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Bevacizumab in Treating Patients With Metastatic Breast Cancer That Overexpresses HER-2/NEU

This study has been terminated.
(Closed early due to slow accrual)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00520975
First received: August 24, 2007
Last updated: October 5, 2016
Last verified: October 2016
Results First Received: October 5, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Breast Carcinoma
Recurrent Breast Carcinoma
Stage IV Breast Cancer
Interventions: Biological: Bevacizumab
Drug: Carboplatin
Drug: Paclitaxel
Other: Placebo
Biological: Trastuzumab

  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
Ninety-six patients were randomized between November 9, 2007 and October 28, 2009 when the trial closed due to slow accrual.

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 A (Chemotherapy and Placebo)

INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Carboplatin: Given IV

Paclitaxel: Given IV

Placebo: Given IV

Trastuzumab: Given IV

Arm B (Chemotherapy and Bevacizumab)

INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Bevacizumab: Given IV

Carboplatin: Given IV

Paclitaxel: Given IV

Trastuzumab: Given IV


Participant Flow:   Overall Study
    Arm A (Chemotherapy and Placebo)   Arm B (Chemotherapy and Bevacizumab)
STARTED   48   48 
COMPLETED   0 [1]   0 [1] 
NOT COMPLETED   48   48 
Disease progression                31                23 
Adverse Event                7                10 
Death                0                2 
Withdrawal by Subject                3                5 
Other therapy                2                4 
Other reasons                4                2 
Not start protocol therapy                1                2 
[1] Treatment continued until progression or intolerable toxicity.



  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.
All randomized patients

Reporting Groups
  Description
Arm A (Chemotherapy and Placebo)

INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Carboplatin: Given IV

Paclitaxel: Given IV

Placebo: Given IV

Trastuzumab: Given IV

Arm B (Chemotherapy and Bevacizumab)

INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.

MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Bevacizumab: Given IV

Carboplatin: Given IV

Paclitaxel: Given IV

Trastuzumab: Given IV

Total Total of all reporting groups

Baseline Measures
   Arm A (Chemotherapy and Placebo)   Arm B (Chemotherapy and Bevacizumab)   Total 
Overall Participants Analyzed 
[Units: Participants]
 48   48   96 
Age 
[Units: Years]
Median (Full Range)
 55 
 (27 to 77) 
 55 
 (33 to 76) 
 55 
 (27 to 77) 
Gender 
[Units: Participants]
     
Female   48   48   96 
Male   0   0   0 


  Outcome Measures
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1.  Primary:   Progression-free Survival   [ Time Frame: assessed every 3 months for patients within 2 years of registration, every 6 months for patients 3-5 years from registration and then yearly for up to10 years ]

2.  Secondary:   Overall Survival   [ Time Frame: assessed every 3 months for patients within 2 years of registration, every 6 months for patients 3-5 years from registration and then yearly for up to10 years ]

3.  Secondary:   Proportion of Progression-free at 6 Months   [ Time Frame: assessed at 3 and 6 months after study entry ]

4.  Secondary:   Overall Response Rate   [ Time Frame: assessed at baseline and every 12 weeks while on treatment ]

5.  Secondary:   Number of Patients Experiencing Congestive Heart Failure   [ Time Frame: assessed every 3 months while on treatment and 3 months post treatment ]

6.  Other Pre-specified:   Change in Fatigue Level Between Baseline and Cycle 6 Induction   [ Time Frame: assessed at baseline and cycle 6 induction prior to starting maintenance therapy ]

7.  Other Pre-specified:   Change in FACT/NCCN Breast Symptom Index (FBSI) Between Baseline and Cycle 6 Induction   [ Time Frame: assessed at baseline and cycle 6 induction prior to starting maintenance therapy ]

8.  Other Pre-specified:   Change in Neurotoxicity Level Between Baseline and Cycle 6 Induction   [ Time Frame: assessed at baseline and cycle 6 induction prior to starting maintenance therapy ]

9.  Other Pre-specified:   Change in Level of Experiencing Side Effects Between Baseline and Cycle 6 Induction   [ Time Frame: assessed at baseline and cycle 6 induction prior to starting maintenance therapy ]

10.  Other Pre-specified:   Number of Circulating Tumor Cells at Baseline   [ Time Frame: assessed at baseline prior to starting protocol therapy ]

11.  Other Pre-specified:   VEGF Levels in Breast Tumor by Immunohistochemistry Assay (Tumor Sample Has Not Been Analyzed Yet, no Results Could be Reported)   [ Time Frame: assessed at baseline ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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: ECOG-ACRIN statistician
Organization: ECOG-ACRIN Statistical Office
phone: 617-632-3012



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00520975     History of Changes
Other Study ID Numbers: NCI-2009-00504
NCI-2009-00504 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
E1105 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
U10CA180794 ( US NIH Grant/Contract Award Number )
U10CA023318 ( US NIH Grant/Contract Award Number )
Study First Received: August 24, 2007
Results First Received: October 5, 2016
Last Updated: October 5, 2016
Health Authority: United States: Food and Drug Administration