Official Title: “Multi-Centre, Randomised, Double-Blind, Parallel-Group Study to Compare Efficacy and Safety Between Anastrozole (ZD1033) and Tamoxifen in Pre- and Post-Operative Administration Under Luteinising Hormone-Releasing Hormone Agonist Treatment for Premenopausal Breast Cancer Patients”

Japanese breast cancer medical experts in Japan have been strongly requesting the additional indication of anastrozole (Arimidex) for premenopausal breast cancer patients receiving an anti-hormonal, because there are no other effective endocrine therapies except tamoxifen. It is important therefore, to develop anastrozole as a new treatment option for pre-menopausal breast cancer in Japan.The primary objective of this study is to compare the tumour response rate between an anastrozole patient group and a tamoxifen group during 24 weeks pre-operative administration, for premenopausal breast cancer patients additionally receiving Zoladex 3.6mg/month. Secondary objectives include investigation of the treatment safety in the two patient groups by examination of adverse events, clinical laboratory values, blood pressure, pulse rate, and the World Health Organisation (WHO) performance status.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2010

Intervention(s) in this Clinical Trial

• Drug: Tamoxifen
  • 20 mg once daily oral dose
• Drug: Anastrazole (Arimidex)
  • 1 mg once daily oral dose
• Drug: Goserelin acetate (Zoladex)
  • 3.6mg/month depot injection

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Tamoxifen
• Experimental: 2
  • Anastrazole (Arimidex)

Primary Measures

• The primary objective of this study is to compare the tumour response rate between an anastrozole patient group and a tamoxifen group, during 24 weeks pre-operative administration, for premenopausal breast cancer patients receiving Zoladex 3.6mg/month
  • Time Frame: Assessed after 24 weeks of treatment
    Safety Issue?: No

Secondary Measures

• Safety of anastrozole and tamoxifen groups by: adverse events, lab. tests, blood pressure, pulse rate, WHO performance status and change in bone mineral density and bone turnover markers. Additional efficacy markers
  • Time Frame: Assessed after 24 weeks of treatment
    Safety Issue?: Yes

Inclusion Criteria:

• Premenopausal, estrogen receptor positive women, aged 20 years and over, with operable and measurable breast cancer who have provide written informed consent

Exclusion Criteria:

• Medical history of chemotherapy or endocrine therapy for breast cancer, or with treatment history of radiotherapy. Unwillingness to stop taking any drug known to affect sex hormone status (including hormone replacement therapy (HRT).

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Toshiyuki Kihara Study Director Clinical  

Overall Contact: Toshiyuki Kihara, MD 81 6 6453 7996 T.Kihara@astrazeneca.com

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00605267

Study ID Number: D539BC00001

ClinicalTrials.gov Identifier: NCT00605267

Health Authority: Japan: Ministry of Health, Labor and Welfare