AzTrials
AzTrials

Breast NeoplasmsPhase 3NCT01125566

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

A Phase 3 study testing BIBW 2992, trastuzumab and vinorelbine in people with Breast Neoplasms, run by Boehringer Ingelheim at 207 sites in 38 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Neoplasms
What is being tested?
BIBW 2992, trastuzumab and vinorelbine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
508 participants
Where
207 sitesin 38 countries
Study dates
22 Jun 2010to 6 Jul 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 .

Who cannot join

  • 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%.
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  • 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

Trial locations and contacts

207 sites in 38 countries.

207 sites in 38 countries

China20 sites

  • Cancer Hospital of Chinese Academy of Medical Science

    Beijing, 100021

  • Peking Union Medical College Hospital

    Beijing, 100032

  • Peking University People's Hospital

    Beijing, 100044

  • 307 Hospital of PLA

    Beijing, 100071

  • Chinese PLA General Hospital

    Beijing, 100853

  • First Hospital of Jilin University

    Changchun, 130021

  • West China Hospital

    Chengdu, 610041

  • Fujian Provincial Tumor Hospital

    Fuzhou, 350014

  • Sun Yat-Sen University Cancer Center

    Guangzhou, 510060

  • Guangdong Provincial People's Hospital

    Guangzhou, 510080

  • NanFang Hosptial

    Guangzhou, 510515

  • The Third Affiliated Hospital of Harbin Medical University

    Haerbin, 150081

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, 310009

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

  • Qilu Hospital, Shangdong University

    Jinan, 250012

  • the 81th Hospital of PLA

    Nanjing, 210002

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, 200025

  • Fudan University Shanghai Cancer Center

    Shanghai, 200033

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, 300060

  • Wuhan Union Hospital

    Wuhan, 430022

Other trials in China

Germany15 sites

  • Universitätsklinikum Aachen, AöR

    Aachen, 52074

  • Medizinisches Zentrum Bonn

    Bonn, 53111

  • OnkoDok GbR

    Bottrop, 46236

  • Universitätsklinikum Köln (AöR)

    Cologne, 50931

  • St. Elisabeth-Krankenhaus

    Cologne, 50935

  • DONAUISAR Klinikum Deggendorf-Dingolfing-Landau gKU

    Deggendorf, 94469

  • Universitätsklinikum Erlangen

    Erlangen, 91054

  • Kliniken Essen - Mitte gGmbH

    Essen, 45136

  • Gynäk.-onkol. Gem.praxis, Dr. Uleer, Hildesheim

    Hildesheim, 31134

  • Universitätsklinikum Magdeburg AöR

    Magdeburg, 39108

  • Klinikum der Universität München - Campus Innenstadt

    München, 80337

  • Klinikum rechts der Isar der Technischen Universität München

    München, 81675

  • Onkologische Praxis Oldenburg

    Oldenburg, 26121

  • Universitätsfrauenklinik am Klinikum Südstadt

    Rostock, 18059

  • Facharzt für Innere Medizin

    Wuppertal, 42105

Other trials in Germany

United States14 sites

  • Hope Women's Cancer Center

    Asheville, North Carolina, 28806

  • Achieve Clinical Research, LLC

    Birmingham, Alabama, 35216

  • Ironwood Cancer and Research Centers

    Chandler, Arizona, 85224

  • Robert A. Moss MD, FACP, Inc

    Fountain Valley, California, 92708

  • St. Jude Heritage Healthcare

    Fullerton, California, 92835

  • Pro Health Care Associated

    Lake Success, New York, 11042

  • University of California

    Los Angeles, California, 90095

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Cancer Care Associates Medical Group, Inc

