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Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Gemcitabine, and Bevacizumab in Treating Patients With Metastatic Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00662129
First Posted: April 21, 2008
Last Update Posted: April 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
Results First Submitted: January 13, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Biological: bevacizumab
Drug: gemcitabine hydrochloride
Drug: paclitaxel albumin-stabilized nanoparticle formulation

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Paclitaxel + Gemcitabine + Bevacizumab Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Paclitaxel + Gemcitabine + Bevacizumab
STARTED   50 
COMPLETED   47 
NOT COMPLETED   3 
Protocol Violation                1 
Cancel prior to beginning treatment                1 
Ineligible                1 



  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.
One patient had a major violation (sequence of drugs was incorrect on Day 8 of Cycle 1), one patient canceled treatment prior to beginning treatment, and one patient was ineligible. The ineligible patient was included in the final analysis, whereas the two patients were excluded.

Reporting Groups
  Description
Paclitaxel + Gemcitabine + Bevacizumab Patients receive 125 mg/m^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Baseline Measures
   Paclitaxel + Gemcitabine + Bevacizumab 
Overall Participants Analyzed 
[Units: Participants]
 48 
Age 
[Units: Years]
Median (Full Range)
 55.5 
 (27.0 to 77.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      48 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   48 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   6-month Progression-free Survival (PFS) Rate   [ Time Frame: at 6 months ]

2.  Secondary:   Overall Survival Time   [ Time Frame: Up to 5 years ]

3.  Secondary:   PFS Time   [ Time Frame: Up to 5 years ]

4.  Secondary:   Confirmed Response (Complete or Partial Response) Rate   [ Time Frame: Up to 5 years ]

5.  Secondary:   Duration of Response   [ Time Frame: Up to 5 years ]

6.  Secondary:   Time to Treatment Failure   [ Time Frame: Up to 5 years ]

7.  Secondary:   Quality of Life, as Measure by the Mean Change in FACT-B TOI Score at Cycle 8   [ Time Frame: From baseline to end of Cycle 8; Up to 24 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: Donald W. Northfelt, MD, FACP
Organization: Mayo Clinic
phone: 507/284-1159
e-mail: northfelt.donald@mayo.edu


Publications of Results:
Northfelt DW, Dueck AC, Flynn TP, et al.: Phase II trial combining nab-paclitaxel (NP), gemcitabine (G), and bevacizumab (B) in patients (pts) with metastatic breast cancer (MBC): NCCTG N0735. [Abstract] J Clin Oncol 29 (Suppl 15): A-1126, 2011.


Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00662129     History of Changes
Other Study ID Numbers: NCCTG-N0735
NCI-2009-00666 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000593581 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: April 18, 2008
First Posted: April 21, 2008
Results First Submitted: January 13, 2017
Results First Posted: April 17, 2017
Last Update Posted: April 17, 2017