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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
History of Changes
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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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
  Hide All Outcome Measures

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

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 ]

Measure Type Primary
Measure Title Best Overall Response Rate (BORR) (US)
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 ultra sound (US) 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 US: 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.
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

Measured Values
    Anastrozole 1 mg     Tamoxifen 20 mg  
Number of Participants Analyzed  
[units: participants]
 		  98     99  
Best Overall Response Rate (BORR) (US)  
[units: Participants]
 		  58.2     42.4  

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



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

Measure Type Primary
Measure Title Best Overall Response Rate (BORR) (MRI/CT)
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 magnetic resonance imaging (MRI) or computed tomography (CT) measurement).

CR (or PR) criteria are met at either 12 weeks or 24 weeks. Per RECIST Criteria (V1.0) and assessed by MRI or CT: 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.
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

Measured Values
    Anastrozole 1 mg     Tamoxifen 20 mg  
Number of Participants Analyzed  
[units: participants]
 		  98     99  
Best Overall Response Rate (BORR) (MRI/CT)  
[units: Percentage of Participants]
 		  64.3     37.4  

No statistical analysis provided for Best Overall Response Rate (BORR) (MRI/CT)



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

Measure Type Secondary
Measure Title Bone Mineral Density (BMD) Lumbar Spine
Measure Description Change from baseline in Bone Mineral Density value (percentage), in all subjects who used DXA(Dual-energy X-ray absorptiometry) method throughout the study, at 24 weeks measured at lumbar spine.
Time Frame Assessed at baseline and after 24 weeks of treatment  
Safety Issue Yes  

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 standard BMD value is defined by Japanese Osteoporosis Society in the table of reference values showing the mean for the age, gender, race, skeletal site, and densitometer measurement units was used. Then the formula was used at each measurement data: BMD(%) = Patient's BMD / standard BMD) x 100

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]
 		  80     78  
Bone Mineral Density (BMD) Lumbar Spine  
[units: PercentageBMD=Patient's BMD/standard BMD]
Mean ± Standard Deviation 		  -5.8  ± 3.4     -2.9  ± 2.5  

No statistical analysis provided for Bone Mineral Density (BMD) Lumbar Spine



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

Measure Type Secondary
Measure Title Bone Mineral Density (BMD) Cervical Thighbone
Measure Description Change from baseline in Bone Mineral Density value (percentage), in all subjects who used DXA(Dual-energy X-ray absorptiometry) method throughout the study, at 24 weeks measured at cervical thighbone.
Time Frame Assessed at baseline and after 24 weeks of treatment  
Safety Issue Yes  

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.
Difference of percentage Bone Mineral Density (BMD) Cervical Thighbone = BMD percentage at 24 weeks – BMD percentage at baseline

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]
 		  80     77  
Bone Mineral Density (BMD) Cervical Thighbone  
[units: PercentageBMD=Patient'sBMD/standard BMD)]
Mean ± Standard Deviation 		  -2.5  ± 5.1     -0.5  ± 3.2  

No statistical analysis provided for Bone Mineral Density (BMD) Cervical Thighbone



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

Measure Type Secondary
Measure Title Bone Turnover Marker (BAP) EIA Method
Measure Description Change from baseline in serum Bone-Alkaline Phosphatase (BAP) at 24 weeks measured by EIA method
Time Frame Assessed at baseline and after 24 weeks of treatment  
Safety Issue Yes  

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

Measured Values
    Anastrozole 1 mg     Tamoxifen 20 mg  
Number of Participants Analyzed  
[units: participants]
 		  59     60  
Bone Turnover Marker (BAP) EIA Method  
[units: U/L]
Mean ± Standard Deviation 		  7.1941  ± 6.1600     0.7333  ± 3.3640  

No statistical analysis provided for Bone Turnover Marker (BAP) EIA Method



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

Measure Type Secondary
Measure Title Bone Turnover Marker (BAP) CLEIA Method
Measure Description Change from baseline in serum Bone-Alkaline Phosphatase (BAP) at 24 weeks measured by CLEIA method
Time Frame Assessed at baseline and after 24 weeks of treatment  
Safety Issue Yes  

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

Measured Values
    Anastrozole 1 mg     Tamoxifen 20 mg  
Number of Participants Analyzed  
[units: participants]
 		  36     30  
Bone Turnover Marker (BAP) CLEIA Method  
[units: ug/L]
Mean ± Standard Deviation 		  3.96  ± 4.60     -0.75  ± 3.10  