    Redondo Beach, California, 90277

  • Utah Cancer Specialists Cancer Center

    Salt Lake City, Utah, 84106

  • Santa Barbara Hematology Oncology Medical Group, Inc

    Santa Barbara, California, 93105

  • Central Coast Medical Oncology Corporation

    Santa Maria, California, 93454

  • North Shore Cancer Research Associates

    Skokie, Illinois, 60076

  • Cedar Valley Cancer Center

    Waterloo, Iowa, 50701

Other trials in United States

India13 sites

  • Gujarat Cancer and Research Institute

    Ahmedabad, 380016

  • Sujan Surgical Cancer Hospital

    Amravati, 444606

  • KIDWAI memoraial Institute of oncology

    Bangalore, 560029

  • Sri Venkateshwara Hospital

    Bengaluru, 560068

  • Dr. Rai Memorial Cancer Centre

    Chennai, 600018

  • Bibi General Hospital and Cancer Centre

    Hyderabad, 500 024

  • Orchid Nursing Home

    Kolkata, 700054

  • Natinal Cancer Institute

    Maharagama

  • Central India Cancer Research Institute

    Nagpur, 440 010

  • Curie Manavata Cancer centre

    Nashik, 422004

  • Jehangir Hospital Oncology Department

    Pune, 411001

  • K.E.M Hospital

    Pune, 411011

  • King George Hospital

    Visakhapatnam, 530002

Other trials in India

France12 sites

  • HOP Amiens-Picardie Sud

    Amiens, 80054

  • CTR P Papin, Onco, Angers

    Angers, 49933

  • HOP Jean Minjoz

    Besançon, 25030

  • CLI Bordeaux Nord Aquitaine

    Bordeaux, 33300

  • CTR J Perrin, Onco, Clermont-Ferrand

    Clermont-Ferrand, 63011

  • HOP Victor Hugo

    Le Mans, 72000

  • CTR Catherine de Sienne

    Nantes, 44202

  • HOP Saint-Louis

    Paris, 75475

  • INS Jean Godinot, Onco, Reims

    Reims, 51000

  • CTR Eugène Marquis

    Rennes, 35042

  • CTR René Huguenin

    Saint-Cloud, 92210

  • CTR Paul Strauss

    Strasbourg, 67065

Other trials in France

Taiwan10 sites

  • Chang-Hua Christian Hospital

    Changhua, 50006

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81362

  • Taichung Veterans General Hospital

    Taichung, 40705

  • NCKUH

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 100

  • Mackay Memorial Hospital

    Taipei, 10449

  • Taipe Veterans General Hospital

    Taipei, 11217

  • Koo Foundation Sun Yet-Sen Cancer Center

    Taipei, 112

  • Chang Gung Memorial Hospital(TaoYuan)

    Taoyuan County, 333

Other trials in Taiwan

Brazil9 sites

  • Centro de Pesquisas Clínicas em Oncología

    Cachoeiro de Itapemirim, 29308-014

  • Hospital Santa Cruz

    Curitiba, 80420-090

  • Associacao Hospital de Caridade de Ijui

    Ijuí, 98700-000

  • Associação Hospitalar Moinhos de Vento

    Porto Alegre, 90035-001

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, 90050-170

  • Centro de Novos Tratamentos CliniOnco

    Porto Alegre, 90430-090

  • Instituto Nacional do Câncer - INCA

    Rio de Janeiro, 20560-120

  • Faculdade de Medicina do ABC

    Santo André, 09060-650

  • Centro de Referência da Saude da Mulher-Hosp Perola Byington

    São Paulo, 01317-000

Other trials in Brazil

Poland8 sites

  • Bialystock's Oncology Center

    Bialystok, 15-027

  • Wojewodzki Specialist Hospital No. 4, Bytom

    Bytom, 41-902

  • University Clinical Center, Gdansk

    Gdansk, 80-211

  • Provincial Specialist M. Kopernik Hospital

    Lodz, 93-513

  • Ziemia Lubelska Oncological Center, Lublin

    Lublin, 20-099

  • Oncology Centre of Olsztyn "KOPERNIK" Sp. z.o.o.

