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

Completed · Phase 2

Conditions studied: Breast Neoplasms, Neoplasm Metastasis

In brief

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

Key facts

Study ID

NCT01441596

Run by

Boehringer Ingelheim

People needed

121

Starts

2011-10-01

Expected to finish

2014-08-01

Last updated by the study team

2015-09-07

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• patients with HER2 positive breast cancer with a documented central nervous system (CNS) recurrence/progression (by imaging) during or after a HER2 inhibitor (Trastuzumab and/or Lapatinib) based therapy (no leptomeningeal carcinomatosis as the only site of CNS metastases)
• 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.
• 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).
• 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.
• 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.
• 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.

You may not qualify if…

• Prior treatment with HER2- tyrosine kinase inhibitor other than lapatinib
• 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).
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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