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
NCT ID: NCT01441596
Last Updated: 2015-09-07
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
121 participants
INTERVENTIONAL
2011-10-31
2014-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment
NCT01125566
A Study Evaluating the Efficacy and Safety of Lapatinib + Vinorelbine in ErbB2 Positive Metastatic Breast Cancer Patients
NCT01161368
Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.
NCT02000622
To Study Clinical Effectiveness and Safety of Olaparib Monotherapy in Metastatic Breast Cancer Patients.
NCT03286842
A Study of Herceptin (Trastuzumab) in Combination With Whole Brain Radiotherapy in Patients With HER-2 Positive Breast Cancer
NCT01363986
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
arm A: Afatinib monotherapy
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.
afatinib
Afatinib monotherapy:once daily, 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 40 mg per day, continuous treatment, in combination with vinorelbine Vinorelbine 25 mg/m² on days 1, 8, 15 in a 3-weekly course.
Vinorelbine
Vinorelbine 25 mg/m² on days 1, 8, 15 in a 3-weekly course
afatinib
Afatinib monotherapy:once daily, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
arm C: investigator's choice of treatmen
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vinorelbine
Vinorelbine 25 mg/m² on days 1, 8, 15 in a 3-weekly course
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.
afatinib
Afatinib monotherapy:once daily, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
afatinib
Afatinib monotherapy:once daily, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. at least one measurable and progressive lesion in the brain (=10 mm on T1-weighted, gadolinium-enhanced Magnetic Resonance Imaging). Measurable or non measurable extracranial metastases allowed.
3. previous treatment with HER2 inhibitors to be discontinued prior to first study treatment administration (at least 14 days for trastuzumab and other antibodies, at least 7 days for lapatinib).
4. previous chemotherapy and hormonal therapy (adjuvant and metastatic regimens) allowed, but chemotherapy must have been discontinued at least 14 days and hormonal therapy at least 7 days prior to first study treatment administration.
5. Patients must have recovered to baseline condition or to Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 grade = 1 from any acute CTCAE v. 3.0 grade =2 side effects of previous treatments.
6. prior surgery, whole brain radiotherapy or stereotactic radiosurgery allowed provided that there is unequivocal evidence of one or more new and/or progressive brain metastases after completion of whole brain radiotherapy or stereotactic radiosurgery.
Exclusion Criteria
2. Any other current malignancy or malignancy diagnosed within the past five (5) years (other than bilateral primary breast cancer, metastases to the contralateral breast, non-melanomatous skin cancer and in situ cervical cancer).
3. Significant chronic or recent acute gastrointestinal disorders with diarrhoea as a major symptom e.g. Crohn's disease, malabsorption or Common Terminology Criteria (CTC) grade =2 diarrhoea of any aetiology.
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boehringer Ingelheim
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
1200.67.10106 Boehringer Ingelheim Investigational Site
Bakersfield, California, United States
1200.67.10105 Boehringer Ingelheim Investigational Site
Fullerton, California, United States
1200.67.10001 Boehringer Ingelheim Investigational Site
Los Angeles, 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
1200.67.33009 Boehringer Ingelheim Investigational Site
Caen, , France
1200.67.33010 Boehringer Ingelheim Investigational Site
Clermont-Ferrand, , France
1200.67.33008 Boehringer Ingelheim Investigational Site
Lille, , France
1200.67.33001 Boehringer Ingelheim Investigational Site
Lyon, , France
1200.67.33004 Boehringer Ingelheim Investigational Site
Marseille, , France
1200.67.33011 Boehringer Ingelheim Investigational Site
Nice, , France
1200.67.33002 Boehringer Ingelheim Investigational Site
Paris, , France
1200.67.33003 Boehringer Ingelheim Investigational Site
Paris, , France
1200.67.33012 Boehringer Ingelheim Investigational Site
Saint-Cloud, , France
1200.67.33005 Boehringer Ingelheim Investigational Site
Saint-Herblain, , France
1200.67.49002 Boehringer Ingelheim Investigational Site
Erlangen, , Germany
1200.67.49008 Boehringer Ingelheim Investigational Site
Essen, , Germany
1200.67.49005 Boehringer Ingelheim Investigational Site
Hanover, , 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, , South Korea
1200.67.82002 Boehringer Ingelheim Investigational Site
Seoul, , South Korea
1200.67.82003 Boehringer Ingelheim Investigational Site
Seoul, , South Korea
1200.67.82004 Boehringer Ingelheim Investigational Site
Seoul, , South Korea
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Cortes J, Dieras V, Ro J, Barriere J, Bachelot T, Hurvitz S, Le Rhun E, Espie M, Kim SB, Schneeweiss A, Sohn JH, Nabholtz JM, Kellokumpu-Lehtinen PL, Taguchi J, Piacentini F, Ciruelos E, Bono P, Ould-Kaci M, Roux F, Joensuu H. Afatinib alone or afatinib plus vinorelbine versus investigator's choice of treatment for HER2-positive breast cancer with progressive brain metastases after trastuzumab, lapatinib, or both (LUX-Breast 3): a randomised, open-label, multicentre, phase 2 trial. Lancet Oncol. 2015 Dec;16(16):1700-10. doi: 10.1016/S1470-2045(15)00373-3. Epub 2015 Nov 17.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2010-021415-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1200.67
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.