LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01125566
First received: May 10, 2010
Last updated: August 5, 2014
Last verified: August 2014
Results First Received: June 6, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Neoplasms
Interventions: Drug: BIBW 2992
Drug: trastuzumab
Drug: vinorelbine

  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
Afatinib+ Vinorelbine (AV) Patients received continuous daily treatment with afatinib at a starting dose of 40 mg once daily and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days. For afatinib, a protocol- defined dose-reduction scheme was to be followed if a patient experienced certain pre-specified adverse events. All patients without disease progression who were on treatment on 26Apr2013 had to immediately discontinue Afatinib+ Vinorelbine combination treatment. Patients in this group could continue with either vinorelbine or afatinib monotherapy if they experienced clinical benefit.
Trastuzumab+ Vinorelbine (TV) Patients received weekly infusion of Trastuzumab (2 mg/ kg, following an initial loading dose of 4 mg/ kg) and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days.
AV Switched to TV This group describes patients who crossed over from AV to TV following DMC recommendation to terminate recruitment on 26Apr2013. Patients discontinued AV and switched to TV if they were without disease progression on Afatinib+ Vinorelbine treatment on 26Apr2013.

Participant Flow for 2 periods

Period 1:   Patients Before the Switch (26Apr2013)
    Afatinib+ Vinorelbine (AV)     Trastuzumab+ Vinorelbine (TV)     AV Switched to TV  
STARTED     339 [1]   169 [1]   0 [2]
COMPLETED     79 [3]   33 [4]   0 [2]
NOT COMPLETED     260     136     0  
Progressive disease according to RECIST                 181                 100                 0  
Worsening of underlying cancer disease                 5                 4                 0  
Adverse Event                 24                 5                 0  
Protocol Violation                 0                 1                 0  
Refused to continue taking medication                 25                 21                 0  
Not treated                 2                 0                 0  
Other than those stated above                 23                 5                 0  
[1] Randomised
[2] N/A
[3] All patients without disease progression who were on treatment on 08Jun2013
[4] On treatment at analysis cut-off date (03Sep2013)

Period 2:   Patients Who Switched From AV to TV
    Afatinib+ Vinorelbine (AV)     Trastuzumab+ Vinorelbine (TV)     AV Switched to TV  
STARTED     0 [1]   0 [1]   73 [2]
COMPLETED     0 [1]   0 [1]   49 [3]
NOT COMPLETED     0     0     24  
Progressive disease according to RECIST                 0                 0                 20  
Refused to continue taking medication                 0                 0                 4  
[1] N/A
[2] All patients without disease progression who chose to switch from AV to TV by 08Jun2013
[3] On TV treatment at analysis cut-off date (03Sep2013)



  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.
Treated Set :The treated set included all randomised patients who were documented to have taken at least 1 dose of study medication (One centre was excluded from analysis due to serious non-compliance, thus data from 5 patients in AV arm and 1 patient in TV arm were excluded)

Reporting Groups
  Description
Afatinib + Vinorelbine (AV) Patients received continuous daily treatment with afatinib at a starting dose of 40 mg once daily and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days. For afatinib, a protocol- defined dose-reduction scheme was to be followed if a patient experienced certain pre-specified adverse events. All patients without disease progression who were on treatment on 26Apr2013 had to immediately discontinue Afatinib+ Vinorelbine combination treatment. Patients in this group could continue with either vinorelbine or afatinib monotherapy if they experienced clinical benefit.
Trastuzumab + Vinorelbine (TV) Patients received weekly infusion of Trastuzumab (2 mg/ kg, following an initial loading dose of 4 mg/ kg) and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days.
Total Total of all reporting groups

Baseline Measures
    Afatinib + Vinorelbine (AV)     Trastuzumab + Vinorelbine (TV)     Total  
Number of Participants  
[units: participants]
  332     168     500  
Age  
[units: years]
Mean ± Standard Deviation
  51.8  ± 11.3     53.1  ± 12.3     52.2  ± 11.6  
Gender  
[units: participants]
     
Female     332     168     500  
Male     0     0     0  



  Outcome Measures
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1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: From randomization until disease progression, death or data cut-off (08Jun2013); Up to 34 months ]

2.  Secondary:   Objective Response (OR)   [ Time Frame: Post baseline tumour-imaging was performed at Week 8, 16, 24, 32, 40, 48, 56 and then every 12 weeks (Up to 34 months) ]

3.  Secondary:   Best RECIST Assessment   [ Time Frame: Post baseline tumour-imaging was performed at Week 8, 16, 24, 32, 40, 48, 56 and then every 12 weeks (Data collected until cut-off date 08Jun2013; Up to 34 months) ]

4.  Secondary:   Overall Survival (OS)   [ Time Frame: From randomisation to data cut-off (03Sep2013); Up to 37 months. ]


  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
The Data Monitoring Committee recommended termination of recruitment due to low likelihood of the study meeting its primary objectives.


  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: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided


Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01125566     History of Changes
Other Study ID Numbers: 1200.75, 2009-015476-98
Study First Received: May 10, 2010
Results First Received: June 6, 2014
Last Updated: August 5, 2014
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