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
Phase 2
- Conditions
- Advanced Breast Cancer
- Registration Number
- JPRN-jRCT2080220406
- 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: 18 Years and above
Genders Eligible for Study: Female
Inclusion Criteria:
- Pre-menopausal women aged 18 years or over with histologically/cytologically-confirmed oestrogen receptor positive (ER +ve) breast cancer.
- World Health Organization (WHO) performance status of 0, 1, or 2.
- Provided written informed consent.
Exclusion Criteria
- Treatment with tamoxifen or other hormonal therapies as early breast cancer (EBC) adjuvant in the previous 24 weeks.
- Received radiotherapy within the past 4 weeks.
- History of systemic malignancy other than breast cancer within the previous 3 years.
- Estimated survival less than 24 weeks
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety/Efficacy Primary Outcome Measures:- Evaluate whether Zoladex 10.8 mg (12-weekly) is non-inferior to Zoladex 3.6 mg (4-weekly) in pre-menopausal women with oestrogen receptor positive advanced breast cancer by assessment of progression-free survival. Secondary Outcome Measures:- Provide supporting data confirming that Zoladex 10.8 mg/12 weeks is non-inferior to Zoladex 3.8 mg/4 weeks. - Compare safety and tolerability of both doses. - Assess goserelin pharmacokinetics (PK) in Japanese and non-Japanese patients who have received Zoladex 10.8 mg.
- Secondary Outcome Measures
Name Time Method