Neoadjuvant Endocrine Therapy Versus Chemotherapy in Premenopausal Patients With ER+ & HER2- Breast Cancer

What Was Tested

The trial (phase 3) is built around Goserelin.

It had two arms (groups): Endocrine therapy; (experimental) and Chemotherapy (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 234 planned participants were the target.

It was open to women only aged from 35 years up to 55 years.

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

Examples of who could join: 35 years old \<age≤55 years old, in premenopausal status(with the judgement by researchers when the patients are recruited) Histologically confirmed primary invasive breast cancer. Stage: T2N0M0(cT\>2cm, SLNB negative), hard to proceed the breast conserving surgery(not feasible or may affect the appearance of breast). No other previous treatment for primary breast cancer. Without other tumor or unstable complication or uncontrolled infection. No contradiction for the third generation AIs, LHRHa, chemotherapy.

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: metastasis disease by pathological or radiological diagnosis; the history of other tumor; contradiction for the third generation ais, lhrha, chemotherapy.

How the Study Was Run

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

Because people in this Goserelin 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.

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

It started in 2015-07-29 with completion listed for 2026-06-30.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: ultrasound response rate (time frame: within 2 weeks before surgery).

It also tracked 1 secondary outcome, for example pathological response rate(Miller & Payne standard).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Goserelin in 234 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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