Neoadjuvant Biweekly Treatment Followed by Weekly Treatment of Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chao Family Comprehensive Cancer Center, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00256243
First received: November 17, 2005
Last updated: January 28, 2014
Last verified: January 2014
Results First Received: August 28, 2009  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Inflammatory Breast Cancer
Locally Advanced Breast Cancer
Interventions: Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Paclitaxel
Drug: Carboplatin
Drug: GM-CSF
Drug: 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
Subjects recruited At University of California Irvine Medical Center (UCIMC) are recruited by referral for UCIMC inpatients or outpatients.

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
Chemotherapy With GM-CSF

Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (day 2-6)

This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour.


Participant Flow:   Overall Study
    Chemotherapy With GM-CSF  
STARTED     48  
COMPLETED     38  
NOT COMPLETED     10  
Lost to Follow-up                 2  
Death                 7  
Not treated                 1  



  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
Chemotherapy With GM-CSF

Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with GM-CSF (day 2-6)

This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour.


Baseline Measures
    Chemotherapy With GM-CSF  
Number of Participants  
[units: participants]
  48  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     47  
>=65 years     1  
Age  
[units: years]
Mean ± Standard Deviation
  50.29  ± 11.08  
Gender  
[units: participants]
 
Female     48  
Male     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Clinical Response Rate   [ Time Frame: 5 years ]

2.  Secondary:   Microscopic Pathological Response Rate   [ Time Frame: 5 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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Nicole Macaranas, Clinical Research Specialist
Organization: Chao Family Comprehensive Cancer Center
phone: (714) 456-6550
e-mail: nicole.macaranas@uci.edu


No publications provided


Responsible Party: Chao Family Comprehensive Cancer Center, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00256243     History of Changes
Other Study ID Numbers: UCI 03-70, 2004-3517
Study First Received: November 17, 2005
Results First Received: August 28, 2009
Last Updated: January 28, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration