To Compare ZOLADEX [amount hidden] With ZOLADEX [amount hidden] in Chinese Pre-menopausal ER+ HER2- Early Breast Cancer.

What Was Tested

The trial (phase 3) is built around Goserelin.

This study will recruit 168 patients in approximately 20 study centres in China.

It had two arms (groups): one (experimental) and one (active comparator).

The registry classes the interventions as drug.

More on the Plan

Eligible patients, as judged by the Investigator after completion of the screening tests, will be registered for this study and at the same time randomised in a 1:1 ratio to receive one of the following treatments.

Who Took Part

It was open to women only aged from 18 years up to 59 years.

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

Examples of who could join: Provision of informed consent prior to any study specific procedures. Women aged ≥18 at screening, in pre-menopausal status defined as:. Menses within 1 year before enrolment and within 3 weeks before enrolment, E2 \>30 pg/mL and FSH ≤40 mIU/mL. Patients who received neo/adjuvant chemotherapy before randomisation should not having chemical menopause (Patients should meet: E2\>30pg/mL and FSH ≤40mIU/mL) within 12 weeks after completion of the postoperative chemotherapy. Have had proper surgery for primary breast cancer with no known clinical residual loco regional disease.

The full record lists 9 inclusion and 27 exclusion criteria; among the exclusions: any evidence of metastatic disease; have received other previous neo/adjuvant endocrine therapy for breast cancer; other malignancy within the last 3 years except adequately treated basal cell/squamous cell carcinoma of the skin or cancer of the cervix.

How the Study Was Run

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

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

The Goserelin group and the comparison group ran side by side rather than switching.

Everyone knew when Goserelin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2020-03-31 with completion listed for 2021-11-04.

It ran at 11 sites in China (11).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 36 secondary outcomes, for example Number of participants with treatment-related adverse events as assessed by CTCAE v5.0, Change in Alanine aminotransferase(U/L), Change in Aspartate aminotransaminase(U/L), Change in Albumin(g/L), Change in Alkaline phosphatase(U/L) and Change in Calcium(mmol/L).

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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