Clinical trial NCT00303524: Comparative Study of Oestradiol Suppression: Zoladex 10.8mg/3 Month vs. 3.6mg/Month in ER +ve EBC Pre-menopausal Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-03-17
Enrollment: 170
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: every 12 weeks
Secondary outcomes:
measure: 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.
timeFrame: every 12 weeks
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Fukushima
country: Japan
facility: Research Site
city: Isehara
country: Japan
facility: Research Site
city: Kagoshima
country: Japan
facility: Research Site
city: Kashiwa
country: Japan
facility: Research Site
city: Kawasaki
country: Japan
facility: Research Site
city: Kitakyushu
country: Japan
facility: Research Site
city: Kumamoto
country: Japan
facility: Research Site
city: Matsuyama
country: Japan
facility: Research Site
city: Miyazaki
country: Japan
facility: Research Site
city: Nagoya
country: Japan
facility: Research Site
city: Niigata
country: Japan
facility: Research Site
city: Osakasayama
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Ota
country: Japan
facility: Research Site
city: Saitama
country: Japan
facility: Research Site
city: Shimotsuke
country: Japan
facility: Research Site
city: Suita
country: Japan
facility: Research Site
city: Tokorozawa
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
city: Utsunomiya
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Japan Medical Director, MD
role: STUDY_DIRECTOR
References: