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Phase II Trial Comparing ABI-007 (Abraxane®, Nab®-Paclitaxel) to Taxotere in First Line Therapy of Patients With Stage IV Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celgene ( Celgene Corporation )
ClinicalTrials.gov Identifier:
NCT00274456
First received: January 10, 2006
Last updated: July 15, 2013
Last verified: July 2013
Results First Received: February 7, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Metastatic Breast Cancer
Interventions: Drug: ABI-007
Drug: Docetaxel

  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
Three hundred and two patients were enrolled and randomized between November 2005 and June 2006, of which 300 received study drug and were evaluated for response and safety. Data below represents data cut-off 31 March 2008.

Reporting Groups
  Description
ABI-007 300 mg/m^2 q3w ABI-007 300 mg/m^2 administered once every third week (q3w).
ABI-007 100 mg/m^2 Weekly ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
ABI-007 150 mg/m^2 Weekly ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
Docetaxel 100 mg/m^2 q3w Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).

Participant Flow:   Overall Study
    ABI-007 300 mg/m^2 q3w   ABI-007 100 mg/m^2 Weekly   ABI-007 150 mg/m^2 Weekly   Docetaxel 100 mg/m^2 q3w
STARTED   76   76   74   74 
At Least One Response Assessment   73   76   73   70 
COMPLETED   39 [1]   49 [1]   39 [1]   29 [1] 
NOT COMPLETED   37   27   35   45 
Still on treatment                2                3                5                1 
Unacceptable toxicity                10                5                12                16 
Adverse Event                0                1                2                2 
Physician Decision                7                5                6                13 
Lost to Follow-up                0                0                1                0 
Withdrawal by Subject                18                13                9                13 
[1] Treatment completed upon progressive disease



  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
  Description
ABI-007 300 mg/m^2 q3w ABI-007 300 mg/m^2 administered once every third week (q3w).
ABI-007 100 mg/m^2 Weekly ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
ABI-007 150 mg/m^2 ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest.
Docetaxel 100 mg/m^2 q3w Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
Total Total of all reporting groups

Baseline Measures
   ABI-007 300 mg/m^2 q3w   ABI-007 100 mg/m^2 Weekly   ABI-007 150 mg/m^2   Docetaxel 100 mg/m^2 q3w   Total 
Overall Participants Analyzed 
[Units: Participants]
 76   76   74   74   300 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.7  (9.47)   55.4  (9.59)   53.3  (9.14)   55.4  (11.57)   53.9  (10.05) 
Age, Customized 
[Units: Participants]
         
>=65 years   9   14   10   19   52 
<65 years   67   62   64   55   248 
Gender 
[Units: Participants]
         
Female   76   76   74   74   300 
Male   0   0   0   0   0 
Race/Ethnicity, Customized 
[Units: Participants]
         
White, Non-Hispanic, Non-Latino   74   75   74   74   297 
White, Hispanic or Latino   2   1   0   0   3 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 72.56  (12.668)   73.64  (14.670)   76.24  (13.437)   75.99  (14.034)   74.59  (13.742) 
Eastern Cooperative Oncology Group (ECOG) Performance Status [1] 
[Units: Participants]
         
0 (fully active)   34   33   24   28   119 
1 (restrictive but ambulatory)   35   39   45   44   163 
2 (ambulatory but unable to work)   7   4   5   2   18 
3 (limited self-care) + 4 (completely disabled)   0   0   0   0   0 
[1] A scale used to assess the progress of disease in a patient, how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis.
Menopausal Status 
[Units: Participants]
         
Pre-menopausal   26   14   21   12   73 
Post-menopausal   49   62   53   60   224 
Unknown   1   0   0   2   3 
Physician Assessment of Sensory Neuropathy [1] 
[Units: Participants]
         
Grade 0   67   70   65   67   269 
Grade 1   9   6   9   7   31 
[1] The physician assessed sensory neuropathy using the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) of “Neurology -- Neuropathy – Sensory”. The scale is 0=normal and 1=asymptomatic; loss of deep tendon reflexes or paresthesia (including tingling) but not interfering with function.
Time from Primary Diagnosis and from First Metastasis/Relapse to Study Entry 
[Units: Years]
Median (Full Range)
         
Time from Primary Diagnosis to Study Entry   1.24 
 (0.0 to 11.9) 
 1.17 
 (0.0 to 14.9) 
 0.97 
 (0.0 to 16.9) 
 1.27 
 (0.0 to 14.3) 
 1.23 
 (0.0 to 16.9) 
Time from First Metastasis/Relapse to Study Entry   0.02 
 (0.0 to 8.2) 
 0.04 
 (0.0 to 8.1) 
 0.05 
 (0.0 to 2.0) 
 0.04 
 (0.0 to 2.6) 
 0.04 
 (0.0 to 8.2) 
Current Site of Metastasis/Relapse [1] 
[Units: Participants]
         
