Study of Zoladex Given Every 12 Weeks Versus Given Every Month in Advanced Breast Cancer (ABC) Pre-Menopausal Women - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00322348

Purpose

The primary objective is to 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 at 24 weeks.

A temporary halt to patient recruitment was placed on the study on December 24th 2007, pending confirmation/approval from the Japanese PMDA. The meeting with the PMDA will now take place in July/August 2008.The study has been halted with a total of 97 patients randomized and it is anticipated that the study stats and CSR for the primary objective (Data at 6-months) will be based on this patient number. These patients will then be followed to the secondary endpoint at 2 years, when the final stats and CSR will be produced.

Condition	Intervention	Phase
Advanced Breast Cancer	Drug: Goserelin acetate	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Menopause

Drug Information available for: Goserelin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Further study details as provided by AstraZeneca:

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 [ Time Frame: assessed every 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Provide supporting data confirming that Zoladex 10.8 mg/12 weeks is non-inferior to Zoladex 3.8 mg/4 weeks [ Time Frame: assessed every 12 weeks ] [ Designated as safety issue: No ]
Compare safety and tolerability of both doses [ Time Frame: Assessed after each dose administration (4 or 12 weeks) ] [ Designated as safety issue: No ]
Assess goserelin pharmacokinetics (PK) in Japanese and non-Japanese patients who have received Zoladex 10.8 mg [ Time Frame: assessed every 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	260
Study Start Date:	April 2006
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Zoladex 3.6 mg	Drug: Goserelin acetate 3.6 mg intramuscular depot injection given every 4 weeks
2: Experimental Zoladex 10.8 mg	Drug: Goserelin acetate 10.8 mg intramuscular depot injection given every 12 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00322348

Show 51 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Breast Cancer Established Brands Team Medical Science Director, MD

AstraZeneca

More Information

AstraZeneca Information This link exits the ClinicalTrials.gov site

Study ID Numbers:	D8664C00008, Zoladex ABC Study
Study First Received:	May 3, 2006
Last Updated:	June 16, 2008
ClinicalTrials.gov Identifier:	NCT00322348
Health Authority:	Romania: National Medicines Agency; Japan: Ministry of Health, Labor and Welfare; Italy: National Monitoring Centre for Clinical Trials - Ministry of Health; Russia: Pharmacological Committee, Ministry of Health; Ukraine: State Pharmacological Center - Ministry of Health; Poland: Ministry of Health; Czech Republic: State Institute for Drug Control

Keywords provided by AstraZeneca:

oncology
cancer
breast cancer

Study placed in the following topic categories:

Skin Diseases
Goserelin
Breast Neoplasms
Menopause
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents, Hormonal

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009