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Anastrozole & ZD1839 Compared With Fulvestrant & ZD1839 in Postmenopausal Women w/ Metastatic Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00057941
First received: April 7, 2003
Last updated: January 9, 2013
Last verified: January 2013
History of Changes
Results First Received: April 11, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: anastrozole
Drug: fulvestrant
Drug: gefitinib

  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
The study opened on September 16, 2003 and closed on May 29, 2007, with final accrual of 148 patients, 74 on each arm. Patients were accrued through ECOG group.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Arm I (Anastrozole and ZD1839) Patients receive oral anastrozole and oral gefitinib once daily on days 1-28.
Arm II (Fulvestrant and ZD1839) Patients receive fulvestrant intramuscularly on day 1 and oral gefitinib once daily on days 1-28.

Participant Flow:   Overall Study
    Arm I (Anastrozole and ZD1839)     Arm II (Fulvestrant and ZD1839)  
STARTED     74     74  
Treated     74     74  
Eligible     72     69  
COMPLETED     0     0  
NOT COMPLETED     74     74  
Death                 1                 2  
Adverse Event                 7                 9  
Lack of Efficacy                 54                 53  
Withdrawal by Subject                 6                 1  
still on treatment                 3                 1  
insurance, symptomatic deterioration                 1                 3  
Ineligible                 2                 5  



  Baseline Characteristics
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Reporting Groups
  Description
Arm I (Anastrozole and ZD1839) Patients receive oral anastrozole and oral gefitinib once daily on days 1-28.
Arm II (Fulvestrant and ZD1839) Patients receive fulvestrant intramuscularly on day 1 and oral gefitinib once daily on days 1-28.
Total Total of all reporting groups

Baseline Measures
    Arm I (Anastrozole and ZD1839)     Arm II (Fulvestrant and ZD1839)     Total  
Number of Participants  
[units: participants]
 		  72     69     141  
Age  
[units: years]
Median ( Full Range ) 		  58  
  ( 34 to 90 )   		  63  
  ( 35 to 91 )   		  59  
  ( 34 to 91 )  
Gender  
[units: participants]
 		     
Female     72     69     141  
Male     0     0     0  
Region of Enrollment  
[units: participants]
 		     
United States     39     39     78  
Peru     33     29     62  
South Africa     0     1     1  



  Outcome Measures

1.  Primary:   Clinical Benefit Rate   [ Time Frame: assessed every 3 cycles while on treatment, assessed every 3 months when follow up <2 years, every 6 months between 2-3 years,no specific requirements after 3 years ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


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: Study Statistician
Organization: Eastern Cooperative Oncology Group (ECOG) Statistical Office
phone: 617-632-3012


No publications provided by National Cancer Institute (NCI)

Publications automatically indexed to this study:


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00057941     History of Changes
Other Study ID Numbers: NCI-2012-03148, U10CA021115, E4101, CDR0000285631
Study First Received: April 7, 2003
Results First Received: April 11, 2011
Last Updated: January 9, 2013
Health Authority: United States: Food and Drug Administration