Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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

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
  Show All Outcome Measures

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

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

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

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

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

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

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

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

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

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

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

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 ]
  Show Outcome Measure 12

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

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

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

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

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


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Show More Information