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

• Conditions: Breast Neoplasms; Neoplasm Metastasis
• Interventions: Drug: Investigator's choice of treatment; Drug: afatinib; Drug: Vinorelbine

• Registration Number: NCT01441596
• Lead Sponsor: Boehringer Ingelheim

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-26
• Study First Submitted QC: 2011-09-26
• Study First Posted: 2011-09-27
• Study Start: 2011-10
• Primary Completion: 2014-02
• Study Completion: 2014-08
• Results First Submitted: 2015-02-10
• Results First Submitted QC: 2015-02-10
• Results First Posted: 2015-02-25
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-25
• Last Update Posted: 2015-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 121

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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/m² 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/m² 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.

Trial Locations

Locations (40)

1200.67.82002 Boehringer Ingelheim Investigational Site; 🇰🇷 Seoul, Korea, Republic of

1200.67.10105 Boehringer Ingelheim Investigational Site; 🇺🇸 Fullerton, California, United States

1200.67.10108 Boehringer Ingelheim Investigational Site; 🇺🇸 Santa Barbara, California, United States

1200.67.10003 Boehringer Ingelheim Investigational Site; 🇺🇸 Lake Success, New York, United States

1200.67.10004 Boehringer Ingelheim Investigational Site; 🇺🇸 Columbus, Ohio, United States

1200.67.11004 Boehringer Ingelheim Investigational Site; 🇨🇦 Toronto, Ontario, Canada

1200.67.11003 Boehringer Ingelheim Investigational Site; 🇨🇦 Greenfield Park, Quebec, Canada

1200.67.11002 Boehringer Ingelheim Investigational Site; 🇨🇦 Montreal, Quebec, Canada

1200.67.35801 Boehringer Ingelheim Investigational Site; 🇫🇮 Helsinki, Finland

1200.67.35802 Boehringer Ingelheim Investigational Site; 🇫🇮 Tampere, Finland

1200.67.35803 Boehringer Ingelheim Investigational Site; 🇫🇮 Turku, Finland

1200.67.33010 Boehringer Ingelheim Investigational Site; 🇫🇷 Clermont-Ferrand cedex 1, France

1200.67.33009 Boehringer Ingelheim Investigational Site; 🇫🇷 Caen Cedex, France

1200.67.33008 Boehringer Ingelheim Investigational Site; 🇫🇷 Lille Cedex, France

1200.67.33001 Boehringer Ingelheim Investigational Site; 🇫🇷 Lyon Cedex 08, France

1200.67.33004 Boehringer Ingelheim Investigational Site; 🇫🇷 Marseille Cedex 09, France

1200.67.33011 Boehringer Ingelheim Investigational Site; 🇫🇷 Nice Cedex 02, France

1200.67.33002 Boehringer Ingelheim Investigational Site; 🇫🇷 Paris Cedex 05, France

1200.67.33003 Boehringer Ingelheim Investigational Site; 🇫🇷 Paris, France

1200.67.49002 Boehringer Ingelheim Investigational Site; 🇩🇪 Erlangen, Germany

1200.67.33012 Boehringer Ingelheim Investigational Site; 🇫🇷 Saint Cloud, France

1200.67.33005 Boehringer Ingelheim Investigational Site; 🇫🇷 Saint Herblain Cedex, France

1200.67.49008 Boehringer Ingelheim Investigational Site; 🇩🇪 Essen, Germany

1200.67.49005 Boehringer Ingelheim Investigational Site; 🇩🇪 Hannover, Germany

1200.67.49006 Boehringer Ingelheim Investigational Site; 🇩🇪 Heidelberg, Germany

1200.67.49007 Boehringer Ingelheim Investigational Site; 🇩🇪 München, Germany

1200.67.49003 Boehringer Ingelheim Investigational Site; 🇩🇪 Oldenburg, Germany

1200.67.49004 Boehringer Ingelheim Investigational Site; 🇩🇪 Tübingen, Germany

1200.67.39001 Boehringer Ingelheim Investigational Site; 🇮🇹 Modena, Italy

1200.67.39002 Boehringer Ingelheim Investigational Site; 🇮🇹 Reggio Emilia, Italy

1200.67.82001 Boehringer Ingelheim Investigational Site; 🇰🇷 Goyang, Korea, Republic of

1200.67.82003 Boehringer Ingelheim Investigational Site; 🇰🇷 Seoul, Korea, Republic of

1200.67.82004 Boehringer Ingelheim Investigational Site; 🇰🇷 Seoul, Korea, Republic of

1200.67.34002 Boehringer Ingelheim Investigational Site; 🇪🇸 Barcelona, Spain

1200.67.34006 Boehringer Ingelheim Investigational Site; 🇪🇸 Córdoba, Spain

1200.67.34005 Boehringer Ingelheim Investigational Site; 🇪🇸 L'Hospitalet de Llobregat, Spain

1200.67.34003 Boehringer Ingelheim Investigational Site; 🇪🇸 Madrid, Spain

1200.67.34004 Boehringer Ingelheim Investigational Site; 🇪🇸 Valencia, Spain

1200.67.10106 Boehringer Ingelheim Investigational Site; 🇺🇸 Bakersfield, California, United States

1200.67.10001 Boehringer Ingelheim Investigational Site; 🇺🇸 Los Angeles, California, United States