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Chemotherapy With or Without Bevacizumab in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer That Can Be Removed By Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00408408
First Posted: December 7, 2006
Last Update Posted: September 18, 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):
NSABP Foundation Inc
Results First Submitted: March 23, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Biological: bevacizumab
Drug: capecitabine
Drug: cyclophosphamide
Drug: docetaxel
Drug: doxorubicin hydrochloride (Adriamycin)
Drug: gemcitabine hydrochloride

  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
No text entered.

Reporting Groups
  Description
Arm 1A: Docetaxel Then AC

Patients receive docetaxel IV on day 1 every 3 weeks for up to 4 cycles. Patients then receive AC IV every 3 weeks for up to 4 cycles. Patients then undergo surgery (lumpectomy or mastectomy).

cyclophosphamide: 600 mg/m2 IV

docetaxel: 100 mg/m2 IV

doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV

Arm 1B Docetaxel + Bev Then AC + Bev

Patients receive bevacizumab (bev) IV on day 1 and docetaxel every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab IV every 3 weeks for up to 10 cycles in the absence of disease progression or unacceptable toxicity.

bevacizumab: 15 mg/kg IV

cyclophosphamide: 600 mg/m2 IV

docetaxel: 100 mg/m2 IV

doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV

Arm 2A: Docetaxel + Capecitabine Then AC

Patients receive docetaxel as in Arm 1A and oral capecitabine (cape) twice daily on days 1-14 every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A.

capecitabine: 825 mg/m2 orally

cyclophosphamide: 600 mg/m2 IV

docetaxel: 100 mg/m2 IV

doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV

Arm 2B: Docetaxel + Cape + Bev Then AC + Bev

Patients receive bevacizumab as in Arm 1B and docetaxel and capecitabine as in Arm III. Treatment repeats every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1B. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B.

bevacizumab: 15 mg/kg IV

capecitabine: 825 mg/m2 orally

cyclophosphamide: 600 mg/m2 IV

docetaxel: 100 mg/m2 IV

doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV

Arm 3A: Docetaxel + Gem Then AC

Patients receive docetaxel as in Arm 1A and gemcitabine hydrochloride IV on days 1 and 8 of each cycle every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A.

cyclophosphamide: 600 mg/m2 IV

docetaxel: 100 mg/m2 IV

doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV

gemcitabine hydrochloride: 1000 mg/m2 IV

Arm 3B: Docetaxel + Gem + Bev Then AC + Bev

Patients receive docetaxel as in Arm 1A, gemcitabine hydrochloride as in Arm 3A, and bevacizumab as in Arm 1B. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B.

bevacizumab: 15 mg/kg IV

cyclophosphamide: 600 mg/m2 IV

docetaxel: 100 mg/m2 IV

doxorubicin hydrochloride (Adriamycin): 60 mg/m2 IV

gemcitabine hydrochloride: 1000 mg/m2 IV


Participant Flow:   Overall Study
    Arm 1A: Docetaxel Then AC   Arm 1B Docetaxel + Bev Then AC + Bev   Arm 2A: Docetaxel + Capecitabine Then AC   Arm 2B: Docetaxel + Cape + Bev Then AC + Bev   Arm 3A: Docetaxel + Gem Then AC   Arm 3B: Docetaxel + Gem + Bev Then AC + Bev
STARTED   201   199   204   201   197   204 
COMPLETED   199   196   204   194   192   201 
NOT COMPLETED   2   3   0   7   5   3 
No follow up data                2                3                0                7                5                3 



  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
Docetaxel Then AC Docetaxel then AC
Docetaxel + Bev Then AC + Bev Docetaxel + Bev then AC + Bev
Docetaxel + Capecitabine Then AC Docetaxel + Capecitabine then AC
Docetaxel + Cape + Bev Then AC + Bev Docetaxel + Cape + Bev then AC + Bev
Docetaxel + Gem Then AC Docetaxel + Gem then AC
Docetaxel + Gem + Bev Then AC + Bev Docetaxel + Gem + Bev then AC + Bev
Total Total of all reporting groups

Baseline Measures
   Docetaxel Then AC   Docetaxel + Bev Then AC + Bev   Docetaxel + Capecitabine Then AC   Docetaxel + Cape + Bev Then AC + Bev   Docetaxel + Gem Then AC   Docetaxel + Gem + Bev Then AC + Bev   Total 
Overall Participants Analyzed 
[Units: Participants]
 201   199   204   201   197   204   1206 
Age 
[Units: Years]
Mean (Standard Deviation)
 48  (9.1)   49  (9.6)   49  (9.8)   49  (10.4)   48  (9.9)   48  (9.8)   48  (9.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
             
Female      201 100.0%      199 100.0%      204 100.0%      201 100.0%      197 100.0%      204 100.0%      1206 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Pathologic Complete Response (pCR) of the Primary Tumor in the Breast   [ Time Frame: Time of surgery, on average 6 or 13 months ]

2.  Secondary:   pCR in the Breast and Nodes   [ Time Frame: Time of surgery, on average 6 or 13 months ]

3.  Secondary:   Clinical Overall Response (cOR) Following Docetaxel Alone, Docetaxel/Capecitabine, and Docetaxel/Gemcitabine Hydrochloride, With or Without Bevacizumab, as Assessed by Physical Exam at the Completion of the Docetaxel-based Portion of Chemotherapy   [ Time Frame: Assessed at cycle 5 of chemotherapy, on average at 15 weeks ]

4.  Secondary:   Clinical Overall Response: cOR as Assessed by Physical Exam at the Completion of the Sequential Chemotherapy Regimens   [ Time Frame: Three to four weeks after the last chemotherapy dose on average 6 or 13 months ]

5.  Secondary:   Clinical Complete Response (cCR) Following Docetaxel Alone, Docetaxel/Capecitabine, and Docetaxel/Gemcitabine Hydrochloride, With or Without Bevacizumab, as Assessed by Physical Exam at Completion of Therapy   [ Time Frame: Assessed at cycle 5 of chemotherapy, on average at 15 weeks ]

6.  Secondary:   Clinical Complete Resonse: cCR as Assessed by Physical Exam at the Completion of the Sequential Chemotherapy Regimens   [ Time Frame: Three to four weeks after the last chemotherapy dose, on average at 6 or 13 months ]

7.  Secondary:   Surgical Complication   [ Time Frame: 24 months after study entry ]

8.  Secondary:   Toxicities Including Events Other Than Congestive Heart Failure, of Chemotherapy Alone, Bevacizumab With Chemotherapy, and Bevacizumab Alone   [ Time Frame: 24 months after study entry ]

9.  Secondary:   Disease-free Survival (DFS)   [ Time Frame: Measured through 5 years after study enrollment ]

10.  Secondary:   Percentage of Cardiac Events   [ Time Frame: After each cycle, 3-5 weeks postoperative, 9 and 12 months from study entry, every 6 month years 2-5, and annually years 6-10, for postoperative bevacizumab patients, every 6 weeks during postoperative therapy and at 18 months following study entry. ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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:  
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: Director, Department of Regulatory Affairs
Organization: NSABP Foundation, Inc
phone: 412-339-5300
e-mail: regulatory@nsabp.org


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

Responsible Party: NSABP Foundation Inc
ClinicalTrials.gov Identifier: NCT00408408     History of Changes
Other Study ID Numbers: NSABP B-40
First Submitted: December 6, 2006
First Posted: December 7, 2006
Results First Submitted: March 23, 2017
Results First Posted: September 18, 2017
Last Update Posted: September 18, 2017