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Study to Compare Zoladex™ 10.8 mg With Zoladex 3.6 mg in Pre-menopausal Women With Breast Cancer

NCT01073865 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2018-12-12

Study results available
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Summary

The purpose of this study is to examine the efficacy and safety as well as the characteristics of the female hormone and study medications after administration in pre-menopausal women with estrogen receptor positive advanced breast cancer who were randomised in a 1:1 ratio to either of the two treatment groups; the ZD9393 3.6 mg depot group or ZD9393 10.8 mg depot group, both given in combination with tamoxifen tablets.

Conditions

Interventions

DRUG

ZD9393 (Zoladex) 10.8 mg

10.8 mg (goserelin acetate): one subcutaneous depot injection once every 12 weeks (± 7 days).

DRUG

ZD9393 (Zoladex) 3.6 mg

3.6 mg (goserelin acetate): one subcutaneous depot injection once every 4 weeks (± 7 days).

Sponsors & Collaborators

Principal Investigators

  • Justin Lindemann, PO · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
130 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-26
Primary Completion
2012-09-19
Completion
2017-11-20

Countries

  • India
  • Japan
  • Philippines
  • South Korea
  • Taiwan
  • Thailand

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01073865 on ClinicalTrials.gov