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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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from 4 research sites in Japan: Hakata (Fukuoka), Kumamoto (Kumamoto), Nagoya (Nagoya), Osaka (Osaka). The study initiation date was October 2007 and the study completion date was January 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 197 participants were recruited into this study and 98 were randomized to Anastrozole (20 mg once daily oral dose) and 99 were randomized to Tamoxifen (1 mg once daily oral dose) with one subject voluntarily discontinuing prior to receiving treatment Tamoxifen.

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

Participant Flow:   Overall Study
    Anastrozole 1 mg     Tamoxifen 20 mg  
STARTED     98     99  
COMPLETED     95 [1]   90 [1]
NOT COMPLETED     3     9  
Adverse Event                 0                 1  
Lack of Efficacy                 1                 5  
Withdrawal by Subject                 2                 3  
[1] Breast surgery performed



  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.
No text entered.

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 ]
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Measure Type Primary
Measure Title Best Overall Response Rate (BORR) (Calliper)
Measure Description

The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period (based on the data from calliper measurement).

CR (or PR) criteria are met at 2 or more time in points every 4 weeks. Per RECIST Criteria (V1.0) and assessed by Calliper: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Time Frame 24 weeks  
Safety Issue No  

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.

The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period.

At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter


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

Measured Values
    Anastrozole 1 mg     Tamoxifen 20 mg  
Number of Participants Analyzed  
[units: participants]
  98     99  
Best Overall Response Rate (BORR) (Calliper)  
[units: Percentage¬†of¬†Participants]
  70.4     50.5  

No statistical analysis provided for Best Overall Response Rate (BORR) (Calliper)



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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