PersonaLized neoAdjuvant Strategy ER Positive and HER2 Negative Breast Cancer TO Increase BCS Rate

What Was Tested

This registered phase 2 trial tested Leuprolide.

It had 1 arm (groups): Arm I (experimental).

The registry classes the interventions as drug and genetic.

More on the Plan

The effect of neoadjuvant chemotherapy is different in breast cancer subtypes.

In 2017 San Antonio breast cancer symposium, Dubsky et al. reported the analysis of correlation between neoadjuvant chemotherapy and score of Endopredict(EP) multigene assay in ER+ and HER2- patients treated on ABCSG 34.

These results support the evidence that response of neoadjuvant chemotherapy or hormonal therapy can be predicted by the molecular score of tumor and selective treatment can maximize the effect.

Accordingly, in this study, patients with MammaPrint test is performed, neoadjuvant chemotherapy is conducted to genomic High Risk patients, and neoadjuvant endocrine therapy is conducted to Low Risk patients.

Who Took Part

122 planned participants were the target.

It was open to women only aged from 19 years with no upper age limit.

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

Examples of who could join: Histopathologically and immunohistochemically confirmed ER+ and HER2- BC patients. Stage I-IIIA BC patients with detectable tumor sizes. BC patients for whom BCS is not feasible due to tumor sizes or locations (two surgeons at each institution evaluate the infeasibility of BCS). Patients without distant metastasis which were identified pathologically or radiologically. Female patients ≥ 19 years.

The full record lists 16 inclusion and 14 exclusion criteria; among the exclusions: history of treatment for ipsilateral bc or breast carcinoma in situ; confirmed distant metastasis of bc; history of cancer other than bc.

How the Study Was Run

Design: single-group and open-label.

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 2019-11-08 with completion listed for 2023-10-31.

It ran at 1 site in South Korea.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Conversion Rate (time frame: 4 months(maximum 6 months)).

It also tracked 4 secondary outcomes, for example Actual Conversion Rate, pCR and cCR.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Leuprolide in 122 people.

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

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