Panitumumab, Gemcitabine and Carboplatin in Triple-Negative Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
Amgen
Eli Lilly and Company
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00894504
First received: May 5, 2009
Last updated: April 28, 2015
Last verified: April 2015
Results First Received: November 21, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Metastatic Breast Cancer
Interventions: Drug: Panitumumab
Drug: Carboplatin
Drug: Gemcitabine

  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
No text entered.

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
Panitumumab/Gemcitabine/Carboplatin

Treatment cycles are repeated every 14 days (2 weeks)

Panitumumab: 6mg/kg intravenous (IV), Day 1 of each 2-week treatment cycle.

Gemcitabine: 1500mg/m2 IV, Day 1 of each 2-week treatment cycle

Carboplatin: Area Under the Curve (AUC) = 2.5 IV, Day 1 of each 2-week treatment cycle


Participant Flow:   Overall Study
    Panitumumab/Gemcitabine/Carboplatin  
STARTED     71  
COMPLETED     0  
NOT COMPLETED     71  



  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
Panitumumab/Gemcitabine/Carboplatin Panitumumab - 6 mg/kg IV on Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks) Carboplatin - AUC=2.5 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks) Gemcitabine - 1500 mg/m2 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks)

Baseline Measures
    Panitumumab/Gemcitabine/Carboplatin  
Number of Participants  
[units: participants]
  71  
Age  
[units: Years]
Median (Full Range)
  54   (32 to 85)  
Gender  
[units: participants]
 
Female     71  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     71  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: every 6 weeks until treatment discontinuation ]

2.  Secondary:   Objective Response Rate and Clinical Benefit Rate   [ Time Frame: every 6 weeks until treatment discontinuation ]

3.  Secondary:   Number of Treatment-related Toxicities Occurring in ≥10% of Patients as a Measure of Tolerability and Toxicity   [ Time Frame: every 6 weeks until discontinuation of treatment, expected average of 18 months ]

4.  Secondary:   Correlation of Biomarker Expressions of EGFR, K-ras, p53, PTEN Expression, and PI3K in Triple-negative Breast Cancer With Response to Treatment With the Combination of Gemcitabine, Carboplatin, and Panitumumab   [ Time Frame: 18 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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: John D. Hainsworth, MD
Organization: Sarah Cannon Research Institute
phone: 1-877-691-7274
e-mail: asksarah@scresearch.net


No publications provided


Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00894504     History of Changes
Other Study ID Numbers: SCRI BRE 126
Study First Received: May 5, 2009
Results First Received: November 21, 2014
Last Updated: April 28, 2015
Health Authority: United States: Food and Drug Administration