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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00303524
Recruitment Status : Completed
First Posted : March 17, 2006
Last Update Posted : December 23, 2009
Information provided by:

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Goserelin acetate Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2006
Actual Primary Completion Date : August 2007
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Zoladex 3-month depot
Drug: Goserelin acetate
injection 10.8 mg every 3 months
Other Name: Zoladex
Experimental: 2
Zoladex 1-month depot
Drug: Goserelin acetate
Injection 3.6 mg monthly
Other Name: Zoladex

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00303524

Research Site
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
Osakasayama, Japan
Research Site
Osaka, 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
Sponsors and Collaborators
Study Director: AstraZeneca Japan Medical Director, MD AstraZeneca Identifier: NCT00303524     History of Changes
Other Study ID Numbers: D8664C00004
Zoladex EBC Study
First Posted: March 17, 2006    Key Record Dates
Last Update Posted: December 23, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents