Comparative Study of Oestradiol Suppression: Zoladex 10.8mg/3 Month vs. 3.6mg/Month in ER +ve EBC Pre-menopausal Patients

December 20, 2009 updated by: AstraZeneca

An Open-label, Randomized, Parallel Group, Multicentre Study to Compare Oestradiol Suppression Between ZOLADEX 10.8 mg Depot Given 3 Monthly and ZOLADEX 3.6 mg Depot Given Monthly in Pre-menopausal Patients With ER Positive Early Breast Cancer

The primary purpose of this study is to establish if a 10.8 mg dose of ZOLADEX given 3 monthly is non-inferior to a 3.6 mg dose of ZOLADEX given monthly in terms of oestradiol suppression in patients with oestrogen receptor positive early breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

170

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chiba, Japan
        • Research Site
      • Fukuoka, Japan
        • Research Site
      • Fukushima, Japan
        • Research Site
      • Isehara, Japan
        • Research Site
      • Kagoshima, Japan
        • Research Site
      • Kashiwa, Japan
        • Research Site
      • Kawasaki, Japan
        • Research Site
      • Kitakyushu, Japan
        • Research Site
      • Kumamoto, Japan
        • Research Site
      • Matsuyama, Japan
        • Research Site
      • Miyazaki, Japan
        • Research Site
      • Nagoya, Japan
        • Research Site
      • Niigata, Japan
        • Research Site
      • Osaka, Japan
        • Research Site
      • Osakasayama, Japan
        • Research Site
      • Ota, Japan
        • Research Site
      • Saitama, Japan
        • Research Site
      • Shimotsuke, Japan
        • Research Site
      • Suita, Japan
        • Research Site
      • Tokorozawa, Japan
        • Research Site
      • Tokyo, Japan
        • Research Site
      • Utsunomiya, Japan
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pre-menopausal women aged 20 years or over with histological/cytologically-confirmed ER +ve breast cancer who have undergone radical surgery and WHO performance status 0,1 or 2.

Exclusion Criteria:

  • Evidence of metastatic disease, previous bilateral oophorectomy or radiotherapy to the ovaries, previous chemotherapy, breast surgery completed over 12 weeks before starting trial treatment, previous neo-adjuvant/adjuvant hormonal breast cancer therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Zoladex 3-month depot
Drug: Goserelin acetate
Injection 3.6 mg monthly
Other Names:
  • Zoladex
Drug: Goserelin acetate
injection 10.8 mg every 3 months
Other Names:
  • Zoladex
Experimental: 2
Zoladex 1-month depot
Drug: Goserelin acetate
Injection 3.6 mg monthly
Other Names:
  • Zoladex
Drug: Goserelin acetate
injection 10.8 mg every 3 months
Other Names:
  • Zoladex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Zoladex 10.8mg depot (every 12 weeks) is non-inferior to Zoladex 3.6mg depot (every 4 weeks) in terms of oestradiol (E2) suppression in patient population by assessment of area under the curve of E2 concentration during the first 24 weeks of treatment.
Time Frame: every 12 weeks
every 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Zoladex 10.8mg has similar safety and tolerability profile to Zoladex 3.6mg. Examination of goserelin pharmacokinetics (PK) in Japanese patients after injection of Zoladex 10.8mg. Efficacy of Zoladex 10.8mg is similar to 3.6mg by assessment of DFS.
Time Frame: every 12 weeks
every 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: AstraZeneca Japan Medical Director, MD, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

March 16, 2006

First Submitted That Met QC Criteria

March 16, 2006

First Posted (Estimate)

March 17, 2006

Study Record Updates

Last Update Posted (Estimate)

December 23, 2009

Last Update Submitted That Met QC Criteria

December 20, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D8664C00004
  • Zoladex EBC Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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