Neoadjuvant Chemotherapy With or Without GnRH Agonist for Premenopausal Triple-negative Early Breast Cancer Patients

What Was Tested

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

Breast cancer (BC), especially premenopausal, is emerging rapidly in East Asia in recent 20 years.

Half of the breast cancer patients in Asia are younger than 50 years of age.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 124 planned participants were the target.

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: Written informed consent must be obtained before any assessment is performed. Female patients aged ≥ 18 years at screening; Must be premenopausal according to serum E2, FSH level. Agree to receive core needle biopsy for translational research. Patients must have adequate organ and marrow reserve measured within 14 days prior to randomization as defined below:. Absolute neutrophil count ≥ 1,500 /μL;.

The full record lists 18 inclusion and 19 exclusion criteria; among the exclusions: patients have received any prior therapy (including surgery, radiotherapy, chemotherapy, immunotherapy, or hormone therapy) for breast cancer; evidence of systemic metastasis; pregnancy or lactation.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Leuprolide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Leuprolide study did not mask who received what.

It started in 2024-08-22 with completion listed for 2026-12.

It ran at 1 site in Taiwan.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Pathological complete response rate (time frame: During surgery).

It also tracked 11 secondary outcomes, for example Event free survival, Quality of life from patient-report outcome, Estradiol, Follicle stimulating hormone, Luteinizing hormone and Tumor microenvironment changes after neoadjuvant chemotherapy with/without ovarian suppression.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Leuprolide and Goserelin in 124 people.

It is still 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.