Chidamide Combined With Exemestane (+/- Goserelin) Versus Neoadjuvant Chemotherapy in Patients of Stage II-III HR-positive/HER2-negative Breast Cancer

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Goserelin.

It had two arms (groups): Chidamide group (experimental) and chemotherapy group (active comparator).

Chidamide combined with exemestane (+/- goserelin).

Chemotherapy with docetaxel plus epirubicin or change of chemotherapy regimen (at the discretion of the clinician).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 130 planned participants were the target.

It was open to women only aged from 18 years up to 75 years.

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

Examples of who could join: Female patients aged greater than or equal to 18 years and less than or equal to 75 years, meet one of the following:. Previous oophorectomy, or age ≥ 60 years;. Premenopausal or perimenopausal female patients, must be willing to receive LHRH agonist therapy during the study;. Tumor stage II-III meeting the AJCC 8th version criteria, patients who have previously received 2 cycles of TE regimen chemotherapy, with disease evaluation of SD or PD;. KPS score ≥ 70 points;.

The full record lists 12 inclusion and 5 exclusion criteria; among the exclusions: received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);; received any other anti-tumor therapy at the same time;; breast cancer, inflammatory breast cancer or occult breast cancer;.

How the Study Was Run

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

The participants were allocated by chance, so the Goserelin group and the comparison group should start out alike.

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

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

It started in 2022-02-25 with completion listed for 2022-07-31.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: ORR (time frame: Up to approximately 48 months).

It also tracked 8 secondary outcomes, for example Residual tumor burden (RCB) classification, Total breast pathological complete remission rate (bpCR), PEPI classification, Breast-conserving rate, patient-reported outcome（PRO）：evaluate daily functioning and health outcomes from the patient's perspective by HRQOL and Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Goserelin in 130 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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