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Lux-Breast 3; Randomised Phase II Study of Afatinib Alone or in Combination With Vinorelbine Versus Investigator's Choice of Treatment in Patients With HER2 Positive Breast Cancer With Progressive Brain Metastases After Trastuzumab and/or Lapatinib Based Therapy
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
Details
| Lead sponsor | Boehringer Ingelheim |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 121 |
| Start date | 2011-10 |
| Completion | 2014-08 |
Conditions
- Breast Neoplasms
- Neoplasm Metastasis
Interventions
- Vinorelbine
- Investigator's choice of treatment
- afatinib
- afatinib
Primary outcomes
- 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
Countries
United States, Canada, Finland, France, Germany, Italy, South Korea, Spain