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



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/2/2018
Start Date:June 22, 2010
End Date:June 7, 2018

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LUX-Breast 1; An Open Label, Randomised Phase III Trial of BIBW 2992 and Vinorelbine Versus Trastuzumab and Vinorelbine in Patients With Metastatic HER2-overexpressing Breast Cancer Failing One Prior Trastuzumab Treatment

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


Inclusion criteria:

- 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.

- ECOG score of 0 or 1 .

Exclusion criteria:

- Prior treatment with 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
We found this trial at
15
sites
2017 Canyon Road, Suite 41
Birmingham, Alabama 35216
(205) 757-8208
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220 S Palisade Dr # 204
Santa Maria, California 93454
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Asheville, North Carolina 28806
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3150 Combatientes de Malvinas
Buenos Aires, C1427
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Chandler, Arizona 85224
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Fountain Valley, California 92708
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Fullerton, California 92835
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1 Dakota Drive
Lake Success, New York 11042
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Los Angeles, California 90095
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
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Redondo Beach, California 90277
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3838 South 700 East
Salt Lake City, Utah 84106
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9600 Gross Point Road
Skokie, Illinois 60076
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3530 West 4th Street
Waterloo, Iowa 50701
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