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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00303524
• Other study ID #: D8664C00004
• Secondary ID: Zoladex EBC Stud
• Status: Completed
• Phase: Phase 2
• First received: March 16, 2006
• Last updated: December 20, 2009
• Start date: February 2006
• Est. completion date: February 2009

Study information

• Verified date: December 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: February 2009
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• Goserelin acetate
Injection 3.6 mg monthly
• Goserelin acetate
injection 10.8 mg every 3 months

Locations

Country	Name	City	State
Japan	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	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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		every 12 weeks	No
Secondary	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.		every 12 weeks	No