    Olsztyn, 10-513

  • Wielkopolskie Oncology Centre n.a. Maria Sklodowska-Courie

    Poznan, 61-866

  • Military Medical Institute

    Warsaw, 04 141

Other trials in Poland

Spain8 sites

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Universitari Dexeus

    Barcelona, 08028

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Complejo Hospitalario Universitario Insular - Materno Infantil

    Las Palmas de Gran Canaria, 35016

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Hospital Clínico de Santiago

    Santiago de Compostela, 15706

  • Hospital Virgen de la Salud

    Toledo, 45004

  • Hospital Arnau de Vilanova

    Valencia, 46015

Other trials in Spain

Canada7 sites

  • Grand River Regional Cancer Centre

    Kitchener, Ontario, N2G 1G3

  • Dr. Leon Richard Oncology Centre

    Moncton, New Brunswick, E1C 8X3

  • Hopital Notre-Dame du CHUM

    Montreal, Quebec, H2L 4M1

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

  • CHU de Quebec-Universite Laval Research Centre

    Québec, G1S 4L8

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

  • BC Cancer Agency - Vancouver

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Netherlands6 sites

  • Albert SchweitzerZiekenhuis

    Dordrecht, 3318 AT

  • Máxima Medisch Centrum, locatie Eindhoven

    Eindhoven, 3651 BM

  • Zuyderland Medisch Centrum

    Geleen, 6162 BG

  • Zuyderland Medisch Centrum

    Heerlen, 6419 PC

  • METC Academisch Ziekenhuis Maastricht/Universiteit van Maastricht

    Maastricht, 6229 HX

  • Isala Zwolle

    Zwolle, 8025 BP

Other trials in Netherlands

South Africa6 sites

  • WCR CMJAH Clinical Trial Site

    Johannesburg, 2193

  • Medical Oncology Centre of Rosebank

    Johannesburg, 2196

  • GVI oncology Medi Clinic

    Kraaifontein, 7570

  • Langenhoven Drive Oncology Centre

    Port Elizabeth, 6045

  • Wilgers oncology

    Pretoria, 0041

  • Rondebosch Oncology Centre

    Rondebosch, Cape Town, 7700

Other trials in South Africa

South Korea6 sites

  • National Cancer Center

    Goyang, 410-769

  • Korea University Anam Hospital

    Seoul, 02841

  • Seoul National University Hospital

    Seoul, 110-744

  • Severance Hospital

    Seoul, 120-752

  • Samsung Medical Center

    Seoul, 135-710

  • Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

Australia5 sites

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Peninsula Haematology & Oncology

    Frankston, Victoria, 3199

  • Mount Medical Centre

    Perth, Western Australia, 6000

  • Port Macquarie Base Hospital (PMBH)

    Port Macquarie, New South Wales, 2444

  • Maroondah Hospital

    Ringwood East, Victoria, 3135

Other trials in Australia

Israel5 sites

  • Rambam Medical Center

    Haifa, 31096

  • Shaare Zedek Medical Center, Jerusalem 91031

    Jerusalem, 91031

  • Meir Medical Center

    Kfar Saba, 44281

  • Sourasky Medical Center

    Tel Aviv, 64239

  • The Chaim Sheba Medical Center Tel Hashomer

    Tel HaShomer, 52621

Other trials in Israel

Portugal5 sites

  • Instituto Português de Oncologia de Coimbra Francisco Gentil

    Coimbra, 3000-075

  • CHUC, EPE - CHC-Maternidade Bissaya Barreto

    Coimbra, 3041-801

  • IPO Lisboa Francisco Gentil, EPE

    Lisbon, 1099-023

  • Centro Hospitalar São João,EPE

    Porto, 420-451

  • IPO Porto Francisco Gentil, EPE

    Porto, 4200-072

Other trials in Portugal

Argentina4 sites

  • Instituto Medico de Asistencia e Investigaciones S. A.

