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Trial record 47 of 254 for:    inflammatory breast cancer

Neoadjuvant Treatment of Breast Cancer

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.
ClinicalTrials.gov Identifier: NCT00254592
Recruitment Status : Active, not recruiting
First Posted : November 16, 2005
Results First Posted : November 11, 2013
Last Update Posted : February 9, 2018
Sponsor:
Information provided by (Responsible Party):
Rita Sanghvi, Mehta, University of California, Irvine

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Doxorubicin
Drug: Cyclophosphamide
Drug: Carboplatin
Drug: Nab-paclitaxel
Drug: GM-CSF
Drug: Trastuzumab
Drug: Bevacizumab

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited at UCIMC by the following methods: referral for University of California Irvine Medical Center (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) with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) Followed by Weekly Carboplatin/Nab- Paclitaxel

Participant Flow:   Overall Study
    Chemotherapy With GM-CSF
STARTED   43 
COMPLETED   41 
NOT COMPLETED   2 



  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
Chemotherapy With GM-CSF Doxorubicin and Cyclophosphamide (AC) with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) Followed by Weekly Carboplatin/Nab- Paclitaxel

Baseline Measures
   Chemotherapy With GM-CSF 
Overall Participants Analyzed 
[Units: Participants]
 43 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      36  83.7% 
>=65 years      7  16.3% 
Age 
[Units: Years]
Mean (Standard Deviation)
 52  (12.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      43 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   43 


  Outcome Measures

1.  Primary:   Overall Clinical Response to the Dose Dense Regimen   [ Time Frame: 3 years ]


  Serious Adverse Events


  Other Adverse Events


  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

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: Rita S. MEHTA, MD
Organization: University of California Irvine Medical Center
phone: (714) 456-5153
e-mail: rsmehta@uci.edu



Responsible Party: Rita Sanghvi, Mehta, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00254592     History of Changes
Other Study ID Numbers: UCI 05-38
2005-4550 ( Other Identifier: University of California, Irvine )
First Submitted: November 15, 2005
First Posted: November 16, 2005
Results First Submitted: August 28, 2009
Results First Posted: November 11, 2013
Last Update Posted: February 9, 2018