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Trial record 1 of 1 for:    S0800
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S0800, Nab-Paclitaxel, Doxorubicin, Cyclophosphamide, and Pegfilgrastim With or Without Bevacizumab in Treating Women With Inflammatory or Locally Advanced Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00856492
First received: March 4, 2009
Last updated: May 23, 2017
Last verified: May 2017
Results First Received: November 15, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Biological: bevacizumab
Biological: pegfilgrastim
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: paclitaxel albumin-stabilized nanoparticle formulation

  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
No text entered.

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
Arm 1 (Nab-Paclitaxel + Bevacizumab / AC+PEG-G)) Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6).
Arm 2 (Nab-Paclitaxel / AC+PEG-G) Received nP x 12 without bevacizumab followed by ddAC x 6
Arm 3 (AC+PEG-G / Nab-Paclitaxel) ddAC x 6 followed by nP x 12 without bevacizumab

Participant Flow:   Overall Study
    Arm 1 (Nab-Paclitaxel + Bevacizumab / AC+PEG-G))   Arm 2 (Nab-Paclitaxel / AC+PEG-G)   Arm 3 (AC+PEG-G / Nab-Paclitaxel)
STARTED   99   63   53 
Toxicity Eval [1]   96   60   51 
COMPLETED   98   62   51 
NOT COMPLETED   1   1   2 
Ineligible or withdrew consent                1                1                2 
[1] Fewer pts evaluable for toxicity vs arm totals b/c 2 pts on each arm did not receive any treatment



  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
Arm 1 (Nab-Paclitaxel + Bevacizumab / AC+PEG-G) Received intravenous (IV) administration of nabpaclitaxel 100 mg/m2 IV weekly for 12 weeks (nP x 12) with IV bevacizumab 10 mg/kg every 2 weeks (six doses), followed by IV doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 with pegfilgrastim 6 mg subcutaneously every 2 weeks for six cycles (ddAC x 6).
Arm 2 (Nab-Paclitaxel / AC+PEG-G)) Received nP x 12 followed by ddAC x 6 without bevacizumab
Arm 3 (AC+PEG-G / Nab-Paclitaxel) Received ddAC x 6 first followed by nP x 12, without bevacizumab
Total Total of all reporting groups

Baseline Measures
   Arm 1 (Nab-Paclitaxel + Bevacizumab / AC+PEG-G)   Arm 2 (Nab-Paclitaxel / AC+PEG-G))   Arm 3 (AC+PEG-G / Nab-Paclitaxel)   Total 
Overall Participants Analyzed 
[Units: Participants]
 98   62   51   211 
Age 
[Units: Years]
Median (Full Range)
       
Participants Analyzed 
[Units: Participants]
 98   62   51   211 
   51.7 
 (22 to 71) 
 49.7 
 (33 to 75) 
 51.6 
 (31 to 66) 
 51.5 
 (22 to 75) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 98   62   51   211 
Female      98 100.0%      62 100.0%      51 100.0%      211 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
       
Race/Ethnicity         
Participants Analyzed 
[Units: Participants]
 98   62   51   211 
White      70  71.4%      44  71.0%      40  78.4%      154  73.0% 
Black      20  20.4%      14  22.6%      4   7.8%      38  18.0% 
Asian/Pacific Islander      5   5.1%      1   1.6%      5   9.8%      11   5.2% 
Other/unknown      3   3.1%      3   4.8%      2   3.9%      8   3.8% 
Inflammatory Breast Cancer (IBC) or Non-IBC Locally Advanced Breast Cancer (LABC) 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 98   62   51   211 
IBC      10  10.2%      7  11.3%      7  13.7%      24  11.4% 
Non-IBC LABC      88  89.8%      55  88.7%      44  86.3%      187  88.6% 
Hormone receptor status 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 98   62   51   211 
Positive: ER+ or PgR+      66  67.3%      43  69.4%      35  68.6%      144  68.2% 
Negative: ER- and PR- (TNBC)      32  32.7%      19  30.6%      16  31.4%      67  31.8% 
Breast cancer stage [1] [2] 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 98   62   50   210 
IIB      35  35.7%      30  48.4%      22  44.0%      87  41.4% 
IIIA      32  32.7%      16  25.8%      14  28.0%      62  29.5% 
IIIB      29  29.6%      12  19.4%      12  24.0%      53  25.2% 
IIIC      2   2.0%      4   6.5%      2   4.0%      8   3.8% 
[1]

Measure Description: As per AJCC 6th ed, 2002:

https://cancerstaging.org/references-tools/deskreferences/Documents/AJCC6thEdCancerStagingManualPart2.pdf

[2] One subject missing Breast cancer stage information at baseline.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Patients With Pathological Complete Response Rate   [ Time Frame: pre-study pathology vs. post-chemo surgery pathology (approx. 39-42 weeks post-randomization) ]

2.  Secondary:   Overall Survival   [ Time Frame: Disease assessed every 4 weeks while on treatment then every 6 months for one year then annually for four years from registration. ]

3.  Secondary:   Event-free Survival   [ Time Frame: Disease assessed every 4 weeks while on treatment then every 6 months for one year then annually for four years from registration or until recurrence ]

4.  Secondary:   Number of Adverse Events That Are Possibly, Probably or Definitely Related to Study Drug   [ Time Frame: Up to 28 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Breast Committee Statistician
Organization: SWOG Statistical Center
phone: 206-667-4623



Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00856492     History of Changes
Other Study ID Numbers: CDR0000636131
S0800 ( Other Identifier: SWOG )
U10CA032102 ( US NIH Grant/Contract Award Number )
Study First Received: March 4, 2009
Results First Received: November 15, 2016
Last Updated: May 23, 2017