This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Cetuximab + / - Carboplatin for Estrogen Receptor-Negative, Progesterone Receptor-Negative Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Bristol-Myers Squibb
Avon Foundation
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00232505
First received: October 3, 2005
Last updated: May 25, 2017
Last verified: May 2017
Results First Received: April 7, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Outcomes Assessor;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Biological: cetuximab
Drug: carboplatin

  Participant Flow
  Hide 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 between December 2005 and October 2007 from thirteen cancer centers throughout the US.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Four patients declined participation for personal reasons, three were screen failures, three had death or progression during the screening period.

Reporting Groups
  Description
Cetuximab

Patients receive cetuximab IV over 60-120 minutes once a week. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients not responding to treatment may cross over to arm II.

cetuximab: Given IV

Cetuximab and Carboplatin

Patients receive cetuximab as in arm I and carboplatin IV on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

cetuximab: Given IV

carboplatin: Given IV


Participant Flow:   Overall Study
    Cetuximab   Cetuximab and Carboplatin
STARTED   31   71 
Not Evaluable   0   6 
Early Progressors   2   5 
Off Protocol   5   0 
COMPLETED   26   60 
NOT COMPLETED   5   11 



  Baseline Characteristics
  Hide 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
Cetuximab

Patients receive cetuximab IV over 60-120 minutes once a week. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients not responding to treatment may cross over to arm II.

cetuximab: Given IV

Cetuximab and Carboplatin

Patients receive cetuximab as in arm I and carboplatin IV on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

cetuximab: Given IV

carboplatin: Given IV

Total Total of all reporting groups

Baseline Measures
   Cetuximab   Cetuximab and Carboplatin   Total 
Overall Participants Analyzed 
[Units: Participants]
 31   71   102 
Age 
[Units: Years]
Median (Full Range)
 49 
 (33 to 71) 
 52 
 (28 to 83) 
 50.5 
 (28 to 83) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      31 100.0%      71 100.0%      102 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      1   3.2%      1   1.4%      2   2.0% 
Asian      0   0.0%      2   2.8%      2   2.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      11  35.5%      17  23.9%      28  27.5% 
White      19  61.3%      51  71.8%      70  68.6% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   31   71   102 
Eastern Cooperative Oncology Group (ECOG) Performance Status [1] 
[Units: Participants]
Count of Participants
     
    17  54.8%      37  52.1%      54  52.9% 
    14  45.2%      28  39.4%      42  41.2% 
    0   0.0%      4   5.6%      4   3.9% 
missing      0   0.0%      2   2.8%      2   2.0% 
[1]

A scale from 0-5 to describe a patient's level of functioning in terms of selfcare ability and activity level.

0, Fully active

  1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature
  2. Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
Menopausal Status 
[Units: Participants]
Count of Participants
     
Postmenopausal      21  67.7%      56  78.9%      77  75.5% 
Pre- or perimenopausal      10  32.3%      15  21.1%      25  24.5% 
Dominant metastatic site 
[Units: Participants]
Count of Participants
     
Lung      9  29.0%      20  28.2%      29  28.4% 
Liver      8  25.8%      17  23.9%      25  24.5% 
Lymph nodes      4  12.9%      14  19.7%      18  17.6% 
Locoregional      5  16.1%      10  14.1%      15  14.7% 
Bone      1   3.2%      4   5.6%      5   4.9% 
Skin/soft tissue      3   9.7%      5   7.0%      8   7.8% 
Other      1   3.2%      1   1.4%      2   2.0% 
Treatment 
[Units: Participants]
     
Prior chemotherapy   30   67   97 
Adjuvant/neoadjuvant   26   60   86 
Metastatic   21   34   55 


  Outcome Measures
  Show All Outcome Measures

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

2.  Secondary:   Overall Survival   [ Time Frame: Every four months until death of any cause or end of data collection up to 40 months ]

3.  Secondary:   Progression-Free Survival   [ Time Frame: Every four months until progression, death of any cause, or end of data collection up to 40 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Robin V. Johnson
Organization: UNC Lineberger Comprehensive Cancer Center
phone: 919-966-1125
e-mail: Robin_V_Johnson@med.unc.edu


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

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00232505     History of Changes
Obsolete Identifiers: NCT00420329, NCT00492375
Other Study ID Numbers: LCCC 0403
M01RR000046 ( U.S. NIH Grant/Contract )
CA058223 ( Other Grant/Funding Number: NCI OSP/SPOREs )
Study First Received: October 3, 2005
Results First Received: April 7, 2017
Last Updated: May 25, 2017