6 Weeks Treatment of Locally Advanced Breast Cancer With BIBW 2992 (Afatinib) or Lapatinib or Trastuzumab
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| ClinicalTrials.gov Identifier: NCT00826267 |
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Recruitment Status :
Completed
First Posted : January 22, 2009
Results First Posted : October 17, 2013
Last Update Posted : December 31, 2013
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Sponsor:
Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Condition |
Breast Neoplasms |
| Interventions |
Drug: lapatinib Drug: BIBW 2992 Drug: trastuzumab |
| Enrollment | 29 |
Participant Flow
| Recruitment Details | Because of slow enrollment and a high screen-failure rate, recruitment became a challenge and the sponsor chose to terminate the trial prior to reaching the target enrollment of 120 patients. |
| Pre-assignment Details |
| Arm/Group Title | Afatinib 50 mg | Lapatinib 1500 mg | Trastuzumab |
|---|---|---|---|
 Arm/Group Description |
Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial. | Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial. | Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses. |
| Period Title: Overall Study | |||
| Started | 10 | 8 | 11 |
| Completed | 9 | 8 | 11 |
| Not Completed | 1 | 0 | 0 |
| Reason Not Completed | |||
| Other Adverse Event | 1 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Afatinib 50 mg | Lapatinib 1500 mg | Trastuzumab | Total | |
|---|---|---|---|---|---|
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Arm/Group Description |
Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial. | Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial. | Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 10 | 8 | 11 | 29 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 10 participants | 8 participants | 11 participants | 29 participants | |
| 50.7 (8.7) | 58.5 (13.4) | 44.1 (12.2) | 50.3 (12.5) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 10 participants | 8 participants | 11 participants | 29 participants | |
| Female |
10 100.0%
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8 100.0%
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11 100.0%
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29 100.0%
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| Male |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
Because of slow enrollment and a high screen-failure rate, recruitment became a challenge and the sponsor chose to terminate the trial prior to reaching the target enrollment of 120 pat. Small number of subjects lead to some shortcomings in analyses.
More Information
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.
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Results Point of Contact
| Name/Title: | Boehringer Ingelheim Call Center |
| Organization: | Boehringer Ingelheim Pharmaceuticals |
| Phone: | 1-800-243-0127 |
| EMail: | clintriage.rdg@boehringer-ingelheim.com |
| Responsible Party: | Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT00826267 |
| Other Study ID Numbers: |
1200.44 |
| First Submitted: | January 20, 2009 |
| First Posted: | January 22, 2009 |
| Results First Submitted: | August 8, 2013 |
| Results First Posted: | October 17, 2013 |
| Last Update Posted: | December 31, 2013 |