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

November 15, 2018 updated by: AstraZeneca

An Open Label, Randomised, Parallel Group, Multicentre Study to Compare ZOLADEX™ 10.8 mg Given Every 12 Weeks With ZOLADEX 3.6 mg Given Every 4 Weeks in Pre-menopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

222

Phase

  • Phase 3

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

  • India
      • Ahmedabad, India, 380009
        • Research Site
      • Bangalore, India, 560029
        • Research Site
      • Bangalore, India, 560090
        • Research Site
      • Chennai, India, 600010
        • Research Site
      • Hubli, India, 580025
        • Research Site
      • Hyderabad, India, 500024
        • Research Site
      • Jaipur, India, 302017
        • Research Site
      • Mumbai, India, 400012
        • Research Site
      • Nagpur, India, 440012
        • Research Site
      • New Delhi, India, 110060
        • Research Site
      • New Delhi, India, 110085
        • Research Site
      • Pune, India, 411001
        • Research Site
      • Pune, India, 411004
        • Research Site
      • Pune, India, 411005
        • Research Site
      • Thiruvananthapuram, India, 695011
        • Research Site
  • Japan
      • Amagasaki-shi, Japan, 660-8511
        • Research Site
      • Chiba, Japan, 260-8717
        • Research Site
      • Chuo-ku, Japan, 104-8560
        • Research Site
      • Fukuoka-shi, Japan, 811-1395
        • Research Site
      • Hamamatsu, Japan, 430-0906
        • Research Site
      • Hiroshima-shi, Japan, 730-8518
        • Research Site
      • Kagoshima-shi, Japan, 892-0833
        • Research Site
      • Kamogawa-shi, Japan, 296-0041
        • Research Site
      • Kitaadachi, Japan, 362-0806
        • Research Site
      • Kumamoto-shi, Japan, 862-8505
        • Research Site
      • Kyoto-shi, Japan, 602-8566
        • Research Site
      • Mitaka-shi, Japan, 181-8611
        • Research Site
      • Nagoya-shi, Japan, 464-8681
        • Research Site
      • Nagoya-shi, Japan, 465-0024
        • Research Site
      • Niigata-shi, Japan, 951-8566
        • Research Site
      • Osaka, Japan, 540-0006
        • Research Site
      • Osaka-shi, Japan, 553-0003
        • Research Site
      • Sakai-shi, Japan, 593-8304
        • Research Site
      • Sapporo-shi, Japan, 003-0804
        • Research Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 05505
        • Research Site
      • Seoul, Korea, Republic of, 135-710
        • Research Site
      • Seoul, Korea, Republic of, 139-706
        • Research Site
      • Suwon-si, Korea, Republic of, 16499
        • Research Site
  • Philippines
      • Cebu City, Philippines, 6000
        • Research Site
      • Iloilo City, Philippines, 5000
        • Research Site
      • Lipa City, Philippines, 4217
        • Research Site
      • Pasay City, Philippines
        • Research Site
      • Quezon City, Philippines
        • Research Site
      • Quezon City, Philippines, 1104
        • Research Site
  • Taiwan
      • Kaohsiung, Taiwan, 807
        • Research Site
      • Taichung, Taiwan, 40705
        • Research Site
      • Taichung, Taiwan
        • Research Site
      • Taipei, Taiwan, 10002
        • Research Site
      • Taipei, Taiwan, 11217
        • Research Site
  • Thailand
      • Bangkok, Thailand, 10330
        • Research Site
      • Bangkok, Thailand, 10400
        • Research Site
      • Bangkok, Thailand, 10700
        • Research Site
      • Maharat Nakorn Ratchasima, Thailand, 30000
        • Research Site
      • Songkla, Thailand, 90110
        • Research Site
      • Ubonratchathani, Thailand, 34000
        • 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 to 128 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female ≥20 years and pre-menopausal.Pre-menopausal defined as 1) last menses within 1 year of randomisation, and 2) E2 ≥10 pg/mL and FSH ≤ 30 mIU/mL within 4 weeks of randomisation.
  • Hormone sensitivity (ER positive) of primary or secondary tumour tissue.
  • Histological/cytological confirmation of breast cancer and are candidates to receive hormonal therapy as therapy for advanced breast cancer.

Exclusion Criteria:

  • Patients who have received tamoxifen or other hormonal therapies as adjuvant therapy for breast cancer within 24 weeks before randomisation and/or who have received prior treatment with hormonal therapies for advanced breast cancer
  • Patients who have received LHRHa as adjuvant therapy for breast cancer within 48 weeks before randomisation
  • Patients who have relapsed during adjuvant hormonal therapy or within 48 weeks after completion of adjuvant hormonal therapy and/or

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 10.8 mg (goserelin acetate) will be injected once every 12 weeks (± 7 days).

One oral tamoxifen 20 mg tablet also will be taken daily
Drug: ZD9393 (Zoladex) 10.8 mg
10.8 mg (goserelin acetate): one subcutaneous depot injection once every 12 weeks (± 7 days).
Other Names:
  • Zoladex
Active Comparator: 2
Zoladex 3.6 mg (goserelin acetate) will be injected once every 4 weeks (± 7 days). One oral tamoxifen 20 mg tablet will also be taken daily.
Drug: ZD9393 (Zoladex) 3.6 mg
3.6 mg (goserelin acetate): one subcutaneous depot injection once every 4 weeks (± 7 days).
Other Names:
  • Zoladex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With Progression-free Survival (PFS) at 24 Weeks
Time Frame: 24 weeks after the first dosing
A patient is judged as progression-free survive at Week 24 if their PFS time is at least 24 weeks with no progression event prior to Week 24 (ie, overall visit response is complete response (CR), partial response (PR) or stable disease (SD) at a tumour assessment at least 24 weeks after randomization). Overall visit response is assessed according to the RECIST version 1.1. %PFS is the proportion of patients with PFS.
24 weeks after the first dosing

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Responders at 24 Weeks
Time Frame: 24 weeks after the first dosing
Responders are defined as those patients with a best objective tumour response of CR or PR during the first 24 weeks of therapy. Tumour response is assessed according to the RECIST version 1.1. ORR is defined as the proportion of patients who are responders.
24 weeks after the first dosing
Oestradiol (E2) Serum Concentrations at 24 Weeks
Time Frame: 24 weeks after the first dosing
E2 serum concentrations (pg/mL) at 24 weeks
24 weeks after the first dosing

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Director: Justin Lindemann, PO, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Actual)

February 26, 2010

Primary Completion (Actual)

September 19, 2012

Study Completion (Actual)

November 20, 2017

Study Registration Dates

First Submitted

February 22, 2010

First Submitted That Met QC Criteria

February 22, 2010

First Posted (Estimate)

February 23, 2010

Study Record Updates

Last Update Posted (Actual)

December 12, 2018

Last Update Submitted That Met QC Criteria

November 15, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D8666C00001

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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