Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Tamoxifen Citrate or Letrozole With or Without Bevacizumab in Treating Women With Stage III or Stage IV Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00601900
First received: January 18, 2008
Last updated: July 13, 2016
Last verified: July 2016
Results First Received: May 16, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Estrogen Receptor Positive
Progesterone Receptor Positive
Recurrent Breast Carcinoma
Stage IIIB Breast Cancer
Stage IV Breast Cancer
Interventions: Biological: Bevacizumab
Other: Laboratory Biomarker Analysis
Drug: Letrozole
Other: Questionnaire Administration
Drug: Tamoxifen Citrate

  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
No text entered.

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 (Endocrine Therapy With Monoclonal Antibody) Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Arm II (Endocrine Therapy) Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Arm I (Endocrine Therapy With Monoclonal Antibody)     Arm II (Endocrine Therapy)  
STARTED     195     199  
COMPLETED     195     196  
NOT COMPLETED     0     3  
Withdrawal by Subject                 0                 3  



  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
Arm I (Endocrine Therapy With Monoclonal Antibody) Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Arm II (Endocrine Therapy) Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Total Total of all reporting groups

Baseline Measures
    Arm I (Endocrine Therapy With Monoclonal Antibody)     Arm II (Endocrine Therapy)     Total  
Number of Participants  
[units: participants]
  195     196     391  
Age  
[units: years]
Median (Full Range)
  55.5  
  (24.7 to 85.3)  
  58.9  
  (29.0 to 87)  
  57.7  
  (24.7 to 87)  
Gender  
[units: participants]
     
Female     195     196     391  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     195     196     391  
Endocrine Therapy Elected  
[units: participants]
     
Letrozole     174     174     348  
Tamoxifen     21     22     43  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival   [ Time Frame: From randomization until disease progression or death whichever occurs first, assessed up to 5 years ]

2.  Secondary:   12 Month Progression Free Survival Rate   [ Time Frame: At 12 months ]

3.  Secondary:   6 Month Progression-Free Survival Rate   [ Time Frame: At 6 months ]

4.  Secondary:   Objective Response Rate   [ Time Frame: Assessed up to 5 years ]

5.  Secondary:   Overall Survival (OS)   [ Time Frame: Assessed up to 5 years ]

6.  Secondary:   Duration of Tumor Response   [ Time Frame: From the time measurement criteria are met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Probability of Surviving Until 36 Months   [ Time Frame: At 36 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Site of Progression   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Time-to-treatment Failure   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Treatment Related Toxicity   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  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
  Hide More Information

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: Maura Dickler, M.D.
Organization: Memorial Sloan-Kettering Cancer Center
e-mail: dicklerm@mskcc.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00601900     History of Changes
Other Study ID Numbers: NCI-2009-00477
NCI-2009-00477 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CALGB 40503/CTSU 40503
CDR0000584091
CALGB 40503 ( Other Identifier: Alliance for Clinical Trials in Oncology )
CALGB-40503 ( Other Identifier: CTEP )
U10CA180821 ( US NIH Grant/Contract Award Number )
U10CA031946 ( US NIH Grant/Contract Award Number )
Study First Received: January 18, 2008
Results First Received: May 16, 2016
Last Updated: July 13, 2016
Health Authority: United States: Food and Drug Administration