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

Part of paid clinical trials in Bakersfield, California.

Sponsor
Boehringer Ingelheim
Study ID
NCT01441596
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vinorelbine — DRUG
    Vinorelbine 25 mg/m² on days 1, 8, 15 in a 3-weekly course
  • Investigator's choice of treatment — DRUG
    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 — DRUG
    Afatinib monotherapy:once daily, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
  • afatinib — DRUG
    Afatinib monotherapy:once daily, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.

Study Details

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 Dates

Start date
Oct 31, 2011
Status verified
Aug 2015
Primary completion
Feb 28, 2014
Completion
Aug 31, 2014

Study Design

Enrollment
121 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Patient Benefit Rate at 12 Weeks [ Time Frame: 12 weeks from randomisation ]

Locations (6)

FacilityCityStateZIPSite coordinators
1200.67.10106 Boehringer Ingelheim Investigational SiteBakersfieldCalifornia--
1200.67.10105 Boehringer Ingelheim Investigational SiteFullertonCalifornia--
1200.67.10001 Boehringer Ingelheim Investigational SiteLos AngelesCalifornia--
1200.67.10108 Boehringer Ingelheim Investigational SiteSanta BarbaraCalifornia--
1200.67.10003 Boehringer Ingelheim Investigational SiteLake SuccessNew York--
1200.67.10004 Boehringer Ingelheim Investigational SiteColumbusOhio--

Find similar trials in Bakersfield, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
1200.67.10106 Boehringer Ingelheim Investigational Site· Bakersfield, CA1200.67.10105 Boehringer Ingelheim Investigational Site· Fullerton, CA1200.67.10001 Boehringer Ingelheim Investigational Site· Los Angeles, CA1200.67.10108 Boehringer Ingelheim Investigational Site· Santa Barbara, CA1200.67.10003 Boehringer Ingelheim Investigational Site· Lake Success, NY1200.67.10004 Boehringer Ingelheim Investigational Site· Columbus, OH

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