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

Phase 2

Completed

Interventions: Drug: Investigator's choice of treatment
Drug: afatinib
Drug: Vinorelbine

Brief Summary: The aim of this study is to investigate the efficacy and safety of afatinib alone or in combination with vinorelbine, as treatment in patients with HER2-overexpressing metastatic breast cancer, who have progressive brain lesions after trastuzumab and/or lapatinib based therapy

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
arm C: investigator's choice of treatmen	Investigator's choice of treatment	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.
arm A: Afatinib monotherapy	afatinib	Afatinib monotherapy: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
arm B: Afatinib in combination with vino	afatinib	Afatinib 40 mg per day, continuous treatment, in combination with vinorelbine Vinorelbine 25 mg/mÂ² on days 1, 8, 15 in a 3-weekly course.
arm B: Afatinib in combination with vino	Vinorelbine	Afatinib 40 mg per day, continuous treatment, in combination with vinorelbine Vinorelbine 25 mg/mÂ² on days 1, 8, 15 in a 3-weekly course.

Primary Outcome Measures

Name	Time	Method
Patient Benefit Rate at 12 Weeks	12 weeks from randomisation	Percentage of patients with patient benefit at week 12. Patient benefit was defined by the absence of central nervous system (CNS) disease progression according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 in addition to no tumour-related worsening of the neurological signs and symptoms (NSS), no tumour-related increase in corticosteroid dosage and no progression of extra CNS disease according to RECIST 1.1

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival	From first drug administration until 28 days after end of treatment, up to 805 days	Progression-Free Survival is defined as the time from the date of randomisation to the date of disease progression or death whichever came first. Disease progression was defined as either disease progression in CNS lesions (including worsening in NSS and use of corticosteroid) or disease progression in extra-CNS lesions according to RECIST 1.1.
Overall Survival	From first drug administration until 28 days after end of treatment, up to 805 days	Overall Survival is defined as time from randomisation to the date of death from any cause.

Locations (40): 1200.67.10106 Boehringer Ingelheim Investigational Site
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Bakersfield, California, United States
1200.67.10105 Boehringer Ingelheim Investigational Site
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Fullerton, California, United States
1200.67.10001 Boehringer Ingelheim Investigational Site
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Los Angeles, California, United States
1200.67.10108 Boehringer Ingelheim Investigational Site
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Santa Barbara, California, United States
1200.67.10003 Boehringer Ingelheim Investigational Site
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Lake Success, New York, United States
1200.67.10004 Boehringer Ingelheim Investigational Site
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Columbus, Ohio, United States
1200.67.11004 Boehringer Ingelheim Investigational Site
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Toronto, Ontario, Canada
1200.67.11003 Boehringer Ingelheim Investigational Site
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Greenfield Park, Quebec, Canada
1200.67.11002 Boehringer Ingelheim Investigational Site
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Montreal, Quebec, Canada
1200.67.35801 Boehringer Ingelheim Investigational Site
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Helsinki, Finland
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1200.67.10106 Boehringer Ingelheim Investigational Site
🇺🇸Bakersfield, California, United States