    Buenos Aires, C1425AWC

  • Hospital Britanico

    Capital Federal, C1280AEB

  • Sanatorio de la Provodencia

    Ciudad Autonoma de Bs As, C1050AAK

  • Sanatorio Parque

    Rosario, S2000DSK

Other trials in Argentina

Belarus4 sites

  • Grodno Regional Clinical Hospital

    Grodno, 230017

  • Public Health Inst. Minsk City Clinical Oncology Dispensary

    Minsk, 220013

  • N. N. Alexandrov National Cancer Center of Belarus

    Minsk Region, 223040

  • Vitebsk Regional Clinical Oncology Dispensary

    Vitebsk, 210603

Other trials in Belarus

Czechia4 sites

  • Hospital Ceske Budejovice

    České Budějovice, 370 87

  • University Hospital Olomouc

    Olomouc, 775 20

  • General Faculty Hospital, Prague

    Prague, 128 08

  • MEDICON a.s., Praha 4

    Prague, 140 44

Other trials in Czechia

Ireland4 sites

  • Beaumont Hospital

    Dubliin 9

  • Mater Misericordiae University Hospital

    Dublin

  • St James's Hospital

    Dublin

  • St Vincent's University Hospital

    Dublin

Other trials in Ireland

Peru4 sites

  • Hospital Nacional Adolfo Guevara Velasco

    Cusco, 84

  • Clinica San Judas Tadeo

    Lima

  • Instituto Oncologico Miraflores S.A.

    Miraflores

  • Clinica Peruano Americana de Trujillo

    Trujillo

Other trials in Peru

Russia4 sites

  • St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan"

    Kazan', 420029

  • N.A. Semashko Central Clinical Hospital, Moscow

    Moscow, 129128

  • GUZ "Regional Clinical Oncology Dispensary"

    Ryazan, 390011

  • Regional Clinical Oncology Dispensary

    Saint Petersburg, 191104

Other trials in Russia

United Kingdom4 sites

  • Ninewells Hospital & Medical School

    Dundee, DD1 9SY

  • Guy's Hospital

    London, SE1 9RT

  • The Royal Marsden Hospital

    Sutton, SM2 5PT

  • Queen Elizabeth Hospital

    Woolwich, London, SE18 4QH

Other trials in United Kingdom

Belgium3 sites

  • Brussels - HOSP Jules Bordet

    Brussels, 1000

  • Edegem - UNIV UZ Antwerpen

    Edegem, 2650

  • Liège - HOSP St-Joseph

    Liège, 4000

Other trials in Belgium

Italy3 sites

  • Azienda Ospedaliera Universitaria Arcispedale Sant'Anna

    Ferrara, 44124

  • Istituto Europeo di Oncologia

    Milan, 20141

  • P.O. Monserrato

    Monserrato (CA), 09042

Other trials in Italy

Japan3 sites

  • Tokai University Hospital

    Kanagawa, Isehara, 259-1193

  • Osaka Medical Center for Cancer and Cardiovascular Diseases

    Osaka, Osaka, 537-8511

  • National Cancer Center Hospital

    Tokyo, Chuo-ku, 104-0045

Other trials in Japan

Singapore3 sites

  • National University Hospital

    Singapore, 119228

  • National Cancer Centre

    Singapore, 169610

  • Johns Hopkins Singapore International Medical Center

    Singapore, 308433

Other trials in Singapore

Slovakia3 sites

  • St. Jacobs Hosp.Outpat.Pneumology&Phthisiology Dept,Bardejov

    Bardejov, 085 01

  • National Institute of Oncology, Bratislava

    Bratislava, 833 10

  • POKO Policlinic Dept. of Clinical Oncology

    Poprad, 058 01

Other trials in Slovakia

Austria2 sites

  • Ordensklinikum Linz GmbH - Barmherzige Schwestern

    Linz, 4020

  • Kaiser Franz Josef Spital Vienna

    Vienna, 1100

Other trials in Austria

Egypt2 sites

  • Oncology Centre- Mansoura University

    Al Mansurah, 35516

  • El Manial Specialized Hospital

    Cairo, 11553

Other trials in Egypt

Latvia2 sites

  • P. Stradins Clinical Univ. Hospital, Oncology Clinic

    Riga, 1002

  • Riga East Univ. Hospital, Oncology Centre

    Riga, 1079

Other trials in Latvia

Lithuania2 sites

  • Hospital of Lithuanian Univ.of HealthSciences Kauno Klinikos

    Kaunas, 50009

  • National Cancer Institute, Vilnius

    Vilnius, 08660

Other trials in Lithuania

Turkey (Türkiye)2 sites

  • Hacettepe Universitesi Tip Fakultesi, Ic Hastaliklari ABD

    Ankara

  • Ege Universitesi Tip Fakultesi Tibbi Onkoloji Bilim Dali

    Izmir

Other trials in Turkey (Türkiye)