Breast   10   10   11   11   42 
Skin/Soft Tissue   16   18   15   19   68 
Supraclavicular   23   25   20   25   93 
Axilla   43   48   47   44   182 
Lung/Thoracic   53   49   51   58   211 
Hepatic/Liver   21   28   23   25   97 
Abdomen/Peritoneal   12   11   4   7   34 
Pelvis   0   1   2   1   4 
Bone   22   25   33   25   105 
Other   1   4   1   1   7 
[1] Patients may have multiple sites of metastasis/relapse.
Dominant Current Site of Metastasis/Relapse 
[Units: Participants]
         
Visceral   64   61   59   67   251 
Non-visceral   12   15   15   7   49 
Stage at Primary Diagnosis [1] 
[Units: Participants]
         
Stage I   2   4   3   2   11 
Stage IIa   11   13   11   13   48 
Stage IIb   12   7   13   15   47 
Stage IIIa   11   10   7   6   34 
Stage IIIb   14   14   9   13   50 
Stage IIIc   0   2   0   1   3 
Stage IV   23   25   28   21   97 
Unknown   3   1   3   3   10 
[1]

Invasive breast cancer stages:

  • Stage I-cancer cells are breaking through to or invading normal surrounding breast tissue.
  • Stage IIa-breast tumor about 2cm and involvement of ancillary lymph nodes.
  • Stage IIb-a larger tumor than earlier phases.
  • Stage IIIa-axillary lymph nodes clumping together.
  • Stage IIIb-spread further to the skin, breast bone or chest wall.
  • Stage IIIc-expanded involvement of lymph nodes.
  • Stage IV-cancer that has spread beyond the breast and nearby lymph nodes to other organs of the body.
Number of Lesions (Target + Non-Target) [1] 
[Units: Participants]
         
0 lesions   0   0   0   0   0 
1 lesion   2   1   1   4   8 
2-3 lesions   11   13   6   10   40 
>3 lesions   63   62   67   60   252 
[1] Target lesions were selected on the basis of their size (those with the longest diameter) and their suitability for accurate repeat measurements (either by imaging techniques or clinically).


  Outcome Measures
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1.  Primary:   Percentage of Participants Showing an Overall Response As Assessed by the Independent Radiology Reader and by the Investigator   [ Time Frame: Day 1 up to 95 weeks ]

2.  Secondary:   Percentage of Participants With Stable Disease for ≥ 16 Weeks, or Complete or Partial Overall Response   [ Time Frame: Day 1 up to 95 weeks ]

3.  Secondary:   Kaplan-Meier Estimates for Progression-free Survival (PFS)   [ Time Frame: Day 1 up to 95 weeks ]

4.  Secondary:   Kaplan-Meier Estimates for Duration of Response Based on Independent Radiology Assessment of Response and Progression   [ Time Frame: Day 1 - 95 weeks ]

5.  Secondary:   Kaplan-Meier Estimates for Duration of Response Based on Investigator Assessment of Response and Progression   [ Time Frame: Day 1 - 95 weeks ]

6.  Secondary:   Kaplan-Meier Estimate for Overall Survival (OS)   [ Time Frame: Day 1 to 221 weeks ]

7.  Secondary:   Participants With Treatment-Emergent, Treatment-Related Adverse Events   [ Time Frame: Day 1 up to 125 weeks ]

8.  Other Pre-specified:   Nadir of Myelosuppression (Over All Cycles) as Measured by Absolute Neutrophils (ANC), White Blood Cells (WBC) and Platelet Counts   [ Time Frame: Day 1 up to 125 weeks ]

9.  Other Pre-specified:   Nadir of Myelosuppression (Over All Cycles) as Measured by Hemoglobin (Hb) Counts   [ Time Frame: Day 1 up to 125 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
No text entered.


  More Information
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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: Associate Director, Clinical Trials Disclosure
Organization: Celgene Corporation
phone: 1-888-260-1599
e-mail: clinicaltrialdisclosure@celgene.com


Publications of Results:

Responsible Party: Celgene ( Celgene Corporation )
ClinicalTrials.gov Identifier: NCT00274456     History of Changes
Other Study ID Numbers: CA024
Study First Received: January 10, 2006
Results First Received: February 7, 2011
Last Updated: July 15, 2013
Health Authority: United States: Food and Drug Administration
Ukraine: Ministry of Health