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

Completed · Phase 3

Conditions studied: Breast Neoplasms

In brief

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 facts

Study ID

NCT01125566

Run by

Boehringer Ingelheim

People needed

508

Starts

2010-06-22

Expected to finish

2018-07-06

Last updated by the study team

2019-07-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed diagnosis of HER2-overexpression breast cancer
• Stage IV metastatic disease
• Must have progressed on one prior trastuzumab treatment
• no more than one prior trastuzumab based therapy regimen (either adjuvant or first-line)
• Must have received anthracycline and/or taxane based chemotherapy for adjuvant treatment of breast cancer or first-line treatment of metastatic breast cancer
• Must have (archived) tumour tissue sample available for central re-assessment of HER2-status
• At least one measurable lesion according to RECIST 1.1.
• Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 .

You may not qualify if…

• Prior treatment with Epidermal Growth Factor Receptor/Human Epidermal Growth Factor Receptor(EGFR/HER2)-targeted small molecules or antibodies other than trastuzumab
• Prior treatment with vinorelbine
• Known pre-existing interstitial lung disease
• Active brain metastases
• History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to randomisation.
• Cardiac left ventricular function with resting ejection fraction of less than 50%.
• Patients unable to comply with the protocol.
• Any contraindications for therapy with vinorelbine or trastuzumab.
• Known hypersensitivity to BIBW 2992 or the excipients of any of the trial drugs.
• Use of any investigational drug within 4 weeks of randomisation.
• Inadequate hepatic, renal and haematologic organ function

Where it is running

• Ironwood Cancer and Research Centers — Chandler, Arizona, United States
• Robert A. Moss MD, FACP, Inc — Fountain Valley, California, United States
• St. Jude Heritage Healthcare — Fullerton, California, United States
• University of California — Los Angeles, California, United States
• Cancer Care Associates Medical Group, Inc — Redondo Beach, California, United States
• Santa Barbara Hematology Oncology Medical Group, Inc — Santa Barbara, California, United States
• Central Coast Medical Oncology Corporation — Santa Maria, California, United States
• North Shore Cancer Research Associates — Skokie, Illinois, United States
• Cedar Valley Cancer Center — Waterloo, Iowa, United States
• Pro Health Care Associated — Lake Success, New York, United States
• Hope Women's Cancer Center — Asheville, North Carolina, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Utah Cancer Specialists Cancer Center — Salt Lake City, Utah, United States
• Instituto Medico de Asistencia e Investigaciones S. A. — Buenos Aires, Argentina
• Hospital Britanico — Capital Federal, Argentina
• Sanatorio de la Provodencia — Ciudad Autonoma de Bs As, Argentina
• Sanatorio Parque — Rosario, Argentina
• Port Macquarie Base Hospital (PMBH) — Port Macquarie, New South Wales, Australia
• St Vincent's Hospital Melbourne — Fitzroy, Victoria, Australia
• Peninsula Haematology & Oncology — Frankston, Victoria, Australia
• Maroondah Hospital — Ringwood East, Victoria, Australia
• Mount Medical Centre — Perth, Western Australia, Australia
• Ordensklinikum Linz GmbH - Barmherzige Schwestern — Linz, Austria
• Kaiser Franz Josef Spital Vienna — Vienna, Austria
• Achieve Clinical Research, LLC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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