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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

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

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220406
Enrollment
Unknown
Registered
2007-06-20
Start date
2007-06-20
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Breast Cancer

Interventions

investigational material(s) Generic name etc : Goserelin acetate INN of investigational material : Therapeutic category code : 249 Other hormone preparations (including antihormone preparations) Dosa

Sponsors

AstraZeneca
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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.—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026