Efficacy and Safety of LY01005 in Patients With Breast Cancer Compared to ZOLADEX®

What Was Tested

This registered phase 3 trial tested Goserelin.

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

The registry classes the interventions as drug.

More on the Plan

A total of 188 patients with breast cancer who are suitable for endocrine therapy will be enrolled into the screening period from D-28 to D-1 before administration.

Blood samples will be collected at the specified time points of the study to detect serum E2, LH and FSH.

Safety evaluation (including vital signs, physical examination, laboratory tests, 12 ECG, adverse events, etc.) will be conducted as required in the protocol.

Who Took Part

Enrollment: 188 actual participants 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: Life expectancy of more than 9 months. ECOG score of ≤ 2. Patients who voluntarily sign an IRB-approved informed consent form before any trial-related activities, are willing to abide by the restrictions of the study, and complete the prescribed examinations.

The full record lists 7 inclusion and 17 exclusion criteria; among the exclusions: any evidence of distant metastatic lesions; have received any neoadjuvant /adjuvant endocrine therapy for breast cancer previously; have received a bilateral oophorectomy, ovarian radiotherapy, hypophysectomy or adrenalectomy, or who have pituitary lesions.

How the Study Was Run

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

Because people in this Goserelin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

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

It started in 2020-10-15 with completion listed for 2022-04-05.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 8 secondary outcomes, for example Incidence of adverse events (AE), Changes in serum E2 level after administration, Changes in serum LH level after administration and Changes in serum FSH level after administration.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Goserelin in 188 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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