LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Boehringer Ingelheim
Study ID
NCT01125566
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • BIBW 2992 — DRUG
    patients receive BIBW 2992 tablets once daily and can reduce dose for adverse event management
  • trastuzumab — DRUG
    patients receive trastuzumab 2mg/kg intravenously every week
  • vinorelbine — DRUG
    patients receive vinorelbine 25mg/m² intravenously every week
  • vinorelbine — DRUG
    patients receive vinorelbine 25mg/m² intravenously every week

Study Details

To investigate the efficacy and safety of BIBW 2992 in combination with vinorelbine i.v. chemotherapy as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed one prior trastuzumab (Herceptin®) treatment

Key Dates

Start date
Jun 22, 2010
Status verified
Jul 2019
Primary completion
Jun 8, 2013
Completion
Jul 6, 2018

Study Design

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

Arms

  • Active Comparator: Arm B: trastuzumab with vinorelbine
    patients receive weekly intravenous infusion of trastuzumab and vinorelbine
  • Experimental: Arm A: BIBW 2992 with vinorelbine
    patients receive BIBW 2992 tablets once daily combined with weekly intravenous infusion of vinorelbine

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: From randomization (07Sep2010) until disease progression, death or data cut-off (08Jun2013); Up to 34 months ]

Locations (14)

FacilityCityStateZIPSite coordinators
Achieve Clinical Research, LLCBirminghamAlabama35216-
Ironwood Cancer and Research CentersChandlerArizona85224-
Robert A. Moss MD, FACP, IncFountain ValleyCalifornia92708-
St. Jude Heritage HealthcareFullertonCalifornia92835-
University of CaliforniaLos AngelesCalifornia90095-
Cancer Care Associates Medical Group, IncRedondo BeachCalifornia90277-
Santa Barbara Hematology Oncology Medical Group, IncSanta BarbaraCalifornia93105-
Central Coast Medical Oncology CorporationSanta MariaCalifornia93454-
North Shore Cancer Research AssociatesSkokieIllinois60076-
Cedar Valley Cancer CenterWaterlooIowa50701-
Pro Health Care AssociatedLake SuccessNew York11042-
Hope Women's Cancer CenterAshevilleNorth Carolina28806-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
Utah Cancer Specialists Cancer CenterSalt Lake CityUtah84106-

Find similar trials in Birmingham, AL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Achieve Clinical Research, LLC· Birmingham, ALIronwood Cancer and Research Centers· Chandler, AZRobert A. Moss MD, FACP, Inc· Fountain Valley, CASt. Jude Heritage Healthcare· Fullerton, CAUniversity of California· Los Angeles, CACancer Care Associates Medical Group, Inc· Redondo Beach, CA

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