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ABI-007 (Nab-Paclitaxel) and Gemcitabine in Treating Women With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00110084
First received: May 3, 2005
Last updated: May 31, 2011
Last verified: May 2011
History of Changes
Results First Received: March 29, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Gemcitabine
Drug: Paclitaxel protein-bound particles for injectable suspension (albumin-bound)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from 22 medical clinics in the United States between November 2005 to May 2006

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
Nab-paclitaxel/Gemcitabine Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle

Participant Flow:   Overall Study
    Nab-paclitaxel/Gemcitabine  
STARTED     50  
COMPLETED     22  
NOT COMPLETED     28  
Adverse Event                 9  
Death                 1  
Patient Refusal                 10  
Alternate Therapy                 5  
Intercurrent Illness                 1  
Other                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Nab-paclitaxel/Gemcitabine Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle

Baseline Measures
    Nab-paclitaxel/Gemcitabine  
Number of Participants  
[units: participants]
 		  50  
Age  
[units: years]
Median ( Full Range ) 		  56  
  ( 29 to 86 )  
Gender, Customized  
[units: participants]
 		 
Female     50  
Region of Enrollment  
[units: participants]
 		 
United States     50  
Dominant disease site  
[units: participants]
 		 
Soft tissue     5  
Osseous     4  
Visceral     41  
Estrogen receptor status [1]
[units: participants]
 		 
Positive     34  
Negative     14  
Unknown     2  
HER2 (human epidermal growth factor receptor 2) status  
[units: participants]
 		 
Positive     1  
Negative     49  
Number of metastatic sites  
[units: participants]
 		 
1     5  
2     15  
3+     30  
Performance Score [2]
[units: participants]
 		 
0 - Fully Active     23  
1 - Ambulatory, restricted strenuous activity     27  
Progesterone receptor status [1]
[units: participants]
 		 
Positive     28  
Negative     20  
Unknown     2  
[1] Using IHC (Immunohistochemistry): categorization is determined by individual institution standards.
[2] Classifies patients according to their functional impairment. Scores range from 0 (fully active) to 5 (death).



  Outcome Measures
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1.  Primary:   Proportion of Patients With Confirmed Responses   [ Time Frame: Two consecutive evaluations at least 6 weeks apart ]
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2.  Secondary:   Progression-free Survival   [ Time Frame: Time from registration to progression or death (up to 5 years) ]
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3.  Secondary:   Overall Survival   [ Time Frame: Death or last follow-up (up to 5 years) ]
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4.  Secondary:   Adverse Event   [ Time Frame: Every 6 weeks ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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.  


Results Point of Contact:  
Name/Title: Dr. Vivek Roy
Organization: Mayo Clinic
phone: 507-284-1159
e-mail: roy.vivek@mayo.edu


Publications of Results:
Roy V, LaPlant BR, Gross GG, et al.: NCCTG phase II trial N0531of weekly nab-paclitaxel (nab-p) in combination with gemcitabine (gem) in patients with metastatic breast cancer (MBC). [Abstract] J Clin Oncol 25 (Suppl 18): A-1048, 2007.


Responsible Party: Vivek Roy, M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00110084     History of Changes
Other Study ID Numbers: CDR0000423195, U10CA025224, N0531, 855-05, N0433
Study First Received: May 3, 2005
Results First Received: March 29, 2011
Last Updated: May 31, 2011
Health Authority: United States: Food and Drug Administration