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
Overview
- Phase
- Phase 2
- Intervention
- afatinib
- Conditions
- Breast Neoplasms
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 121
- Locations
- 40
- Primary Endpoint
- Patient Benefit Rate at 12 Weeks
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: afatinib
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.
Intervention: Vinorelbine
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.
Intervention: afatinib
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.
Intervention: Investigator's choice of treatment
Outcomes
Primary Outcomes
Patient Benefit Rate at 12 Weeks
Time Frame: 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 Outcomes
- Progression-Free Survival(From first drug administration until 28 days after end of treatment, up to 805 days)
- Overall Survival(From first drug administration until 28 days after end of treatment, up to 805 days)