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: June 5, 2015
Last verified: June 2015
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
  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
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     0 [1]   0 [1]
NOT COMPLETED     247     247  
Death                 99                 98  
Withdrawal by Subject                 30                 18  
Physician Decision                 11                 3  
Protocol Violation                 2                 8  
Lost to Follow-up                 7                 2  
Adverse Event                 5                 4  
Not specified                 1                 4  
Participant noncompliance                 2                 0  
Under study follow-up as of data cutoff                 90                 110  
[1] Data Cutoff 20 December 2013



  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.
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
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With Second-Line Progressive Disease (PD) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) or Death (Data Cutoff 20 December 2013)   [ Time Frame: Screening, BL (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 PD, or end of efficacy follow-up, up to data cutoff of 20 December 2013 (up to 35 months). ]

2.  Primary:   Second-Line PFS (Data Cutoff 20 December 2013)   [ Time Frame: Screening, BL (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until PD, or end of efficacy follow-up, up to data cutoff of 20 December 2013 (up to 35 months). ]

3.  Primary:   Probable Percentage of Participants Estimated to be Alive and Free of Disease Progression at 6, 12, 18, and 24 Months (Data Cutoff 20 December 2013)   [ Time Frame: Months 6, 12, 18, and 24 ]

4.  Secondary:   Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013)   [ Time Frame: Screening, BL (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until PD, or end of efficacy follow-up, up to data cutoff of 20 December 2013 (up to 35 months). ]

5.  Secondary:   Percentage of Participants With a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 (Data Cutoff 20 December 2013)   [ Time Frame: Screening, BL (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until PD, or end of efficacy follow-up, up to data cutoff of 20 December 2013 (up to 35 months). ]

6.  Secondary:   Percentage of Participants With a CR, PR, Stable Disease (SD), and PD According to RECIST v1.1 (Data Cutoff 20 December 2013)   [ Time Frame: Screening, BL (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until PD, or end of efficacy follow-up, up to data cutoff of 20 December 2013 (up to 35 months). ]

7.  Secondary:   Duration of Objective Response (DOR) (Data Cutoff 20 December 2013)   [ Time Frame: Screening, BL (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until PD, or end of efficacy follow-up, up to data cutoff of 20 December 2013 (up to 35 months). ]

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

9.  Secondary:   Percentage of Participants With Third-Line PD According to RECIST v1.1 or Death (Data Cutoff 20 December 2013)   [ Time Frame: Screening, BL (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until PD, or end of efficacy follow-up, up to data cutoff of 20 December 2013 (up to 35 months). ]

10.  Secondary:   Third-Line PFS (Data Cutoff 20 December 2013)   [ Time Frame: Screening, BL (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until PD, or end of efficacy follow-up, up to data cutoff of 20 December 2013 (up to 35 months). ]

11.  Secondary:   Percentage of Participants With Second- and Third-Line PD According to RECIST v1.1 or Death (Data Cutoff 20 December 2013)   [ Time Frame: Screening, BL (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until PD, or end of efficacy follow-up, up to data cutoff of 20 December 2013 (up to 35 months). ]

12.  Secondary:   Second- and Third-Line PFS (Data Cutoff 20 December 2013)   [ Time Frame: Screening, BL (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until PD, or end of efficacy follow-up, up to data cutoff of 20 December 2013 (up to 35 months). ]

13.  Secondary:   Percentage of Participants With Second- and Third-Line Tumor Progression (Data Cutoff 20 December 2013)   [ Time Frame: Screening, BL (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until PD, or end of efficacy follow-up, up to data cutoff of 20 December 2013 (up to 35 months). ]

14.  Secondary:   Time to Second- and Third-Line Tumor Progression (Data Cutoff 20 December 2013)   [ Time Frame: Screening, BL (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until PD, or end of efficacy follow-up, up to data cutoff of 20 December 2013 (up to 35 months). ]

15.  Secondary:   Percentage of Participants Who Died (Data Cutoff 20 December 2013)   [ Time Frame: Screening, BL, every 3-4 weeks thereafter according chemotherapy regimen until end of treatment or third-line PD, weekly thereafter until death or end of study up to data cutoff of 20 December 2013 (up to 35 months). ]

16.  Secondary:   Overall Survival (OS) (Data Cutoff 20 December 2013)   [ Time Frame: Screening, BL, every 3-4 weeks thereafter according chemotherapy regimen until end of treatment or third-line PD, weekly thereafter until death or end of study up to data cutoff of 20 December 2013 (up to 35 months). ]

17.  Secondary:   Probable Percentage of Participants Estimated to be Surviving at 6, 12, 18, and 24 Months (Data Cutoff 20 December 2013)   [ Time Frame: Months 6, 12, 18, and 24 ]

18.  Secondary:   Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)   [ Time Frame: BL, 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. ]

19.  Secondary:   Quality of Life Assessed As an Index Score Using the EQ-5D (Data Cutoff 20 December 2013)   [ Time Frame: BL, 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. ]

20.  Secondary:   Change From BL in EQ-5D Index Scores (Data Cutoff 20 December 2013)   [ Time Frame: BL, 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. ]

21.  Secondary:   Quality of Life Assessed Using the EQ-5D Visual Analogue Scale (VAS) Scores (Data Cutoff 20 December 2013)   [ Time Frame: BL, 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. ]

22.  Secondary:   Change From BL in VAS Scores (Data Cutoff 20 December 2013)   [ Time Frame: BL, 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. ]

23.  Secondary:   Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)   [ Time Frame: Screening, BL (≤28 days after randomization), every 8-9 weeks thereafter until second-line PD, or end of efficacy followup, up to data cutoff of 20 December 2013 (up to 35 months). ]

24.  Secondary:   Change From BL in FACT-B Scores (Data Cutoff 20 December 2013)   [ Time Frame: Screening, BL (≤28 days after randomization), every 8-9 weeks thereafter until second-line PD, or end of efficacy followup, up to data cutoff of 20 December 2013 (up to 35 months). ]


  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: Hoffman-LaRoche
phone: 800-821-8590
e-mail: genentech@druginfo.com


No publications provided


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: June 5, 2015
Health Authority: Argentina: Administración Nacional de Medicamentos, Alimentos y Tecnología Médica