Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

A Study of Bevacizumab in Combination With Gemcitabine and Carboplatin in Participants With Triple Negative Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01201265
First received: September 6, 2010
Last updated: April 21, 2016
Last verified: April 2016
Results First Received: April 21, 2016  
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: Bevacizumab
Drug: Carboplatin
Drug: Gemcitabine

  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
All Participants Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.

Participant Flow:   Overall Study
    All Participants
STARTED   40 
COMPLETED   2 
NOT COMPLETED   38 
Death                14 
Insufficient Therapeutic Response                3 
Lost to Follow-up                10 
Withdrawal by Subject                7 
Disease Progression                4 



  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.
No text entered.

Reporting Groups
  Description
All Participants Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.

Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
 40 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.5  (10.68) 
Gender 
[Units: Participants]
 
Female   40 
Male   0 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: From the date of registration until the disease progression or death (up to 1541 days). ]

2.  Secondary:   Percentage of Participants Achieving an Overall Response   [ Time Frame: From the date of registration until the disease progression or death (up to 1541 days) ]

3.  Secondary:   Percentage of Participants Achieving a Clinical Benefit Response (CBR)   [ Time Frame: From the date of registration until the disease progression or death (up to 1541 days) ]

4.  Secondary:   Time to Progression (TTP)   [ Time Frame: From the date of registration until the disease progression (up to 1541 days). ]

5.  Secondary:   Overall Survival (OS)   [ Time Frame: From the date of registration until the disease progression or death (up to 1541 days) ]

6.  Secondary:   Number of Participants With an Adverse Event (AE)   [ Time Frame: Up to 28 days after termination of study treatment (approximately 1569 days) ]

7.  Secondary:   Change From Baseline to Cycle 6 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30)   [ Time Frame: Baseline, cycle 6 ]

8.  Secondary:   Change From Baseline in Systolic Blood Pressure (SBP)   [ Time Frame: Baseline, Cycle 6, 12 of treatment ]

9.  Secondary:   Change From Baseline in Diastolic Blood Pressure (DBP)   [ Time Frame: Baseline, Cycle 6, 12 of treatment ]


  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 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-La Roche
phone: 800-821-8590



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01201265     History of Changes
Other Study ID Numbers: ML25420
Study First Received: September 6, 2010
Results First Received: April 21, 2016
Last Updated: April 21, 2016
Health Authority: India: Ministry of Health