Arimidex/Tamoxifen Neo Adjuvant Study in Premenopausal Patients With Breast Cancer Under Anti Hormonal Treatment

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00605267
• Date of registration: 09/01/2008
• Primary sponsor: AstraZeneca
• Public title: Arimidex/Tamoxifen Neo Adjuvant Study in Premenopausal Patients With Breast Cancer Under Anti Hormonal Treatment
• Scientific 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 Goserelin Acetate Treatment for Premenopausal Breast Cancer Patients
• Date of first enrolment: October 2007
• Target sample size: 197
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00605267
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Countries of recruitment

Japan

Contacts

• Name: Toshiyuki Kihara
• Affiliation: Clinical

Key inclusion & exclusion criteria

Inclusion Criteria:

- Premenopausal, estrogen receptor positive women, aged 20 years and over, with
operable and measurable breast cancer who have provided 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).



Age minimum: 20 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Drug: Anastrazole (Arimidex)

Drug: Goserelin acetate (Zoladex)

Drug: Tamoxifen

Primary Outcome(s)

Best Overall Response Rate (BORR) (Calliper) [Time Frame: 24 weeks]

Best Overall Response Rate (BORR) (MRI/CT) [Time Frame: 24 weeks]

Best Overall Response Rate (BORR) (US) [Time Frame: 24 weeks]

Secondary Outcome(s)

Anastrozole Plasma Concentrations (Cmin) [Time Frame: Assessed at week 12]

Bone Mineral Density (BMD) Cervical Thighbone [Time Frame: Assessed at baseline and after 24 weeks of treatment]

Bone Mineral Density (BMD) Lumbar Spine [Time Frame: Assessed at baseline and after 24 weeks of treatment]

Bone Turnover Marker (BAP) CLEIA Method [Time Frame: Assessed at baseline and after 24 weeks of treatment]

Bone Turnover Marker (BAP) EIA Method [Time Frame: Assessed at baseline and after 24 weeks of treatment]

Bone Turnover Marker (NTX) [Time Frame: Assessed at baseline and after 24 weeks of treatment]

Endocrine Subscale (ES) [Time Frame: Assessed at baseline and after 24 weeks of treatment]

Functional Assessment of Cancer Therapy-Breast (FACT-B) [Time Frame: Assessed at baseline and after 24 weeks of treatment]

Histopathological Response Rate (HRR) [Time Frame: Assessed at baseline and after 24 weeks of treatment]

Human Epidermal Growth Factor Receptor 2 (HER2) Status [Time Frame: Assessed at baseline and after 24 weeks of treatment]

Oestrogen Receptor (ER) Status [Time Frame: Assessed at baseline and after 24 weeks of treatment]

Progesterone Receptor (PgR) Status [Time Frame: Assessed at baseline and after 24 weeks of treatment]

Serum Oestradiol (E2) Concentrations [Time Frame: Assessed at baseline and after 24 weeks of treatment]

Serum Oestrone (E1) Concentrations [Time Frame: Assessed at baseline and after 24 weeks of treatment]

Secondary ID(s)

D539BC00001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors