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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00605267
First received: January 9, 2008
Last updated: August 3, 2012
Last verified: August 2012
Results First Received: November 26, 2010  
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
Condition: Breast Cancer
Interventions: Drug: Tamoxifen
Drug: Anastrazole (Arimidex)
Drug: Goserelin acetate (Zoladex)

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Anastrozole 1 mg Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
Tamoxifen 20 mg Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
Total Total of all reporting groups

Baseline Measures
    Anastrozole 1 mg     Tamoxifen 20 mg     Total  
Number of Participants  
[units: participants]
  98     99     197  
Age, Customized  
[units: Participants]
     
20-29 years     2     0     2  
30-39 years     21     20     41  
40-49 years     65     68     133  
50-59 years     10     11     21  
Gender  
[units: Participants]
     
Female     98     99     197  
Male     0     0     0  



  Outcome Measures
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1.  Primary:   Best Overall Response Rate (BORR) (Calliper)   [ Time Frame: 24 weeks ]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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