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

This study is ongoing, but not recruiting participants.
ClinicalTrials.gov Identifier:
First Posted: May 18, 2010
Last Update Posted: September 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
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

Condition Intervention Phase
Breast Neoplasms Drug: BIBW 2992 Drug: trastuzumab Drug: vinorelbine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Boehringer Ingelheim:

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

    PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by investigator according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1).

    Only data collected until the cut-off date for RECIST 1.1 based endpoints (08Jun2013) were considered.

    Progression of disease was determined if at least 1 of the following criteria applied:

    • At least a 20% increase in the sum of the diameters (SoD) of target lesions taking as reference the smallest SoD recorded since the treatment started, together with an absolute increase in the SoD of at least 5 mm
    • Appearance of 1 or more new lesions
    • Unequivocal progression of existing non-target lesions

Secondary Outcome Measures:
  • Objective Response (OR) [ Time Frame: Post baseline tumour-imaging was performed at Week 8, 16, 24, 32, 40, 48, 56 and then every 12 weeks (Up to 34 months) ]

    OR is defined as complete response (CR) and partial response (PR). Assessed by investigator according to RECIST 1.1.

    Only data collected until the cut-off date 08Jun2013 were considered. Complete Response (CR) for target lesions (TL): Disappearance of all target lesions.

    Complete Response (CR) for non-target lesions (NTL): Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (<10mm short axis)

    Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.

    Other factors which add to the overall response of an imaging timepoint as PR are as below:-

    • CR in TL, but non-CR/Non-PD in NTL leads to PR
    • CR in TL, but not evaluated NTL leads to PR
    • PR in TL, but non-PD NTL or not all evaluated NTL leads to PR

  • Best RECIST Assessment [ Time Frame: Post baseline tumour-imaging was performed at Week 8, 16, 24, 32, 40, 48, 56 and then every 12 weeks (Data collected until cut-off date 08Jun2013; Up to 34 months) ]

    Best RECIST assessment is defined as CR, PR, stable disease (SD), PD or not evaluable by investigator (RECIST version 1.1).

    CR for target lesions (TL): Disappearance of all target lesions.

    CR for non-target lesions (NTL): Disappearance of all non-target lesions and normalization of tumour marker level. All lymph nodes must be non-pathological in size (<10mm short axis).

    PR: At least a 30% decrease in the sum of diameters (SoD) of target lesions taking as reference the baseline sum diameters.

    SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as references the smallest SoD while on study.

    PD: At least a 20% increase in the SoD of target lesions, taking as references the smallest sum on study (this includes the baseline sum if that is the smallest on study). Also, the sum must also demonstrate an absolute increase of a least 5mm. Appearance of one or more new lesions.

  • Overall Survival (OS) [ Time Frame: From randomisation to data cut-off (03Sep2013); Up to 37 months. ]

    OS is defined as time from randomisation to death irrespective of the cause of the death.

    For patients who had not died up to the cut-off date (03Sep2013), the date they were last known to be alive was derived from the patient status records, the trial completion record, radiological imaging assessments, the study treatment termination record, and the randomisation date.

Enrollment: 508
Actual Study Start Date: June 22, 2010
Estimated Study Completion Date: December 29, 2017
Primary Completion Date: June 8, 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm B: trastuzumab with vinorelbine
patients receive weekly intravenous infusion of trastuzumab and vinorelbine
Drug: trastuzumab
patients receive trastuzumab 2mg/kg intravenously every week
Drug: vinorelbine
patients receive vinorelbine 25mg/m² intravenously every week
Experimental: Arm A: BIBW 2992 with vinorelbine
patients receive BIBW 2992 tablets once daily combined with weekly intravenous infusion of vinorelbine
Drug: BIBW 2992
patients receive BIBW 2992 tablets once daily and can reduce dose for adverse event management
Drug: vinorelbine
patients receive vinorelbine 25mg/m² intravenously every week


