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Neoadjuvant Treatment of Breast Cancer

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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
Enrollment 43
Recruitment Details Subjects were recruited at UCIMC by the following methods: referral for University of California Irvine Medical Center (UCIMC) inpatients or outpatients.
Pre-assignment Details  
Arm/Group Title Chemotherapy With GM-CSF
Hide Arm/Group Description Doxorubicin and Cyclophosphamide (AC) with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) Followed by Weekly Carboplatin/Nab- Paclitaxel
Period Title: Overall Study
Started 43
Completed 41
Not Completed 2
Arm/Group Title Chemotherapy With GM-CSF
Hide Arm/Group Description Doxorubicin and Cyclophosphamide (AC) with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) Followed by Weekly Carboplatin/Nab- Paclitaxel
Overall Number of Baseline Participants 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants
<=18 years
0
   0.0%
Between 18 and 65 years
36
  83.7%
>=65 years
7
  16.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants
52  (12.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants
Female
43
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 43 participants
43
1.Primary Outcome
Title Overall Clinical Response to the Dose Dense Regimen
Hide Description Measure clinical response rates in patients with breast cancer more than 2 cm and/or lymph node positive breast cancer treated with 2- 4 cycles of biweekly doxorubicin, cyclophosphamide with GMCSF (day 4-13) followed by weekly carboplatin/nab-paclitaxel given for 3 weeks, followed by 1 week of rest, for a total of 9-12 doses. (Her-2 positive patients, in addition, will receive Trastuzumab weekly (12-16 doses) and Her-2 negative patients will receive Bevacizumab (6-8 doses) q 2 weeks).
Time Frame 3 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chemotherapy With GM-CSF
Hide Arm/Group Description:
Doxorubicin and Cyclophosphamide (AC) with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) Followed by Weekly Carboplatin/Nab- Paclitaxel
Overall Number of Participants Analyzed 43
Measure Type: Count of Participants
Unit of Measure: Participants
43
 100.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Chemotherapy With GM-CSF
Hide Arm/Group Description Doxorubicin and Cyclophosphamide (AC) with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) Followed by Weekly Carboplatin/Nab- Paclitaxel
All-Cause Mortality
Chemotherapy With GM-CSF
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Chemotherapy With GM-CSF
Affected / at Risk (%) # Events
Total   4/43 (9.30%)    
Cardiac disorders   
Cardio Vascular Disease *  1/43 (2.33%)  1
Immune system disorders   
Neutropenic fever   3/43 (6.98%)  3
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Chemotherapy With GM-CSF
Affected / at Risk (%) # Events
Total   0/43 (0.00%)    
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
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