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

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ClinicalTrials.gov Identifier: NCT00605267
Recruitment Status : Completed
First Posted : January 31, 2008
Results First Posted : September 6, 2012
Last Update Posted : September 6, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Tamoxifen
Drug: Anastrazole (Arimidex)
Drug: Goserelin acetate (Zoladex)

  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

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 
Overall Participants Analyzed 
[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

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  

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 
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


  Other Adverse Events


  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