Comparative Study of Oestradiol Suppression: Zoladex 10.8mg/3 Month vs. 3.6mg/Month in ER +ve EBC Pre-Menopausal Patients
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: Goserelin acetate (Drug); Goserelin acetate (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
AstraZeneca Japan Medical Director, MD, Study Director, Affiliation: AstraZeneca
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.
Clinical Details
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 design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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.
Secondary outcome: 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.
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Research Site, Fukushima, Japan
Research Site, Shimotsuke, Japan
Research Site, Utsunomiya, Japan
Research Site, Saitama, Japan
Research Site, Tokyo, Japan
Research Site, Chiba, Japan
Research Site, Ota, Japan
Research Site, Niigata, Japan
Research Site, Tokorozawa, Japan
Research Site, Kashiwa, Japan
Research Site, Fukuoka, Japan
Research Site, Kumamoto, Japan
Research Site, Miyazaki, Japan
Research Site, Kagoshima, Japan
Research Site, Isehara, Japan
Research Site, Kawasaki, Japan
Research Site, Nagoya, Japan
Research Site, Suita, Japan
Research Site, Osaka, Japan
Research Site, Osakasayama, Japan
Research Site, Matsuyama, Japan
Research Site, Kitakyushu, Japan
Additional Information
Starting date: February 2006
Ending date: March 2009
Last updated: December 15, 2007
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