Chile1 site

  • Instituto Clínico Oncológico del Sur - ICOS

    Temuco

Other trials in Chile

Lebanon1 site

  • Hammoud Hospital University Medical Centre (HHUMC)

    Lebanon

Other trials in Lebanon

Mexico1 site

  • Hospital de Jesus

    Colonia Centro, 06090

Other trials in Mexico

Slovenia1 site

  • Institute of Oncology Ljubljana

    Ljubljana, 1000

Other trials in Slovenia

Sri Lanka1 site

  • Shatabdi Superspeciality Hospital

    Maharashtra, 422002

Other trials in Sri Lanka

About this study

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

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

Being tested
BIBW 2992, trastuzumab, vinorelbine
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BIBW 2992Drug

    patients receive BIBW 2992 tablets once daily and can reduce dose for adverse event management

  • trastuzumabDrug

    patients receive trastuzumab 2mg/kg intravenously every week

  • vinorelbineDrug

    patients receive vinorelbine 25mg/m² intravenously every week

  • vinorelbineDrug

    patients receive vinorelbine 25mg/m² intravenously every week

Study groups in NCT01125566
Study groupRoleWhat they receive
Arm B: trastuzumab with vinorelbineActive comparatorpatients receive weekly intravenous infusion of trastuzumab and vinorelbine
Receives: Drug: trastuzumab; Drug: vinorelbine
Arm A: BIBW 2992 with vinorelbineExperimentalpatients receive BIBW 2992 tablets once daily combined with weekly intravenous infusion of vinorelbine
Receives: Drug: BIBW 2992; Drug: vinorelbine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS)

    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). RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment.

    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

    Measured: From randomization (07Sep2010) until disease progression, death or data cut-off (08Jun2013); Up to 34 months

Secondary outcomes (3)

  1. Overall Survival (OS)

    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.

    Measured: From randomisation (07Sep2010) to database lock (30Jul2018), up to 95 months.

  2. Best RECIST Assessment

    Best RECIST assessment is defined as CR, PR, stable disease (SD), progressive disease (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.

    Measured: From randomization (07Sep2010) until disease progression, death or data cut-off (08Jun2013); Up to 34 months

  3. Objective Response (OR)

    OR is defined as complete response (CR) and partial response (PR). Assessed by investigator according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1. 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

    Measured: Post baseline tumour-imaging was performed at Week 8, 16, 24, 32, 40, 48, 56 and then every 12 weeks (Until final data-base lock on 30 Jul 2018; Up to 95 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2010 (estimated)
  2. Study start22 Jun 2010
  3. Primary completion8 Jun 2013
  4. Study completion6 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
508 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01125566
Sponsor's protocol ID
1200.75
Other IDs
2009-015476-98, 2009
Status last verified
Jul 2019
First submitted
10 May 2010
Last updated
18 Jul 2019

Publications

  • Harbeck N, Huang CS, Hurvitz S, Yeh DC, Shao Z, Im SA, Jung KH, Shen K, Ro J, Jassem J, Zhang Q, Im YH, Wojtukiewicz M, Sun Q, Chen SC, Goeldner RG, Uttenreuther-Fischer M, Xu B, Piccart-Gebhart M; LUX-Breast 1 study group. Afatinib plus vinorelbine versus trastuzumab plus vinorelbine in patients with HER2-overexpressing metastatic breast cancer who had progressed on one previous trastuzumab treatment (LUX-Breast 1): an open-label, randomised, phase 3 trial. Lancet Oncol. 2016 Mar;17(3):357-366. doi: 10.1016/S1470-2045(15)00540-9. Epub 2016 Jan 26.

    PubMed 26822398

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BIBW 2992, trastuzumab and vinorelbine in people with Breast Neoplasms, run by Boehringer Ingelheim at 207 sites in 38 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 207 sites in China, Germany, United States, India, France and 33 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01125566, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019.

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