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
Phase 2
- Conditions
- Breast Cancer
- Registration Number
- JPRN-jRCT2080220258
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
Ages Eligible for Study: 20 Years and above, Genders Eligible for Study: 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety/Efficacy 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. 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.
- Secondary Outcome Measures
Name Time Method