Neoadjuvant Goserelin for Triple Negative Breast Cancer

What Was Tested

In this phase 2 trial, researchers set out to test Goserelin.

This is a phase II randomized trial that will evaluate the effect of adding LHRH analogue, goserelin, to the standard neoadjuvant chemotherapy to patients with triple negative breast cancer.

Additionally, exploring potential surrogate markers (as AR and LHRH receptors) for molecular distinct subtypes of TNBC.

It had two arms (groups): Group A (experimental) and Group B (no intervention).

The registry classes the interventions as drug.

More on the Plan

Neoadjuvant chemotherapy (NACT) is the mainstay of treatment of locally advanced TNBC and some selected early cases followed by surgery with or without adjuvant radiotherapy.

NACT is aimed to induce pathologic complete response (pCR) in tumor and lymph nodes, pCR is proofed to be a surrogate and reliable predictive factor of survival rates in TNBC.

This study will evaluate the effect of adding LHRH analogue, goserelin, to the standard neoadjuvant chemotherapy.

Following completion of neoadjuvant therapy, patients will undergo breast conservative surgery or mastectomy.

Who Took Part

180 planned participants were the target.

It was open to women only aged from 18 years up to 60 years.

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

Examples of who could join: Premenopausal women between 18 and 60 years. Histologically proven, newly diagnosed invasive carcinoma of breast. Tumors must be ER, PgR negative and HER2-neu negative. Stage II or III breast cancer that is indicated for neoadjuvant systemic chemotherapy.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: pregnant females at time of diagnosis of breast cancer; bilateral breast cancer; already received treatment for breast cancer including surgery, radiation, cytotoxic, or endocrine therapy.

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 Goserelin and who got the comparison, which limits bias.

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 2018-03 with completion listed for 2021-03.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: pathologic complete response rate (time frame: 6 months).

It also tracked 5 secondary outcomes, for example LHRH-positive and/or AR-positive Rate, Relapse-free Survival, Objective response rate, Adverse events and Ovarian failure rate.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Goserelin in 180 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.