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Neoadjuvant Carboplatin, Weekly Abraxane and Trastuzumab in HER2+ Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00617942
First Posted: February 18, 2008
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Yale University
Information provided by (Responsible Party):
William Sikov, Brown University
Results First Submitted: November 14, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Cohort 1 neo-adjuvant
Drug: Cohort 2 neo-adjuvant
Drug: Cohort 1 adjuvant
Drug: Cohort 2 adjuvant

  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
No text entered.

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
Cohort 1

Cohort 1 neo-adjuvant: Cohort 1 : Trastuzumab 6 mg/kg IV over 60 minutes day -14

Trastuzumab 2 mg/kg IV over 60 minutes weekly then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16

Cohort 1 adjuvant: Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians

Cohort 2

Cohort 2 neo-adjuvant: Cohort 2 :Abraxane 100 mg/m2 IV over 30 minutes days -14 and -7 Trastuzumab 2 mg/kg IV over 60 minutes weekly (4 mg/kg week 1) then Abraxane 100 mg/m2 IV over 30 minutes weekly x 18 weeks followed by Carboplatin at AUC 6 IV over 30 min weeks 1,4,7,10,13 and 16

Cohort 2 adjuvant: Trastuzumab 8 mg/kg x 1 dose, then 6 mg/kg q3wks x 11 doses Adjuvant chemotherapy, post-op radiation and hormonal therapy at discretion of treating physicians


Participant Flow:   Overall Study
    Cohort 1   Cohort 2
STARTED   37   23 
COMPLETED   29   19 
NOT COMPLETED   8   4 



  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.
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Reporting Groups
  Description
Cohort 1 No text entered.
Cohort 2 No text entered.
Total Total of all reporting groups

Baseline Measures
   Cohort 1   Cohort 2   Total 
Overall Participants Analyzed 
[Units: Participants]
 37   23   60 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      34  91.9%      20  87.0%      54  90.0% 
>=65 years      3   8.1%      3  13.0%      6  10.0% 
Age 
[Units: Years]
Mean (Full Range)
 51.4 
 (32 to 72) 
 51.6 
 (35 to 70) 
 51.5 
 (32 to 72) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      37 100.0%      23 100.0%      60 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   37   23   60 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Patients With Complete Pathologic Response Rate, Observed Following Treatment With q3week Carboplatin, Weekly Abraxane and Weekly Trastuzumab in Resectable and Unresectable LABC;   [ Time Frame: 1 year ]

2.  Secondary:   Patients Affected by Toxicities of Regimen During Treatment, Including Grade >2 Neurotoxicity the Incidence of Subclinical and Clinical Cardiac Toxicity   [ Time Frame: 1 year ]


  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
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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.


Results Point of Contact:  
Name/Title: William Sikov, MD
Organization: Brown University Oncology Research Group (BrUOG)
phone: 4018633000
e-mail: kayla_rosati@brown.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: William Sikov, Brown University
ClinicalTrials.gov Identifier: NCT00617942     History of Changes
Other Study ID Numbers: BrUOG-BR-211B
First Submitted: February 6, 2008
First Posted: February 18, 2008
Results First Submitted: November 14, 2015
Results First Posted: August 22, 2017
Last Update Posted: August 22, 2017