Lux-Breast 3; Afatinib Alone or in Combination With Vinorelbine in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer Suffering From Brain Metastases
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| ClinicalTrials.gov Identifier: NCT01441596 |
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Recruitment Status :
Completed
First Posted : September 27, 2011
Results First Posted : February 25, 2015
Last Update Posted : September 7, 2015
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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 |
| Conditions |
Breast Neoplasms Neoplasm Metastasis |
| Interventions |
Drug: Vinorelbine Drug: Investigator's choice of treatment Drug: afatinib |
| Enrollment | 121 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | Afatinib Mono | Afatinib+Vino | Investigator's Choice |
|---|---|---|---|
 Arm/Group Description |
Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg. | Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course. | Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines. |
| Period Title: Overall Study | |||
| Started | 40 | 38 | 43 |
| Completed | 36 | 35 | 39 |
| Not Completed | 4 | 3 | 4 |
| Reason Not Completed | |||
| Other reason not defined below | 0 | 2 | 1 |
| Withdrawal by Subject | 4 | 0 | 2 |
| Not treated | 0 | 1 | 1 |
Baseline Characteristics
| Arm/Group Title | Afatinib Mono | Afatinib+Vino | Investigator's Choice | Total | |
|---|---|---|---|---|---|
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Arm/Group Description |
Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg. | Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course. | Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 40 | 38 | 43 | 121 | |
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Baseline Analysis Population Description |
Randomised Set (RS): includes all randomised patients, whether treated or not.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 40 participants | 38 participants | 43 participants | 121 participants | |
| 51.5 (10.3) | 51.2 (10.6) | 52.6 (10.3) | 51.8 (10.3) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 40 participants | 38 participants | 43 participants | 121 participants | |
| Female |
40 100.0%
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38 100.0%
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43 100.0%
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121 100.0%
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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
[Not Specified]
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.
Other - Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Results Point of Contact
| Name/Title: | Boehringer Ingelheim Call Center |
| Organization: | Boehringer Ingelheim |
| Phone: | 1-800-243-0127 |
| EMail: | clintriage.rdg@boehringer-ingelheim.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT01441596 |
| Other Study ID Numbers: |
1200.67 2010-021415-16 ( EudraCT Number: EudraCT ) |
| First Submitted: | September 26, 2011 |
| First Posted: | September 27, 2011 |
| Results First Submitted: | February 10, 2015 |
| Results First Posted: | February 25, 2015 |
| Last Update Posted: | September 7, 2015 |