Trials Sponsors Conditions Drugs Pricing

Conditions

Breast Cancer

Keywords

Early breast cancerGoserelin acetateEstrogen suppressionPre-menopausalZoladex

Outcome Measures

Primary Outcomes (1)

Effective inhibition rate of serum estradiol(E2)
Percentage of participants with suppressive effect of mean serum estradiol (E2) (from 4th week to 24th week) to menopausal level (≤30 pg/mL).
At scheduled visits from Week 4 through Week 24.

Secondary Outcomes (36)

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
From screening to 4 weeks after the completion of 24 weeks treatment period.
Change in Alanine aminotransferase(U/L)
At scheduled visits from screening to 24th week.
Change in Aspartate aminotransaminase(U/L)
At scheduled visits from screening to 24th week.
Change in Albumin(g/L)
At scheduled visits from screening to 24th week.
Change in Alkaline phosphatase(U/L)
At scheduled visits from screening to 24th week.
+31 more secondary outcomes

Study Arms (2)

ZOLADEX 10.8 mg depot group

EXPERIMENTAL

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

Drug: ZOLADEX 10.8 mg

ZOLADEX 3.6 mg depot group

ACTIVE COMPARATOR

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

Drug: ZOLADEX 3.6mg

Interventions

ZOLADEX 10.8 mgDrug

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

Also known as: ZOLADEX® (goserelin acetate implant) 10.8 mg

ZOLADEX 10.8 mg depot group

ZOLADEX 3.6mgDrug

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

Also known as:

Eligibility Criteria

Age18 Years - 59 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Provision of informed consent prior to any study specific procedures.
Women aged ≥18 at screening, in pre-menopausal status defined as:

Sponsors & Collaborators

AstraZeneca
Industrylead

Study Sites (11)

Research Site

Beijing, 100006, China

Research Site

Chengdu, 610041, China

Research Site

Guangzhou, 510060, China

Research Site

Guangzhou, 510100, China

Research Site

Hangzhou, 310009, China

Research Site

Hangzhou, 310022, China

Research Site

Harbin, 150081, China

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Goserelin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormones

Study Officials

Zefei JIANG
307 Hospital of PLA
PRINCIPAL INVESTIGATOR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 27, 2018

First Posted

September 5, 2018

Study Start

March 31, 2020

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (36)

Study Arms (2)

ZOLADEX 10.8 mg depot group

ZOLADEX 3.6 mg depot group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (11)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (36)

Study Arms (2)

ZOLADEX 10.8 mg depot group

ZOLADEX 3.6 mg depot group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (11)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations