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 - D8664C00008

• Conditions: oestrogen receptor ER positive advanced breast cancer ABC in pre-menopausal women; MedDRA version: 6.1Level: SOCClassification code 10029104

• Registration Number: EUCTR2005-004001-29-IT
• Lead Sponsor: ASTRAZENECA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 260

Inclusion Criteria

Pre-menopausal female patients with locally advanced or metastatic breast cancer and a World Health Organization performance status of 0, 1 or 2 who are candidates to receive hormonal therapy as therapy for advanced disease and who have provided written informed consent. Patients must not have received any treatment for early breast cancer EBC with luteinising hormone releasing hormone analogues LHRHa in the 48 weeks before administration of study drug or tamoxifen or other hormonal therapies in the 24 weeks before administration of study drug.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients who have received prior first line chemotherapy for ABC are not eligible, with the exception of patients who have received taxane- or anthracycline based first line chemotherapy providing they a have no evidence of progressive disease since the start of the chemotherapy and b still have pre-menopausal status after starting chemotherapy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified