Neoadjuvant Endocrine Therapy Combined With Chemotherapy in ER-positive, HER2-negative Stage I-III Breast Cancer

What Was Tested

The trial (phase 2) is built around Leuprolide and Goserelin.

The main questions it aims to answer are: What is the objective response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 criteria at the completion of neoadjuvant treatment?

What are the changes in Ki-67 proliferation index, pathological tumor response, pathological complete response (pCR) rate, disease-free survival (DFS), and safety profile?

It had 1 arm (groups): Experimental Drug Group (experimental).

The registry classes the interventions as drug.

More on the Plan

The investigators assessed radiological response with contrast-enhanced breast magnetic resonance imaging (MRI) at baseline, after four cycles of therapy, and after neoadjuvant treatment but before surgery.

Best radiological response was classified according to the RECIST version 1.1.

Positive values denoted shrinkage; negative values denoted growth.

A multidisciplinary team chose the type and extent of surgery after considering pretreatment disease characteristics, radiological response, patient preference, and surgical feasibility.

Who Took Part

The registry lists 36 planned participants were the target.

It was open to people of any sex aged from 18 years up to 18 years.

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

Examples of who could join: Eligible patients were aged ≥18 years. Patients were required to have stage I-III operable or locally advanced breast cancer according to the eighth edition of the American Joint Committee on Cancer staging system. Patients with clinically node-negative disease (cN0) were additionally required to have high-risk clinical features, including a primary tumor classified as cT2 or higher and/or a markedly elevated Ki67 proliferation index.

The full record lists 6 inclusion and 9 exclusion criteria; among the exclusions: previous chemotherapy or endocrine therapy for breast cancer;; pregnancy or lactation;; severe or uncontrolled infection;.

How the Study Was Run

It was run as a single-group and open-label study.

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2026-09-30 with completion listed for 2028-09-30.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Objective Response Rate (ORR) (time frame: At the end of Cycle 4 and prior to surgery (each cycle is 21 days)).

It also tracked 5 secondary outcomes, for example pCR, Pathological Response, Paired change in Ki67 between biopsy and surgery, Disease-Free Survival (DFS) and Treatment-related adverse events (TRAEs).

What This Means in Plain Language

Put simply, this is a phase 2 trial of Leuprolide and Goserelin in 36 people.

Its size is small, so on its own it can only give an early look.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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