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

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic Identifier:
First received: May 3, 2005
Last updated: May 31, 2011
Last verified: May 2011
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
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
STARTED     50  
COMPLETED     22  
Adverse Event                 9  
Death                 1  
Patient Refusal                 10  
Alternate Therapy                 5  
Intercurrent Illness                 1  
Other                 2  

  Baseline Characteristics
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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
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
Number of Participants  
[units: participants]
[units: years]
Median (Full Range)
  (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 ]

2.  Secondary:   Progression-free Survival   [ Time Frame: Time from registration to progression or death (up to 5 years) ]

3.  Secondary:   Overall Survival   [ Time Frame: Death or last follow-up (up to 5 years) ]

4.  Secondary:   Adverse Event   [ Time Frame: Every 6 weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Dr. Vivek Roy
Organization: Mayo Clinic
phone: 507-284-1159

Publications of Results:

Responsible Party: Vivek Roy, M.D., Mayo Clinic Cancer Center Identifier: NCT00110084     History of Changes
Other Study ID Numbers: CDR0000423195
U10CA025224 ( US NIH Grant/Contract Award Number )
N0531 ( Other Identifier: Mayo Clinic Cancer Cancer and NCCTG )
855-05 ( Other Identifier: Mayo Clinic IRB )
N0433 ( Other Identifier: NCCTG Old Protocol )
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