An Open Label, Randomised, Parallel Group, Multicentre Study to Compare ZOLADEX™ 10.8 mg Given Every 12 Weeks With ZOLADEX 3.6 mg Given Every 4 Weeks in Pre-menopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer
20 Years
N/A
Female
Breast Cancer
Trial Information
An Open Label, Randomised, Parallel Group, Multicentre Study to Compare ZOLADEX™ 10.8 mg Given Every 12 Weeks With ZOLADEX 3.6 mg Given Every 4 Weeks in Pre-menopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer
Inclusion Criteria:
- Female ≥20 years and pre-menopausal.Pre-menopausal defined as 1) last menses within 1
year of randomisation, and 2) E2 ≥10 pg/mL and FSH ≤ 30 mIU/mL within 4 weeks of
randomisation. For patients who have had a hysterectomy, it is acceptable to meet
only
- Hormone sensitivity (ER positive) of primary or secondary tumour tissue.
- Histological/cytological confirmation of breast cancer and are candidates to receive
hormonal therapy as therapy for advanced breast cancer.
Exclusion Criteria:
- Patients who have received tamoxifen or other hormonal therapies as adjuvant therapy
for breast cancer within 24 weeks before randomisation and/or who have received prior
treatment with hormonal therapies for advanced breast cancer
- Patients who have received LHRHa as adjuvant therapy for breast cancer within 48
weeks before randomisation
- Patients who have relapsed during adjuvant hormonal therapy or within 48 weeks after
completion of adjuvant hormonal therapy and/or
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Efficacy: The primary outcome variable is Progression Free Survival (PFS) at 24 weeks. A PF patient is defined as a patient for whom neither objective disease progression nor death (due to any cause) has been observed
Outcome Time Frame:
At baseline, at week 12 and at week 24
Safety Issue:
No
Principal Investigator
Justin Lindemann, PO
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
D8666C00001
NCT ID:
NCT01073865
Start Date:
February 2010
Completion Date:
July 2014
Related Keywords:
- Breast Cancer
- ZOLADEX
- Pre-menopausal
- Oestrogen Receptor
- Advanced Breast Cancer
- Progression Free Survival
- Breast Neoplasms
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