A Study of Avastin (Bevacizumab) Plus Herceptin (Trastuzumab) in Patients With Primary Inflammatory HER2-Positive Breast Cancer.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00717405
First received: July 16, 2008
Last updated: December 1, 2015
Last verified: December 2015
Results First Received: December 1, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Standard chemotherapy
Drug: bevacizumab [Avastin]
Drug: trastuzumab [Herceptin]

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Bevacizumab + Trastuzumab Chemotherapy Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 milligrams per kilogram (mg/kg) intravenous (IV) bevacizumab every 3 weeks (q3w) for 8 cycles, 4 cycles of 500 milligrams per squared-meter (mg/m^2) IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.

Participant Flow:   Overall Study
    Bevacizumab + Trastuzumab Chemotherapy  
STARTED     52  
COMPLETED     52  
NOT COMPLETED     0  



  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.
Intent to treat population (ITT): Included all enrolled participants who had at least 1 post baseline assessment.

Reporting Groups
  Description
Bevacizumab + Trastuzumab Neoadjuvant treatment (Cycles 1-8, 3-week cycle): Participants received 15 mg/kg IV bevacizumab q3w for 8 cycles, 4 cycles of 500 mg/m^2 IV 5-fluorouracil, 100 mg/m^2 IV epirubicin, and 500 mg/m^2 IV cyclophosphamide, q3w, followed by 4 cycles of 100 mg/m^2 IV docetaxel q3w plus trastuzumab (loading dose of 8 mg/kg and then 6 mg/kg q3w). Participants underwent surgery (mastectomy) after neoadjuvant treatment, maintaining trastuzumab (6 mg/kg). Adjuvant treatment: Participants received radiotherapy 2-4 weeks after surgery and lasted for 4-6 weeks, 6 mg/kg IV trastuzumab q3w and 15 mg/kg IV bevacizumab q3w administered along with/after the radiotherapy (administered up to a cumulative [neoadjuvant + adjuvant] total of 18 injections each. Hormonal therapy (at investigator discretion) after the end of radiotherapy was administered for 5 years, if participant was hormone receptor positive.

Baseline Measures
    Bevacizumab + Trastuzumab  
Number of Participants  
[units: participants]
  52  
Age  
[units: years]
Mean (Standard Deviation)
  51.48  (9.78)  
Gender  
[units: participants]
 
Female     52  
Male     0  



  Outcome Measures
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1.  Primary:   Percentage of Participants With a Pathological Complete Response (PCR) According to the Sataloff Classification   [ Time Frame: From baseline through Week 25 (Up to 6 months) ]

2.  Secondary:   Percentage of Participants With a PCR According to the Chevallier Classification   [ Time Frame: From baseline through Week 25 (Up to 6 months) ]

3.  Secondary:   Percentage of Participants Who Were Responders Based on Inflammatory Signs From Baseline at Cycle 5 and Final Treatment Visit   [ Time Frame: Baseline, Cycle 5 (Week 15), Neo-adjuvant treatment final visit (Week 25) ]

4.  Secondary:   Percentage of Participants Who Were Responders Based on Overall Clinical Response From Baseline at Cycle 5 and Final Treatment Visit   [ Time Frame: Baseline, Cycle 5 (Week 15), Neo-adjuvant treatment final visit (Week 25) ]

5.  Secondary:   Number of Participants Who Underwent Mastectomy   [ Time Frame: Anytime between Week 26 and Week 29 ]

6.  Secondary:   Percentage of Participants With Macroscopically Visible Tumor   [ Time Frame: Anytime between Week 26 and Week 29 ]

7.  Secondary:   Percentage of Participants Who Underwent Lymph Node Resection   [ Time Frame: Anytime between Week 26 and Week 29 ]

8.  Secondary:   Breast Cancer Marker CA15.3 at Baseline, Neoadjuvant Final Visit and Change From Baseline at Neoadjuvant Final Visit   [ Time Frame: Baseline, Neoadjuvant Final Visit (Week 25) ]

9.  Secondary:   Percentage of Participants Who Were Disease Free at 3 and 5 Years   [ Time Frame: 3, 5 years ]

10.  Secondary:   Disease Free Survival (DFS) Duration   [ Time Frame: Up to 5 Years ]

11.  Secondary:   Percentage of Participants Who Were Recurrence Free at 3 and 5 Years   [ Time Frame: 3, 5 years ]

12.  Secondary:   Recurrence Free Survival (RFS) Duration   [ Time Frame: Up to 5 Years ]

13.  Secondary:   Percentage of Participants Who Were Alive at 3 and 5 Years   [ Time Frame: 3, 5 years ]

14.  Secondary:   Overall Survival (OS) Duration   [ Time Frame: Up to 5 years ]


  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 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: Medical Communications
Organization: Hoffmann-LaRoche
phone: 800-821-8590
e-mail: genentech@druginfo.com


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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00717405     History of Changes
Other Study ID Numbers: ML21531
2008-000783-16
Study First Received: July 16, 2008
Results First Received: December 1, 2015
Last Updated: December 1, 2015
Health Authority: France: Agence francaise de securite sanitaire des produits de sante (AFSSAPS)