We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Paclitaxel With or Without Carboplatin and/or Bevacizumab Followed by Doxorubicin and Cyclophosphamide in Treating Patients With Breast Cancer That Can Be Removed by Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00861705
First Posted: March 13, 2009
Last Update Posted: October 19, 2015
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):
National Cancer Institute (NCI)
Results First Submitted: January 12, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Estrogen Receptor Negative
HER2/Neu Negative
Male Breast Carcinoma
Progesterone Receptor Negative
Stage IIA Breast Cancer
Stage IIB Breast Cancer
Stage IIIA Breast Cancer
Triple-Negative Breast Carcinoma
Interventions: Biological: Bevacizumab
Drug: Carboplatin
Drug: Cyclophosphamide
Drug: Doxorubicin Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel

  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 (Pac --> ddAC)

Patients receive paclitaxel (pac) IV over 60 minutes once weekly in weeks 1-12. Patients then receive dose-dense doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 5-30 minutes (ddAC) once in weeks 13, 15, 17, and 19.

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

cyclophosphamide: Given IV

Arm 2 (Pac + Bev --> ddAC + Bev)

Patients receive pac and ddAC as in arm 1. Patients also receive bevacizumab (bev) IV over 30-90 minutes in weeks 1, 3, 5, 7, 9, 11, 13, 15, and 17.

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

cyclophosphamide: Given IV

bevacizumab: Given IV

Arm 3 (Pac + Carboplatin --> ddAC)

Patients receive pac and ddAC as in arm 1. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10.

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

cyclophosphamide: Given IV

carboplatin: Given IV

Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)

Patients receive pac and ddAC as in arm 1, bev as in arm 2, and carboplatin as in arm 3.

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

cyclophosphamide: Given IV

bevacizumab: Given IV

carboplatin: Given IV


Participant Flow:   Overall Study
    Arm 1 (Pac --> ddAC)   Arm 2 (Pac + Bev --> ddAC + Bev)   Arm 3 (Pac + Carboplatin --> ddAC)   Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)
STARTED   115   113   113   113 
COMPLETED   108   110   113   112 
NOT COMPLETED   7   3   0   1 
Never Began Treatment                7                3                0                1 



  Baseline Characteristics
  Hide Baseline Characteristics

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.
Using a modified intent-to-treat approach only patients who began protocol treatment (n=443) were included in analyses for neoadjuvant treatment and toxicity. Analyses for surgical endpoints excluded 10 patients who withdrew consent prior to surgery (n=433). All analyses considered patients according to treatment assignment.

Reporting Groups
  Description
Arm 1 (Pac --> ddAC)

Patients receive paclitaxel (pac) IV over 60 minutes once weekly in weeks 1-12. Patients then receive dose-dense doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 5-30 minutes (ddAC) once in weeks 13, 15, 17, and 19.

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

cyclophosphamide: Given IV

Arm 2 (Pac + Bev --> ddAC + Bev)

Patients receive pac and ddAC as in arm 1. Patients also receive bevacizumab (bev) IV over 30-90 minutes in weeks 1, 3, 5, 7, 9, 11, 13, 15, and 17.

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

cyclophosphamide: Given IV

bevacizumab: Given IV

Arm 3 (Pac + Carboplatin --> ddAC)

Patients receive pac and ddAC as in arm 1. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10.

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

cyclophosphamide: Given IV

carboplatin: Given IV

Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)

Patients receive pac and ddAC as in arm 1, bev as in arm 2, and carboplatin as in arm 3.

doxorubicin hydrochloride: Given IV

paclitaxel: Given IV

cyclophosphamide: Given IV

bevacizumab: Given IV

carboplatin: Given IV

Total Total of all reporting groups

Baseline Measures
   Arm 1 (Pac --> ddAC)   Arm 2 (Pac + Bev --> ddAC + Bev)   Arm 3 (Pac + Carboplatin --> ddAC)   Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)   Total 
Overall Participants Analyzed 
[Units: Participants]
 115   113   113   113   454 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.2  (11.1)   48.3  (10.8)   50.9  (10.8)   47.1  (9.8)   49.1  (10.7) 
Gender 
[Units: Participants]
         
