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Neoadjuvant Biweekly Treatment Followed by Weekly Treatment of Breast Cancer

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ClinicalTrials.gov Identifier: NCT00256243
Recruitment Status : Completed
First Posted : November 21, 2005
Results First Posted : March 17, 2014
Last Update Posted : March 2, 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: Paclitaxel
Drug: Carboplatin
Drug: GM-CSF
Drug: Trastuzumab
Enrollment 48
Recruitment Details Subjects recruited At University of California Irvine Medical Center (UCIMC) are recruited by referral for UCIMC inpatients or outpatients.
Pre-assignment Details  
Arm/Group Title Chemotherapy With GM-CSF
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 48
Completed 38
Not Completed 10
Reason Not Completed
Lost to Follow-up             2
Death             7
Not treated             1
Arm/Group Title Chemotherapy With GM-CSF
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
<=18 years
0
   0.0%
Between 18 and 65 years
47
  97.9%
>=65 years
1
   2.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants
50.29  (11.08)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
Female
48
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Clinical Response Rate
Hide Description Clinical response (CR): Normal breast on physical exam. No mass, no thickening, no erythema, no peau d’orange.
Time Frame 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of the 48 study participants, one patient refused preoperative but received standard adjuvant AC followed by docetaxel (without trastuzumab), relapsed, and died. Therefore, 47 participants were analyzed.
Arm/Group Title Chemotherapy With GM-CSF
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 47
Measure Type: Count of Participants
Unit of Measure: Participants
47
 100.0%
2.Secondary Outcome
Title Microscopic Pathological Response Rate
Hide Description pathological response rate: No evidence of microscopic invasive tumor at the primary tumor site in the surgical specimen.
Time Frame 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of the 48 study participants, one patient refused preoperative but received standard adjuvant AC followed by docetaxel (without trastuzumab), relapsed, and died. Therefore, 47 participants were analyzed.
Arm/Group Title Chemotherapy With GM-CSF
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 47
Measure Type: Count of Participants
Unit of Measure: Participants
47
 100.0%
Time Frame After off treatment, follow-up assessments were done every 6 months for one year. After one year, patients were followed annually for 4 more years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Chemotherapy With GM-CSF
Hide Arm/Group Description

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.

All-Cause Mortality
Chemotherapy With GM-CSF
Affected / at Risk (%)
Total   10/38 (26.32%) 
Show Serious Adverse Events Hide Serious Adverse Events
Chemotherapy With GM-CSF
Affected / at Risk (%)
Total   0/38 (0.00%) 
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 (%)
Total   0/38 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Rita Mehta
Organization: Chao Family Comprehensive Cancer Center
Phone: (714) 456-5153
Responsible Party: Rita Sanghvi, Mehta, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00256243     History of Changes
Other Study ID Numbers: UCI 03-70
2004-3517 ( Other Identifier: University of California, Irvine )
First Submitted: November 17, 2005
First Posted: November 21, 2005
Results First Submitted: August 28, 2009
Results First Posted: March 17, 2014
Last Update Posted: March 2, 2018