No statistical analysis provided for Bone Turnover Marker (BAP) CLEIA Method



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

Measure Type Secondary
Measure Title Bone Turnover Marker (NTX)
Measure Description Change from baseline in serum crosslinked N-Telopeptide of type I collagen (NTX) at 24 weeks
Time Frame Assessed at baseline and after 24 weeks of treatment  
Safety Issue Yes  

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

Measured Values
    Anastrozole 1 mg     Tamoxifen 20 mg  
Number of Participants Analyzed  
[units: participants]
 		  95     89  
Bone Turnover Marker (NTX)  
[units: nmolBCE(Bone Collagen Equivalent) /L]
Mean ± Standard Deviation 		  9.17  ± 4.74     2.59  ± 3.23  

No statistical analysis provided for Bone Turnover Marker (NTX)



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

Measure Type Secondary
Measure Title Serum Oestrone (E1) Concentrations
Measure Description Ratio of serum Oestrone (E1) concentration (pg/mL) in the ITT population from baseline at 24 weeks.
Time Frame Assessed at baseline and after 24 weeks of treatment  
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.
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

Measured Values
    Anastrozole 1 mg     Tamoxifen 20 mg  
Number of Participants Analyzed  
[units: participants]
 		  96     92  
Serum Oestrone (E1) Concentrations  
[units: Ratio]
Mean ± Standard Deviation 		  0.028  ± 0.036     0.341  ± 0.282  

No statistical analysis provided for Serum Oestrone (E1) Concentrations



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

Measure Type Secondary
Measure Title Serum Oestradiol (E2) Concentrations
Measure Description Ratio of serum Oestradiol (E2) concentration (pg/mL) in the ITT population from baseline at 24 weeks.
Time Frame Assessed at baseline and after 24 weeks of treatment  
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.
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

Measured Values
    Anastrozole 1 mg     Tamoxifen 20 mg  
Number of Participants Analyzed  
[units: participants]
 		  96     92  
Serum Oestradiol (E2) Concentrations  
[units: Ratio]
Mean ± Standard Deviation 		  0.041  ± 0.092     0.082  ± 0.186  

No statistical analysis provided for Serum Oestradiol (E2) Concentrations



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

Measure Type Secondary
Measure Title Oestrogen Receptor (ER) Status
Measure Description ER status in the ITT population is categorized as Positive or Negative
Time Frame Assessed at baseline and after 24 weeks of treatment  
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.
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

Measured Values
    Anastrozole 1 mg     Tamoxifen 20 mg  
Number of Participants Analyzed  
[units: participants]
 		  94     90  
Oestrogen Receptor (ER) Status  
[units: Participants]
 		   
Baseline Positive & 24 weeks Negative     2     1  
Baseline Positive & 24 weeks Positive     92     89  
Baseline Negative & 24 weeks Negative     0     0  
Baseline Negative & 24 weeks Positive     0     0  

No statistical analysis provided for Oestrogen Receptor (ER) Status



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

Measure Type Secondary
Measure Title Progesterone Receptor (PgR) Status
Measure Description PgR status in the ITT population is categorized as Positive or Negative.
Time Frame Assessed at baseline and after 24 weeks of treatment  
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.
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

Measured Values
    Anastrozole 1 mg     Tamoxifen 20 mg  
Number of Participants Analyzed  
[units: participants]
 		  94     90  
Progesterone Receptor (PgR) Status  
[units: Participants]
 		   
Baseline Positive & 24 weeks Negative     60     19  
Baseline Positive & 24 weeks Positive     29     59  
Baseline Negative & 24 weeks Negative     4     9  
Baseline Negative & 24 weeks Positive     1     3  

No statistical analysis provided for Progesterone Receptor (PgR) Status



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

Measure Type Secondary
Measure Title Human Epidermal Growth Factor Receptor 2 (HER2) Status
Measure Description HER2 status in the ITT population is categorized as Positive or Negative
Time Frame Assessed at baseline and after 24 weeks of treatment  
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.
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

Measured Values
    Anastrozole 1 mg     Tamoxifen 20 mg  
Number of Participants Analyzed  
[units: participants]
 		  94     90  
Human Epidermal Growth Factor Receptor 2 (HER2) Status  
[units: Participants]
 		   