Female   115   113   113   113   454 
Male   0   0   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
         
American Indian or Alaska Native   1   0   0   2   3 
Asian   1   5   4   3   13 
Native Hawaiian or Other Pacific Islander   1   0   0   0   1 
Black or African American   20   21   27   21   89 
White   86   84   80   81   331 
More than one race   1   1   1   2   5 
Unknown or Not Reported   5   2   1   4   12 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is).   [ Time Frame: At the time of definitive surgical removal, up to 28 weeks ]

2.  Primary:   Pathologic Complete Response (pCR) in the Breast. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is).   [ Time Frame: At the time of definitive surgical removal, up to 28 weeks ]

3.  Secondary:   Pathologic Complete Response (pCR) in the Breast and Axilla. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is) Plus the Absence of Any Tumor Deposit >0.2 mm in Sampled Axillary Nodes (ypT0/isN0).   [ Time Frame: At the time of definitive surgical removal, up to 28 weeks ]

4.  Secondary:   Pathologic Complete Response (pCR) in the Breast and Axilla. Defined as the Absence of Residual Invasive Carcinoma in the Breast (ypT0/is) Plus the Absence of Any Tumor Deposit >0.2 mm in Sampled Axillary Nodes (ypT0/isN0).   [ Time Frame: At the time of definitive surgical removal, up to 28 weeks ]

5.  Secondary:   Incidence and Severity of Post-op Complications, Namely Excessive Bleeding, Delayed Wound Healing, and Wound Dehiscence.   [ Time Frame: at definitive surgery, up to 28 weeks ]

6.  Secondary:   Pathologic Stage in the Breast and in the Breast Plus Axilla as Measured by American Joint Committee on Cancer (AJCC) Tumor Node Metastasis (TNM) Staging Criteria (Version 6)   [ Time Frame: at definitive surgery, up to 28 weeks ]
Results not yet reported.   Anticipated Reporting Date:   10/2018  

7.  Secondary:   Radiographic Response Assessed by Tumor Measurement   [ Time Frame: Baseline; at completion of neoadjuvant therapy ]
Results not yet reported.   Anticipated Reporting Date:   10/2018  

8.  Secondary:   Clinical Response Assessed by Tumor Measurement   [ Time Frame: Baseline; at completion of neoadjuvant therapy ]
Results not yet reported.   Anticipated Reporting Date:   10/2018  

9.  Secondary:   Overall Survival   [ Time Frame: up to 10 years ]
Results not yet reported.   Anticipated Reporting Date:   10/2018  

10.  Secondary:   Recurrence-free Survival   [ Time Frame: up to 10 years ]
Results not yet reported.   Anticipated Reporting Date:   10/2018  

11.  Secondary:   Time to First Failure, Defined as First Instance of Ipsilateral Invasive Breast Tumor Recurrence, Local/Regional Invasive Breast Cancer Recurrence, Distant Recurrence, or Death From Any Cause   [ Time Frame: up to 10 years ]
Results not yet reported.   Anticipated Reporting Date:   10/2018  


  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
  Hide More Information

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: William M. Sikov, M.D.
Organization: Warren Alpert Medical School of Brown University, Department of Medicine
phone: 401-793-7151
e-mail: wsikov@lifespan.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00861705     History of Changes
Other Study ID Numbers: NCI-2009-01172
NCI-2009-01172 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CALGB-40603
CALGB 40603/CTSU 40603
CDR0000636850
CALGB 40603 ( Other Identifier: Alliance for Clinical Trials in Oncology )
CALGB-40603 ( Other Identifier: CTEP )
U10CA180821 ( U.S. NIH Grant/Contract )
U10CA031946 ( U.S. NIH Grant/Contract )
First Submitted: March 12, 2009
First Posted: March 13, 2009
Results First Submitted: January 12, 2015
Results First Posted: March 23, 2015
Last Update Posted: October 19, 2015



To Top