--- title: "Comparative Study of Oestradiol Suppression: Zoladex 10.8mg/3 Month vs. 3.6mg/Month in ER +ve EBC Pre-menopausal Patients" nct_id: NCT00303524 overall_status: COMPLETED phase: PHASE2 sponsor: AstraZeneca study_type: INTERVENTIONAL primary_condition: Breast Cancer countries: Japan canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00303524.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00303524" ct_last_update_post_date: 2009-12-23 last_seen_at: "2026-05-12T06:11:42.885Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # 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 **NCT ID:** [NCT00303524](https://clinicaltrials.gov/study/NCT00303524) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 170 - **Lead Sponsor:** AstraZeneca - **Conditions:** Breast Cancer - **Start Date:** 2006-02 - **Completion Date:** 2009-02 - **CT.gov Last Update:** 2009-12-23 ## 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 - **Minimum age:** 20 Years - **Sex:** FEMALE - **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 ``` ## Arms - **1** (EXPERIMENTAL) — Zoladex 3-month depot - **2** (EXPERIMENTAL) — Zoladex 1-month depot ## Interventions - **Goserelin acetate** (DRUG) — Injection 3.6 mg monthly - **Goserelin acetate** (DRUG) — injection 10.8 mg every 3 months ## Primary Outcomes - **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 Outcomes - **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)_ ## Locations (22) - 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, Ōta-ku, Japan - Research Site, Saitama, Japan - Research Site, Sayama, Japan - Research Site, Shimotsuke, Japan - Research Site, Suita, Japan - Research Site, Tokorozawa, Japan - Research Site, Tokyo, Japan - Research Site, Utsunomiya, Japan ## Recent Field Changes (last 30 days) - `design.phases` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.research site|chiba||japan` — added _(2026-05-12)_ - `locations.research site|fukuoka||japan` — added _(2026-05-12)_ - `locations.research site|fukushima||japan` — added _(2026-05-12)_ - `locations.research site|isehara||japan` — added _(2026-05-12)_ - `locations.research site|kagoshima||japan` — added _(2026-05-12)_ - `locations.research site|kashiwa||japan` — added _(2026-05-12)_ - `locations.research site|kawasaki||japan` — added _(2026-05-12)_ - `locations.research site|kitakyushu||japan` — added _(2026-05-12)_ - `locations.research site|kumamoto||japan` — added _(2026-05-12)_ - `locations.research site|matsuyama||japan` — added _(2026-05-12)_ - `locations.research site|miyazaki||japan` — added _(2026-05-12)_ - `locations.research site|nagoya||japan` — added _(2026-05-12)_ - `locations.research site|niigata||japan` — added _(2026-05-12)_ - `locations.research site|osaka||japan` — added _(2026-05-12)_ - `locations.research site|ōta-ku||japan` — added _(2026-05-12)_ - `locations.research site|saitama||japan` — added _(2026-05-12)_ - `locations.research site|sayama||japan` — added _(2026-05-12)_ - `locations.research site|shimotsuke||japan` — added _(2026-05-12)_ - `locations.research site|suita||japan` — added _(2026-05-12)_ - `locations.research site|tokorozawa||japan` — added _(2026-05-12)_ - `locations.research site|tokyo||japan` — added _(2026-05-12)_ - `locations.research site|utsunomiya||japan` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00303524.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00303524* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*