A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Breast Cancer Progressing After First-Line Therapy With Avastin and Chemotherapy (TANIA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01250379
First received: November 25, 2010
Last updated: January 12, 2016
Last verified: January 2016
Results First Received: June 5, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: bevacizumab [Avastin]
Drug: Chemotherapy

  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
A total of 556 participants were screened and of these, 494 were randomized.

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
Chemotherapy (CT) Arm Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
Chemotherapy Plus Bevacizumab (CT+BV) Arm Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 milligrams per kilogram (mg/kg), intravenously (IV), every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.

Participant Flow:   Overall Study
    Chemotherapy (CT) Arm     Chemotherapy Plus Bevacizumab (CT+BV) Arm  
STARTED     247     247  
COMPLETED     45 [1]   54 [1]
NOT COMPLETED     202     193  
Death                 141                 148  
Withdrawal by Subject                 32                 20  
Physician Decision                 11                 3  
Protocol Violation                 2                 8  
Lost to Follow-up                 9                 6  
Adverse Event                 5                 4  
Not specified                 0                 4  
Participant noncompliance                 2                 0  
[1] Participants under study follow-up as of Data Cutoff 30 April 2015 were considered as completers.



  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 (ITT) population: all randomized participants.

Reporting Groups
  Description
CT Arm Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
CT+BV Arm Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
Total Total of all reporting groups

Baseline Measures
    CT Arm     CT+BV Arm     Total  
Number of Participants  
[units: participants]
  247     247     494  
Age  
[units: years]
Mean (Standard Deviation)
  54.7  (10.83)     55.8  (11.17)     55.2  (11.01)  
Gender  
[units: participants]
     
Female     247     247     494  
Male     0     0     0  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Second-Line Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)   [ Time Frame: Baseline (less than or equal to [≤] 28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years ]

2.  Primary:   Second-Line PFS   [ Time Frame: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years ]

3.  Primary:   Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 6   [ Time Frame: Month 6 ]

4.  Primary:   Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 12   [ Time Frame: Month 12 ]

5.  Primary:   Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 18   [ Time Frame: Month 18 ]

6.  Primary:   Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 24   [ Time Frame: Month 24 ]

7.  Secondary:   Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013)   [ Time Frame: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years ]

8.  Secondary:   Percentage of Participants With a Second-Line Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 (Data Cutoff 20 December 2013)   [ Time Frame: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years ]

9.  Secondary:   Percentage of Participants With a Second-Line CR, PR, Stable Disease, and PD According to RECIST v1.1 (Data Cutoff 20 December 2013)   [ Time Frame: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years ]

10.  Secondary:   Duration of Second-Line Objective Response (Data Cutoff 20 December 2013)   [ Time Frame: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years ]

11.  Secondary:   Percentage of Participants With a Second-Line Documented CR or PR According to RECIST v1.1 Estimated to be Alive and Free of Disease Progression at Months 3, 6, and 9 (Data Cutoff 20 December 2013)   [ Time Frame: Months 3, 6, and 9 ]

12.  Secondary:   Percentage of Participants With Third-Line PFS According to RECIST v1.1   [ Time Frame: First dose of third-line treatment until PD or death due to any cause (assessed every 8-9 weeks, over a period of approximately 14 months) ]

13.  Secondary:   Third-Line PFS   [ Time Frame: First dose of third-line treatment until PD or death due to any cause (over a period of approximately 14 months) ]

14.  Secondary:   Percentage of Participants With Second- and Third-Line PFS According to RECIST v1.1   [ Time Frame: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years ]

15.  Secondary:   Second- and Third-Line PFS   [ Time Frame: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years ]

16.  Secondary:   Percentage of Participants With Second- and Third-Line Tumor Progression   [ Time Frame: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years ]

17.  Secondary:   Time to Second- and Third-Line Tumor Progression   [ Time Frame: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years ]

18.  Secondary:   Percentage of Participants Who Died   [ Time Frame: Baseline until death (up to approximately 4 years) ]

19.  Secondary:   Overall Survival (OS)   [ Time Frame: Baseline until death (up to approximately 4 years) ]

20.  Secondary:   Percentage of Participants Estimated to be Surviving at Months 6, 12, 18, and 24   [ Time Frame: Months 6, 12, 18, and 24 ]

21.  Secondary:   Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)   [ Time Frame: Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years) ]

22.  Secondary:   Quality of Life Assessed As an Index Score Using the EQ-5D (Data Cutoff 20 December 2013)   [ Time Frame: Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years) ]

23.  Secondary:   Change From Baseline in EQ-5D Index Scores (Data Cutoff 20 December 2013)   [ Time Frame: Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years) ]

24.  Secondary:   Quality of Life Assessed Using the EQ-5D Visual Analogue Scale (VAS) Scores (Data Cutoff 20 December 2013)   [ Time Frame: Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years) ]

25.  Secondary:   Change From Baseline in VAS Scores (Data Cutoff 20 December 2013)   [ Time Frame: Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years) ]

26.  Secondary:   Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)   [ Time Frame: Baseline (≤28 days after randomization), every 8-9 weeks thereafter until second-line PD (up to approximately 3 years) ]

27.  Secondary:   Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)   [ Time Frame: Baseline (≤28 days after randomization), every 8-9 weeks thereafter until second-line PD (up to approximately 3 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: Hoffman-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: NCT01250379     History of Changes
Other Study ID Numbers: MO22998
2010-020998-16
Study First Received: November 25, 2010
Results First Received: June 5, 2015
Last Updated: January 12, 2016
Health Authority: Argentina: Administración Nacional de Medicamentos, Alimentos y Tecnología Médica