Breast Cancer
Conditions
Sponsors
AstraZeneca
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Outcome results
None listed