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Study of Albumin-bound Paclitaxel (Abraxane) in Combination With Carboplatin and Herceptin in Patients With Advanced Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00093145
First Posted: October 5, 2004
Last Update Posted: July 17, 2013
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.
Information provided by (Responsible Party):
Celgene ( Celgene Corporation )
Results First Submitted: May 7, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Albumin-bound paclitaxel
Drug: Carboplatin
Drug: Herceptin®

  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
Due to slow patient accrual, only 32 patients of the planned 50 patients were enrolled. Patients were enrolled between June 2004 and July 2007.

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
Albumin-bound Paclitaxel, Carboplatin + Herceptin Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.

Participant Flow:   Overall Study
    Albumin-bound Paclitaxel, Carboplatin + Herceptin
STARTED   32 
At Least One Response Assessment   31 
COMPLETED   15 [1] 
NOT COMPLETED   17 
Unacceptable Toxicity Only                2 
Physician Decision                5 
Withdrawal by Subject                9 
Other                1 
[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
Albumin-bound Paclitaxel, Carboplatin + Herceptin Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.

Baseline Measures
   Albumin-bound Paclitaxel, Carboplatin + Herceptin 
Overall Participants Analyzed 
[Units: Participants]
 32 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   29 
>=65 years   3 
Age 
[Units: Years]
Median (Full Range)
 52.0 
 (29 to 76) 
Gender 
[Units: Participants]
 
Female   32 
Male   0 
Race/Ethnicity, Customized 
[Units: Participants]
 
Black, of African Heritage   4 
White, Non-Hispanic and Non-Latino   26 
White, Hispanic or Latino   2 
Region of Enrollment 
[Units: Participants]
 
United States   32 
Menopausal Status 
[Units: Participants]
 
Pre-Menopausal   7 
Post-Menopausal   25 
Eastern Cooperative Oncology Group (ECOG) Performance Status [1] 
[Units: Participants]
 
0 (Fully Active)   19 
1 (Restrictive but Ambulatory)   12 
2 (Ambulatory, but Unable to Work)   1 
[1]

A scale used to assess the progress of disease, how the disease affects the daily living abilities of the patient, and to determine appropriate treatment and prognosis.

0=Fully active, able to perform all pre-disease activity. 1=Restricted in physically strenuous activity, ambulatory, able to perform light work. 2=Ambulatory, capable of all selfcare, unable to carry out any work activities. Up and about >50% of waking hours. 3=Capable of limited selfcare, confined to bed or chair >50% of waking hours. 4=Completely disabled. Cannot perform any selfcare. Confined to bed or chair. 5=Dead.

Physician assessment of peripheral neuropathy [1] 
[Units: Participants]
 
Grade 0   30 
Grade 1   1 
[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. Data available for 31 participants.
Histology of Primary Diagnosis 
[Units: Participants]
 
Carcinoma/Adenocarcinoma   31 
Other   1 
Time from first documented metastatic disease to study entry 
[Units: Years]
Median (Full Range)
 0.1 
 (0 to 6) 
Specific site(s) of metastasis/relapse [1] 
[Units: Participants]
 
Brain/Central Nervous System   1 
Skin/Soft Tissue/Breast   21 
Lymph Nodes   24 
Lung   19 
Liver   15 
Peritoneal   1 
Bone   22 
Other   1 
[1] Participants can be in multiple sites of metastasis/relapse categories.
Dominant site of metastasis/relapse 
[Units: Participants]
 
Visceral   24 
Non Visceral   8 
Number of Lesions (Target + Non-Target) 
[Units: Participants]
 
0 or 1 lesion   0 
2 to 3 lesions   10 
> 3 lesions   22 
Dominant Lesion Site (Target + Non-Target) 
[Units: Participants]
 
Visceral   25 
Non visceral   7 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Who Achieved an Objective Confirmed Complete or Partial Overall Response   [ Time Frame: Objective response was evaluated every 2 cycles, up to a maximum of 39 cycles (approximately 39 months) ]

2.  Secondary:   Percentage of Participants With a Total Response   [ Time Frame: Evaluated every 2 cycles, up to a maximum of 39 cycles. ]

3.  Secondary:   Time to Disease Progression   [ Time Frame: Assessed every 2 cycles, up to a maximum of 39 cycles. ]

4.  Secondary:   Duration of Response   [ Time Frame: Assessed every 2 cycles, up to a maximum of 39 cycles. ]

5.  Secondary:   Overall Patient Survival   [ Time Frame: From Day 1 until approximately 44 months. ]

6.  Secondary:   Number of Participants With Adverse Events (AEs)   [ Time Frame: Day 1 up to 39 cycles ]


  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: NCT00093145     History of Changes
Obsolete Identifiers: NCT00085605
Other Study ID Numbers: CA016
First Submitted: October 4, 2004
First Posted: October 5, 2004
Results First Submitted: May 7, 2013
Results First Posted: July 17, 2013
Last Update Posted: July 17, 2013