Neoadjuvant Chemo-endocrine Therapy Versus Chemotherapy Alone in ER-positive, HER2-negative Breast Cancer

What Was Tested

In this phase 3 trial, researchers set out to test Leuprolide.

It had two arms (groups): neoadjuvant chemo-endocrine therapy (experimental) and neoadjuvant chemotherapy alone (active comparator).

The registry classes the interventions as drug.

More on the Plan

However this is still a controversial issue.

Who Took Part

249 actual participants took part.

It was open to women only aged from 18 years up to 70 years.

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

Examples of who could join: Estrogen receptor-positive and HER2-negative breast cancer patients, with histological stage of IIa-IIIc. Without previous chemotherapy or endocrine therapy. ECOG scores of 0-2 points. With measurable and evaluable breast tumor pathologically confirmed as invasive ductal carcinoma. Age: 18-70 years.

The full record lists 7 inclusion and 11 exclusion criteria; among the exclusions: pregnant women or nursing mothers; with distant metastasis; with mental illness or other conditions affecting the patient compliance.

How the Study Was Run

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

Because people in this Leuprolide 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 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 2013-05 with completion listed for 2017-02.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: objective response rate (ORR) (time frame: 4 years).

It also tracked 5 secondary outcomes, for example Ki67 proliferation marker changes, pathologic complete response (pCR), pathological response rate, Progression-free survival (DFS) and Incidence of Serious Treatment-Emergent Adverse Events(grade 3 or 4).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide in 249 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.