgery (BCS) and Patient-reported Symptoms (PRS) Outcomes.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Triptorelin and Degarelix in 51 people.

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

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