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01125566

  Hide Study Locations
United States, California
St. Jude Heritage Healthcare
Fullerton, California, United States, 92835
University of California
Los Angeles, California, United States, 90095
Cancer Care Associates Medical Group, Inc
Redondo Beach, California, United States, 90277
Santa Barbara Hematology Oncology Medical Group, Inc
Santa Barbara, California, United States, 93105
Central Coast Medical Oncology Corporation
Santa Maria, California, United States, 93454
United States, Utah
Utah Cancer Specialists Cancer Center
Salt Lake City, Utah, United States, 84106
Australia, Victoria
Maroondah Hospital
Ringwood East, Victoria, Australia, 3135
N. N. Alexandrov National Cancer Center of Belarus
Minsk region, Belarus, 223040
Public Health Inst. Minsk City Clinical Oncology Dispensary
Minsk, Belarus, 220013
Vitebsk Regional Clinical Oncology Dispensary
Vitebsk, Belarus, 210603
Brussels - HOSP Jules Bordet
Bruxelles, Belgium, 1000
Edegem - UNIV UZ Antwerpen
Edegem, Belgium, 2650
Associacao Hospital de Caridade de Ijui
Ijui, Brazil, 98700-000
Associação Hospitalar Moinhos de Vento
Porto Alegre, Brazil, 90035-001
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Brazil, 90050-170
Centro de Novos Tratamentos CliniOnco
Porto Alegre, Brazil, 90430-090
Instituto Nacional do Câncer - INCA
Rio de Janeiro, Brazil, 20560-120
Faculdade de Medicina do ABC
Santo André, Brazil, 09060-650
Centro de Referência da Saude da Mulher-Hosp Perola Byington
Sao Paulo, Brazil, 01317-000
Canada, British Columbia
BC Cancer Agency - Vancouver
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Migration Data
Hopital Notre-Dame du CHUM
Montreal, Migration Data, Canada, H2L 4M1
Hop. Du St. Sacrement
Quebec, Migration Data, Canada, G1S 4L8
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Cancer Hospital of Chinese Academy of Medical Science
Beijing, China, 100021
Peking Union Medical College Hospital
Beijing, China, 100032
Peking University People's Hospital
Beijing, China, 100044
307 Hospital of PLA
Beijing, China, 100071
Chinese PLA General Hospital
Beijing, China, 100853
First Hospital of Jilin University
Changchun, China, 130021
West China Hospital
Chengdu, China, 610041
Fujian Provincial Tumor Hospital
Fuzhou, China, 350014
Sun Yat-Sen University Cancer Center
Guangzhou, China, 510060
Guangdong General Hospital
Guangzhou, China, 510080
NanFang Hosptial
Guangzhou, China, 510515
The Third Affiliated Hospital of Harbin Medical University
Haerbin, China, 150081
1st Affiliated Hosp of College of Medicine, Zhejiang Uni
Hangzhou, China, 310009
Zhejiang Cancer Hospital
Hangzhou, China, 310022
Qilu Hospital, Shangdong University
Jinan, China, 250012
the 81th Hospital of PLA
Nanjing, China, 210002
Shanghai Ruijin Hospital
Shanghai, China, 200025
Fudan University Shanghai Cancer Center
Shanghai, China, 200033
Tianjin Medical University Cancer Institute and Hospital
Tianjin, China, 300060
Wuhan Union Hospital
Wuhan, China, 430022
El Manial Specialized Hospital
Cairo, Egypt, 11553
HOP Amiens Sud, Onco, Amiens
Amiens Cedex 1, France, 80054
CTR Eugène Marquis, Onco, Rennes
Rennes Cedex, France, 35042
Kliniken-Essen-Mitte, Innere Medizin, Essen
Essen, Germany, 45136
Sujan Surgical Cancer Hospital
Amravati, India, 444606
KIDWAI memoraial Institute of oncology
Bangalore, India, 560029
Bibi General Hospital and Cancer Centre
Hyderabad, India, 500 024
Natinal Cancer Institute
Maharagama, India
Mater Misericordiae University Hospital
Dublin 7, Ireland
Sourasky Medical Center
Tel-Aviv, Israel, 64239
Korea, Republic of
National Cancer Center
Goyang, Korea, Republic of, 410-769
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Korea University Anam Hospital
Seoul, Korea, Republic of, 136-705
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Hospital de Jesus
Colonia Centro, Mexico, 06090
Albert SchweitzerZiekenhuis
Dordrecht, Netherlands, 3318 AT
Hospital Nacional Adolfo Guevara Velasco
Cusco, Peru, 84
Bialystock's Oncology Center
Bialystok, Poland, 15-027
Ziemia Lubelska Oncological Center, Lublin
Lublin, Poland, 20-099
Military Medical Institute
Warsaw, Poland, 04 141
Instituto Português de Oncologia de Coimbra Francisco Gentil
Coimbra, Portugal, 3000-075
IPO Porto Francisco Gentil, EPE, Oncology Dep.
Porto, Portugal, 4200-072
Russian Federation
Republic Clinical Oncology Dispensary, Dept. Chemotherapy
Kazan, Russian Federation, 420029
N.A. Semashko Central Clinical Hospital, Moscow
Moscow, Russian Federation, 129128
Regional Clinical Oncology Dispensary
Saint Petersburg, Russian Federation, 191104
National Cancer Centre
Singapore, Singapore, 169610
Johns Hopkins Singapore International Medical Center
Singapore, Singapore, 308433
National Institute of Oncology, Bratislava
Bratislava, Slovakia, 833 10
Institute of Oncology Ljubljana
Ljubljana, Slovenia, 1000
Hospital Universitari Dexeus
Barcelona, Spain, 08028
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Complejo Hospitalario Universitario Insular - Materno Infantil
Las Palmas de Gran Canaria, Spain, 35016
Hospital Clínico San Carlos
Madrid, Spain, 28040
Hospital Clínico de Santiago
Santiago de Compostela, Spain, 15706
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, 807
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 81362
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Tainan, Taiwan, 704
National Taiwan University Hospital
Taipei, Taiwan, 100
Chang Gung Memorial Hospital(TaoYuan)
Taoyuan County, Taiwan, 333
Hacettepe Universitesi Tip Fakultesi, Ic Hastaliklari ABD
Ankara, Turkey
Ege Universitesi Tip Fakultesi Tibbi Onkoloji Bilim Dali
Izmir, Turkey
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01125566     History of Changes
Other Study ID Numbers: 1200.75
2009-015476-98 ( EudraCT Number )
First Submitted: May 10, 2010
First Posted: May 18, 2010
Results First Submitted: June 6, 2014
Results First Posted: August 21, 2014
Last Update Posted: September 25, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action