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THOR Study: A Study of Continued Herceptin (Trastuzumab) in Combination With Second Line Chemotherapy in Patients With HER2 Positive Metastatic Breast Cancer.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00448279
First Posted: March 16, 2007
Last Update Posted: October 24, 2014
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.
Information provided by (Responsible Party):
Hoffmann-La Roche
Results First Submitted: October 21, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: trastuzumab
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
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 Alone Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
Chemotherapy Plus (+) Trastuzumab Participants received trastuzumab at either 2 milligrams per kilogram (mg/kg), intravenously (IV), every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.

Participant Flow:   Overall Study
    Chemotherapy Alone   Chemotherapy Plus (+) Trastuzumab
STARTED   29   29 
COMPLETED   0   0 
NOT COMPLETED   29   29 
Lost to Follow-up                2                2 
Adverse Event                1                1 
Disease progression                16                18 
Withdrawal by Subject                4                3 
Not specified                6                4 
Protocol Violation                0                1 



  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
Chemotherapy Alone Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
Chemotherapy + Trastuzumab Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
Total Total of all reporting groups

Baseline Measures
   Chemotherapy Alone   Chemotherapy + Trastuzumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 29   29   58 
Age 
[Units: Years]
Median (Full Range)
 59 
 (38 to 81) 
 57 
 (39 to 82) 
 58 
 (38 to 82) 
Gender 
[Units: Participants]
     
Female   29   29   58 
Male   0   0   0 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression-Free Survival (PFS) - Percentage of Participants With an Event   [ Time Frame: Baseline (BL) and every 8 weeks thereafter ]

2.  Primary:   Progression-Free Survival - Time to Event   [ Time Frame: BL and every 8 weeks thereafter ]

3.  Secondary:   Overall Survival (OS) - Percentage of Participants With an Event   [ Time Frame: BL and every 8 weeks thereafter ]

4.  Secondary:   Overall Survival - Time to Event   [ Time Frame: BL and every 8 weeks thereafter ]

5.  Secondary:   Percentage of Participants by Best Overall Response (BOR)   [ Time Frame: BL and every 8 weeks thereafter ]

6.  Secondary:   Percentage of Participants With a Best Overall Response of CR or PR   [ Time Frame: BL and every 8 weeks thereafter ]


  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



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00448279     History of Changes
Other Study ID Numbers: ML18742
First Submitted: March 15, 2007
First Posted: March 16, 2007
Results First Submitted: October 21, 2014
Results First Posted: October 24, 2014
Last Update Posted: October 24, 2014