Carboplatin, Abraxane, Avastin as Neoadjuvant Therapy for Her2-Negative Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Yale University
Information provided by (Responsible Party):
William Sikov, Brown University
ClinicalTrials.gov Identifier:
NCT00723125
First received: July 15, 2008
Last updated: October 14, 2014
Last verified: October 2014
Results First Received: July 17, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Abraxane
Drug: Carboplatin
Drug: Avastin

  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
DDAC: (dose-dense doxorubicin and cyclophosphamide (DDAC)

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
Cohort 1

Avastin 10 mg/kg IV over 90 minutes day -14 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks

Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)

Cohort 2

Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10) Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles followed by Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks

Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)


Participant Flow:   Overall Study
    Cohort 1     Cohort 2  
STARTED     33 [1]   27 [2]
COMPLETED     15     21  
NOT COMPLETED     18     6  
Met Dx                 1                 0  
Withdrawal by Subject                 15                 6  
Adverse Event                 2                 0  
[1] 33 pts Neo-adjuvant, 28 evaluable,DDAC: Of 28 pts,27 treated DDAC Avastin:Of 27,15 Avastin post-op
[2] 27 evaluable Neo-adjuvant Of 27 patients neo-adjuvant, 24 DDAC Of 24 DDAC, 21 Avastin post-op



  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
Cohort 1

Avastin 10 mg/kg IV over 90 minutes day -14 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 Avastin 10 mg/kg IV over 30-60 minutes cycles 1-3 (omit dose with cycle 4) Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks

Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)

Cohort 2

Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10) Definitive surgery Avastin 10 mg/kg IV over 30-60 minutes and Doxorubicin 60 mg/m2* and Cyclophosphamide 600 mg/m2 IV q2weeks x 4 cycles followed by Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 34 weeks OR Avastin 10 mg/kg IV over 30-60 minutes q2weeks x 42 weeks

Cohort 1 and Cohort 2: Abraxane 100 mg/m2 IV over 30 minutes weekly x 12 weeks with Carboplatin at AUC 6 over 30 min IV and Avastin 15 mg/kg IV over 30-90 minutes weeks 1,4,7, and 10 (in Cohort 2, omit dose of Avastin on week 10)

Total Total of all reporting groups

Baseline Measures
    Cohort 1     Cohort 2     Total  
Number of Participants  
[units: participants]
  33     27     60  
Age  
[units: years]
Mean ( Full Range )
  47.6  
  ( 25 to 68 )  
  45.8  
  ( 28 to 63 )  
  46.8  
  ( 25 to 68 )  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     32     27     59  
>=65 years     1     0     1  
Gender, Customized  
[units: participants]
     
Female     33     27     60  
Region of Enrollment  
[units: participants]
     
United States     33     27     60  



  Outcome Measures

1.  Primary:   Pathological Complete Response Rates at Surgery   [ Time Frame: at surgery approximately 5 months after initial treatment ]

2.  Secondary:   Measure of Safety and Tolerability According to CTC Version 3.0   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  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 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.


Results Point of Contact:  
Name/Title: William Sikov, MD
Organization: BrUOG
phone: 4018633000
e-mail: kayla_rosati@brown.edu


No publications provided


Responsible Party: William Sikov, Brown University
ClinicalTrials.gov Identifier: NCT00723125     History of Changes
Other Study ID Numbers: BrUOG-BR-211A
Study First Received: July 15, 2008
Results First Received: July 17, 2014
Last Updated: October 14, 2014
Health Authority: United States: Institutional Review Board