Status:
COMPLETED
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
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Breast Neoplasms
Neoplasm Metastasis
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 ha...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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.
- Exclusion criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT01441596
Start Date
October 1 2011
End Date
August 1 2014
Last Update
September 7 2015
Active Locations (40)
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1
1200.67.10106 Boehringer Ingelheim Investigational Site
Bakersfield, California, United States
2
1200.67.10105 Boehringer Ingelheim Investigational Site
Fullerton, California, United States
3
1200.67.10001 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
4
1200.67.10108 Boehringer Ingelheim Investigational Site
Santa Barbara, California, United States