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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00057941
First received: April 7, 2003
Last updated: April 22, 2014
Last verified: January 2013
Results First Received: April 11, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Estrogen Receptor-positive Breast Cancer
Progesterone Receptor-positive Breast Cancer
Recurrent Breast Cancer
Stage IV Breast Cancer
Interventions: Drug: anastrozole
Drug: gefitinib
Drug: fulvestrant
Other: laboratory biomarker analysis

  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
No text entered.

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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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
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 ]


  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
No text entered.


  More Information
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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.


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, NCI-2012-03148, CDR0000285631, U10CA021115, E4101, E4101, U10CA021115
Study First Received: April 7, 2003
Results First Received: April 11, 2011
Last Updated: April 22, 2014
Health Authority: United States: Food and Drug Administration