BIBW 2992 and Letrozole in Hormonoresistant Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00708214
First received: June 30, 2008
Last updated: December 5, 2013
Last verified: October 2013
Results First Received: August 8, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Neoplasms
Interventions: Drug: BIBW 2992
Drug: Letrozole

  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
According to the protocol the starting dose of Afatinib was 50mg/day. This dose was reduced according to the protocol to first 40mg/day and then to 30mg/day due to skin toxicity.

Reporting Groups
  Description
Afatinib 50 mg With Letrozole Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
Afatinib 40 mg With Letrozole Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
Afatinib 30 mg With Letrozole Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.

Participant Flow:   Overall Study
    Afatinib 50 mg With Letrozole     Afatinib 40 mg With Letrozole     Afatinib 30 mg With Letrozole  
STARTED     7     13     8  
COMPLETED     0 [1]   0 [1]   0 [1]
NOT COMPLETED     7     13     8  
Other Adverse Event                 3                 6                 2  
Unknown                 0                 1                 1  
Progressive Disease                 4                 6                 5  
[1] On treatment at analysis cut-off date (04 Jan 2010)



  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 (TS). TS consisted of all patients who were dispensed study medication and have taken at least 1 dose of Afatinib.

Reporting Groups
  Description
Afatinib 50 mg With Letrozole Patients received continuous daily dosing with Afatinib 50 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
Afatinib 40 mg With Letrozole Patients received continuous daily dosing with Afatinib 40 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
Afatinib 30 mg With Letrozole Patients received continuous daily dosing with Afatinib 30 mg therapy with letrozole 2.5 mg over 28-day treatment cycles until further disease progression.
Total Total of all reporting groups

Baseline Measures
    Afatinib 50 mg With Letrozole     Afatinib 40 mg With Letrozole     Afatinib 30 mg With Letrozole     Total  
Number of Participants  
[units: participants]
  7     13     8     28  
Age  
[units: years]
Mean ± Standard Deviation
  63.0  ± 14.7     64.8  ± 7.2     58.5  ± 9.0     62.5  ± 10.0  
Gender  
[units: participants]
       
Female     7     13     8     28  
Male     0     0     0     0  



  Outcome Measures
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1.  Primary:   Percentage of Progression Free Participants After 16 Weeks of Treatment   [ Time Frame: 16 weeks ]

2.  Secondary:   Number of Participants With Confirmed Objective Response (OR)   [ Time Frame: Baseline till progression ]

3.  Secondary:   Number of Participants With Clinical Benefit (CB)   [ Time Frame: 16 weeks and 24 weeks ]

4.  Secondary:   Time to RECIST Tumour Reponse   [ Time Frame: Baseline till progression ]

5.  Secondary:   Duration of Confirmed OR   [ Time Frame: First occurence or OR till progression or death ]

6.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: Baseline till progression, death or data cut-off (04 Jan 2010) ]

7.  Secondary:   Overall Survival (OS)   [ Time Frame: Baseline till progression, death or data cut-off ]

8.  Secondary:   Area Under Curve of Afatinib Over a Uniform Dosing Interval Tau at Steady State (AUCtau,ss)   [ Time Frame: 0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing ]

9.  Secondary:   Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss)   [ Time Frame: 0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing ]

10.  Secondary:   Pre-dose Concentration of Afatinib in Plasma at Steady State on Day 57 (Cpre,ss,57)   [ Time Frame: Day 57 ]

11.  Secondary:   Pre-dose Concentration of Afatinib in Plasma at Steady Stateon Day 85 (Cpre,ss,85)   [ Time Frame: Day 85 ]

12.  Secondary:   Time From Dosing to the Maximum Concentration of Afatinib in Plasma at Steady State (Tmax,ss)   [ Time Frame: 0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing ]

13.  Secondary:   Area Under Curve of Letrozole Over a Uniform Dosing Interval Tau at Steady State (AUCtau,ss)   [ Time Frame: 0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing ]

14.  Secondary:   Maximum Concentration of Letrozole in Plasma at Steady State (Cmax,ss)   [ Time Frame: 0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing ]

15.  Secondary:   Time From Dosing to the Maximum Concentration of Letrozole in Plasma at Steady State (Tmax,ss)   [ Time Frame: 0.05 hours (h) before dosing and 2h, 4h, 6h, 8h and 24h after dosing ]

16.  Secondary:   Change From Baseline in Ca15.3   [ Time Frame: baseline and day 29 ]

17.  Secondary:   Best Change From Baseline in ECOG Performance Status   [ Time Frame: baseline till end of treatment ]


  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: 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: NCT00708214     History of Changes
Other Study ID Numbers: 1200.5, 2006-002814-37
Study First Received: June 30, 2008
Results First Received: August 8, 2013
Last Updated: December 5, 2013
Health Authority: France: Agence Française de Sécurité Sanitaire des Produits de Santé