Baseline Positive & 24 weeks Negative     0     0  
Baseline Positive & 24 weeks Positive     0     0  
Baseline Negative & 24 weeks Negative     92     88  
Baseline Negative & 24 weeks Positive     2     2  

No statistical analysis provided for Human Epidermal Growth Factor Receptor 2 (HER2) Status



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

Measure Type Secondary
Measure Title Histopathological Response Rate (HRR)
Measure Description Number of patients in the ITT population defined as histopathological responders over the total number of patients x 100. An histopathological responder = a patient classified as Grade 1b, 2 or 3 for the histopathological response (Grade 0 = no response, 1a = mild response, 1b = moderate response, 2 = marked response or 3 = complete response)
Time Frame Assessed at baseline and after 24 weeks of treatment  
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.
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

Measured Values
    Anastrozole 1 mg     Tamoxifen 20 mg  
Number of Participants Analyzed  
[units: participants]
 		  98     99  
Histopathological Response Rate (HRR)  
[units: Percentage of Participants]
 		  41.8     27.3  

No statistical analysis provided for Histopathological Response Rate (HRR)



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

Measure Type Secondary
Measure Title Functional Assessment of Cancer Therapy-Breast (FACT-B)
Measure Description

Change from baseline in Functional Assessment of Cancer Therapy-Breast (FACT-B)in the ITT population at 24 weeks. Trial Outcome Index (TOI) = the sum of the Physical Well-Being (PWB), Functional Well-Being (FWB), and Breast Cancer Scale (BCS) subscales of FACT-B.

FACT-B includes 36 questions; 7 in PWB (Physical Well-Being); 7 inSWB (Social / Family Well-Being); 6 in EWB (Emotional Well-Being); 7 in FWB (Functional Well-Being); 9 in BCS (Breast Cancer Subscale).

Total score of subscores or TOI is calculated from each score of question. Higher score means better and lower score means worthier.

Score range; 0-28 in PWB; 0-28 in SWB; 0-24 in EWB; 0-28 in FWB; 0-36 in BCS; 0-92 in TOI.
Time Frame Assessed at baseline and after 24 weeks of treatment  
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.

Total score of subscores or TOI is calculated from each score of question. Higher score means better and lower score means worthier.

PWB, FWB and BCS were assessed in this study. TOI was a total of PWB, FWB and BCS.

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]
 		  95     92  
Functional Assessment of Cancer Therapy-Breast (FACT-B)  
[units: Trial Outcome Index (TOI) (Prorated)]
Mean ± Standard Deviation 		  -4.42  ± 11.07     -2.65  ± 8.09  

No statistical analysis provided for Functional Assessment of Cancer Therapy-Breast (FACT-B)



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

Measure Type Secondary
Measure Title Endocrine Subscale (ES)
Measure Description

Change from baseline in Endocrine Symptom Subscale (ES)) in the ITT population at 24 weeks. ES score = the sum of the responses to all the questions on ES, low scores reflect poor quality of life and high scores reflects better quality of life.

Score range: 0-72
Time Frame Assessed at baseline and after 24 weeks of treatment  
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.
Difference of Endocrine Subscale (ES) = ES at 24 weeks – ES at baseline.

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]
 		  92     91  
Endocrine Subscale (ES)  
[units: ES score]
Mean ± Standard Deviation 		  -8.85  ± 8.69     -6.27  ± 8.93  

No statistical analysis provided for Endocrine Subscale (ES)



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

Measure Type Secondary
Measure Title Anastrozole Plasma Concentrations (Cmin)
Measure Description Trough Plasma concentrations (Cmin) of Anastrozole - only Anastrozole arm was evaluated for Trough Plasma concentrations.
Time Frame Assessed at week 12  
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.
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

Measured Values
    Anastrozole 1 mg     Tamoxifen 20 mg  
Number of Participants Analyzed  
[units: participants]
 		  28     0  
Anastrozole Plasma Concentrations (Cmin)  
[units: ng/mL]
Geometric Mean ( Full Range ) 		  29.7  
  ( 17.3 to 52.4 )   		   
   

No statistical analysis provided for Anastrozole Plasma Concentrations (Cmin)




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  Other Adverse Events
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
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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Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided by AstraZeneca

Publications automatically indexed to this study:


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00605267     History of Changes
Other Study ID Numbers: D539BC00001
Study First Received: January 9, 2008
Results First Received: November 26, 2010
Last Updated: August 3, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare