Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Menopause

All Drugs and Chemicals

Antineoplastic Agents

Estrogens

Goserelin

Antineoplastic Agents, Hormonal

• ZOLADEX 10.8 mg depot group: subcutaneous depot injection once every 12 weeks

• ZOLADEX 3.6 mg depot group: subcutaneous depot injection once every 4 weeks

10.8 mg depot for injection (equivalent to 10.8 mg goserelin)

ZOLADEX 10.8 mg

3.6 mg depot for injection (equivalent to 3.6 mg goserelin)

ZOLADEX 3.6mg

Zefei JIANG

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

The primary objective of this study is to examine whether ZOLADEX 10.8 mg depot is non-inferior to ZOLADEX 3.6 mg depot in terms of the suppression rate of serum estradiol (E2) to the menopausal level (≤30 pg/mL) from Week 4 through Week 24.

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

This open label, randomised, parallel group, multicentre study in Chinese pre menopausal patients with ER+/HER2- early breast cancer will be conducted to determine whether 3 monthly ZOLADEX 10.8 mg injection is non-inferior to monthly ZOLADEX 3.6 mg injection in terms of estradiol (E2) suppression. The study will also assess the PK, pharmacodynamics (PD), safety and tolerability of two difference strengths of ZOLADEX.

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. The study treatment must start within 7 days after randomisation.

* ZOLADEX 10.8 mg depot group: subcutaneous depot injection once every 12 weeks
* ZOLADEX 3.6 mg depot group: subcutaneous depot injection once every 4 weeks

The primary objective:

- To examine whether ZOLADEX 10.8 mg depot is non-inferior to ZOLADEX 3.6 mg depot in terms of the suppression rate of serum estradiol (E2) to the menopausal level (≤30 pg/mL) from Week 4 through Week 24.

The secondary objectives:

* To evaluate the safety and tolerability profiles of ZOLADEX 10.8 mg depot and ZOLADEX 3.6 mg depot.
* To evaluate the estradiol (E2) suppression by assessment of area under the curve (AUC) of E2 serum concentration during the 24 weeks of treatment.
* To evaluate the goserelin pharmacokinetics (PK) in Chinese patients after injection of ZOLADEX 10.8 mg depot and ZOLADEX 3.6 mg depot.
* To assess the influence on menstruous condition after injection of ZOLADEX 10.8 mg depot or ZOLADEX 3.6 mg depot.
* To assess the hormonal conditions after injection of ZOLADEX 10.8 mg depot compared with ZOLADEX 3.6 mg depot.

To Compare ZOLADEX 10.8 mg With ZOLADEX 3.6mg in Chinese Pre-menopausal ER+ HER2- Early Breast Cancer.

An Open Label, Randomised, Parallel Group, Multicentre, Non-inferiority Study to Compare ZOLADEX 10.8 mg With ZOLADEX 3.6 mg in Chinese Pre-menopausal Patients With Estrogen Receptor-Positive and HER2 Negative Early Breast Cancer

Percentage of participants with suppressive effect of mean serum estradiol (E2) (from 4th week to 24th week) to menopausal level (≤30 pg/mL).

All AE data will be listed and the treatment-emergence status will be flagged in the listing.

Data for Alanine aminotransferase recorded in the eCRF will be listed and summarized by treatment group and visit.

Data for Aspartate aminotransaminase recorded in the eCRF will be listed and summarized by treatment group and visit.

Data for Albumin recorded in the eCRF will be listed and summarized by treatment group and visit.

Data for Alkaline phosphatase recorded in the eCRF will be listed and summarized by treatment group and visit.

Data for Calcium recorded in the eCRF will be listed and summarized by treatment group and visit.

Data for Creatinine recorded in the eCRF will be listed and summarized by treatment group and visit.

Data for High density lipoprotein cholesterol recorded in the eCRF will be listed and summarized by treatment group and visit.

Data for Inorganic phosphate recorded in the eCRF will be listed and summarized by treatment group and visit.

Data for Low density lipoprotein cholesterol recorded in the eCRF will be listed and summarized by treatment group and visit.

Data for Plasma glucose recorded in the eCRF will be listed and summarized by treatment group and visit.

Data for Potassium recorded in the eCRF will be listed and summarized by treatment group and visit.

Data for Lactate dehydrogenase recorded in the eCRF will be listed and summarized by treatment group and visit.

Data for Triglyceride recorded in the eCRF will be listed and summarized by treatment group and visit.

Data for Sodium recorded in the eCRF will be listed and summarized by treatment group and visit.

Data for Total bilirubin recorded in the eCRF will be listed and summarized by treatment group and visit.

Data for Total cholesterol recorded in the eCRF will be listed and summarized by treatment group and visit.

Data for Absolute neutrophil count recorded in the eCRF will be listed and summarized by treatment group and visit.

Data for Haematocrit recorded in the eCRF will be listed and summarized by treatment group and visit.

Data for Haemoglobin recorded in the eCRF will be listed and summarized by treatment group and visit.

Data for Mean cell volume recorded in the eCRF will be listed and summarized by treatment group and visit.

Data for Platelet count recorded in the eCRF will be listed and summarized by treatment group and visit.

Data for White blood cell count (total) recorded in the eCRF will be listed and summarized by treatment group and visit.

Actual data and changes from baseline in Systolic blood pressure will be summarized by visit using descriptive statistics.

Actual data and changes from baseline in Diastolic blood pressure will be summarized by visit using descriptive statistics.

Actual data and changes from baseline in Heart rate will be summarized by visit using descriptive statistics.

Area under the curve (AUC) of E2 serum concentration during 24 weeks of treatment

Only for PK subgroup; derived from the individual goserelin plasma concentration-time profiles following the first dose of study drug.

Only for 3.6 mg PK subgroup; derived from the individual goserelin plasma concentration-time profiles following the first dose of study drug.

Only for 10.8 mg PK subgroup; derived from the individual goserelin plasma concentration-time profiles following the first dose of study drug.

Goserelin plasma concentration of pre-dose sample during multiple dose period.

The proportion of subjects who had menstruation at each time point will be summarized by treatment group.

E2 concentration at each visit will be listed and summarized for each treatment group using descriptive statistics. Mean E2 concentration versus time plots and individual FSH concentration versus time plots will be presented.

FSH concentration at each visit will be listed and summarized for each treatment group using descriptive statistics. Mean FSH concentration versus time plots and individual FSH concentration versus time plots will be presented.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
To Compare ZOLADEX 10.8 mg With ZOLADEX 3.6mg in Chinese Pre-menopausal ER+ HER2- Early Breast Cancer.	NCT03658213	Breast Cancer	ZOLADEX 10.8 mg ZOLADEX 3.6mg	18 Years - 59 Years	AstraZeneca
To Compare ZOLADEX 10.8 mg With ZOLADEX 3.6mg in Chinese Pre-menopausal ER+ HER2- Early Breast Cancer.	NCT03658213	Breast Cancer	ZOLADEX 10.8 mg ZOLADEX 3.6mg	18 Years - 59 Years	AstraZeneca

Spots Global Cancer Trial Database for zoladex 10.8 mg