Trial intelligence / Profile preview

Neoadjuvant Chemotherapy With or Without GnRH Agonist for Premenopausal TNBC

NCT06225284Phase 2

Key facts

Status: Recruiting
Start: Aug 2024
Primary completion: Dec 2026
Countries: 1
Sponsor: National Taiwan University Hospital
Modality: Peptides, Small Molecules

Drugs: goserelinleuprolidetriptorelin
Conditions: triple-negative breast cancer (TNBC)

Overview

Phase 2, randomised, open-label trial of goserelin, leuprolide and triptorelin in triple-negative breast cancer (TNBC) (2 arms), sponsored by National Taiwan University Hospital. Primary endpoint: Pathological Complete Response Rate. Started Aug 2024; status: recruiting.

Design

2 arms

Study design: RandomizedOpen-label

Experimental Arm
GnRH agonist + Neoadjuvant Chemotherapy
Control Arm
Neoadjuvant Chemotherapy alone

Who it enrols

Premenopausal women with previously untreated, non-metastatic triple-negative breast cancer (T1c-T4d, N0-N2) and adequate organ function.

Endpoints

Primary

Pathological Complete Response RateDuring surgery

Secondary

Event Free SurvivalUp to 60 months
Quality of LifeUp to 5 years
Estradiol LevelsUp to 5 years
Follicle Stimulating HormoneUp to 5 years
Luteinizing HormoneUp to 5 years
Tumor Microenvironment ChangesUp to 5 years
Pathological Complete Response by Tumor Infiltrating LymphocyteDuring surgery
Residual Cancer BurdenDuring surgery

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