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.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01125566
First received: May 10, 2010
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]

    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) ] [ Designated as safety issue: No ]

    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. ] [ Designated as safety issue: No ]

    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
Study Start Date: June 2010
Estimated Study Completion Date: May 2018
Primary Completion Date: June 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01125566

  Hide Study Locations
Locations
United States, Alabama
1200.75.10013 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
United States, Arizona
1200.75.10051 Boehringer Ingelheim Investigational Site
Chandler, Arizona, United States
United States, California
1200.75.10113 Boehringer Ingelheim Investigational Site
Alhambra, California, United States
1200.75.10010 Boehringer Ingelheim Investigational Site
Fountain Valley, California, United States
1200.75.10112 Boehringer Ingelheim Investigational Site
Fullerton, California, United States
1200.75.10004 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
1200.75.10109 Boehringer Ingelheim Investigational Site
Redondo Beach, California, United States
1200.75.10103 Boehringer Ingelheim Investigational Site
Santa Barbara, California, United States
1200.75.10102 Boehringer Ingelheim Investigational Site
Santa Maria, California, United States
United States, Illinois
1200.75.10031 Boehringer Ingelheim Investigational Site
Skokie, Illinois, United States
United States, Iowa
1200.75.10020 Boehringer Ingelheim Investigational Site
Waterloo, Iowa, United States
United States, New York
1200.75.10044 Boehringer Ingelheim Investigational Site
Lake Success, New York, United States
United States, North Carolina
1200.75.10110 Boehringer Ingelheim Investigational Site
Asheville, North Carolina, United States
United States, Pennsylvania
1200.75.10048 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
United States, Utah
1200.75.10043 Boehringer Ingelheim Investigational Site
Salt lake City, Utah, United States
Argentina
1200.75.54005 Boehringer Ingelheim Investigational Site
Buenos Aires, Argentina
1200.75.54001 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
1200.75.54010 Boehringer Ingelheim Investigational Site
Ciudad Autonoma de Buenos Aires, Argentina
1200.75.54009 Boehringer Ingelheim Investigational Site
Cordoba, Argentina
1200.75.54008 Boehringer Ingelheim Investigational Site
Pergamino - Buenos Aires, Argentina
1200.75.54003 Boehringer Ingelheim Investigational Site
Quilmes, Argentina
1200.75.54004 Boehringer Ingelheim Investigational Site
Rosario, Argentina
Australia, New South Wales
1200.75.61002 Boehringer Ingelheim Investigational Site
Port Macquarie, New South Wales, Australia
Australia, Victoria
1200.75.61001 Boehringer Ingelheim Investigational Site
Fitzroy, Victoria, Australia
1200.75.61007 Boehringer Ingelheim Investigational Site
Frankston, Victoria, Australia
1200.75.61004 Boehringer Ingelheim Investigational Site
Ringwood East, Victoria, Australia
Australia, Western Australia
1200.75.61006 Boehringer Ingelheim Investigational Site
Perth, Western Australia, Australia
Austria
1200.75.43002 Boehringer Ingelheim Investigational Site
Linz, Austria
1200.75.43001 Boehringer Ingelheim Investigational Site
Wien, Austria
Belarus
1200.75.37504 Boehringer Ingelheim Investigational Site
Grodno, Belarus
1200.75.37502 Boehringer Ingelheim Investigational Site
Minsk, Belarus
1200.75.37501 Boehringer Ingelheim Investigational Site
Minsk region, Belarus
1200.75.37503 Boehringer Ingelheim Investigational Site
Vitebsk, Belarus
Belgium
1200.75.32001 Boehringer Ingelheim Investigational Site
Bruxelles, Belgium
1200.75.32005 Boehringer Ingelheim Investigational Site
Edegem, Belgium
1200.75.32003 Boehringer Ingelheim Investigational Site
Liège, Belgium
Brazil
1200.75.55003 Boehringer Ingelheim Investigational Site
Cachoeiro de Itapemirim, Brazil
1200.75.55010 Boehringer Ingelheim Investigational Site
Curitiba, Brazil
1200.75.55012 Boehringer Ingelheim Investigational Site
Ijui, Brazil
1200.75.55019 Boehringer Ingelheim Investigational Site
Pelotas, Brazil
1200.75.55005 Boehringer Ingelheim Investigational Site
Porto Alegre, Brazil
1200.75.55008 Boehringer Ingelheim Investigational Site
Porto Alegre, Brazil
1200.75.55002 Boehringer Ingelheim Investigational Site
Porto Alegre, Brazil
1200.75.55004 Boehringer Ingelheim Investigational Site
Rio de Janeiro, Brazil
1200.75.55011 Boehringer Ingelheim Investigational Site
Santo André, Brazil
1200.75.55016 Boehringer Ingelheim Investigational Site
Sao Paulo, Brazil
1200.75.55020 Boehringer Ingelheim Investigational Site
Sao Paulo, Brazil
Canada, British Columbia
1200.75.11005 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
Canada, New Brunswick
1200.75.11002 Boehringer Ingelheim Investigational Site
Moncton, New Brunswick, Canada
Canada, Ontario
1200.75.11004 Boehringer Ingelheim Investigational Site
Kitchener, Ontario, Canada
1200.75.11006 Boehringer Ingelheim Investigational Site
Ottawa, Ontario, Canada
1200.75.11003 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
Canada, Quebec
1200.75.11001 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
Canada
1200.75.11007 Boehringer Ingelheim Investigational Site
Quebec, Canada
Chile
1200.75.56001 Boehringer Ingelheim Investigational Site
Temuco, Chile
China
1200.75.86001 Boehringer Ingelheim Investigational Site
Beijing, China
1200.75.86005 Boehringer Ingelheim Investigational Site
Beijing, China
1200.75.86003 Boehringer Ingelheim Investigational Site
Beijing, China
1200.75.86002 Boehringer Ingelheim Investigational Site
Beijing, China
1200.75.86004 Boehringer Ingelheim Investigational Site
Beijing, China
1200.75.86008 Boehringer Ingelheim Investigational Site
Changchun, China
1200.75.86021 Boehringer Ingelheim Investigational Site
Chengdu, China
1200.75.86019 Boehringer Ingelheim Investigational Site
Fuzhou, China
1200.75.86016 Boehringer Ingelheim Investigational Site
Guangzhou, China
1200.75.86018 Boehringer Ingelheim Investigational Site
Guangzhou, China
1200.75.86017 Boehringer Ingelheim Investigational Site
Guangzhou, China
1200.75.86022 Boehringer Ingelheim Investigational Site
Haerbin, China
1200.75.86013 Boehringer Ingelheim Investigational Site
Hangzhou, China
1200.75.86012 Boehringer Ingelheim Investigational Site
Hangzhou, China
1200.75.86015 Boehringer Ingelheim Investigational Site
Jinan, China
1200.75.86011 Boehringer Ingelheim Investigational Site
Nanjing, China
1200.75.86010 Boehringer Ingelheim Investigational Site
Shanghai, China
1200.75.86009 Boehringer Ingelheim Investigational Site
Shanghai, China
1200.75.86006 Boehringer Ingelheim Investigational Site
Tianjin, China
1200.75.86020 Boehringer Ingelheim Investigational Site
Wuhan, China
Czech Republic
1200.75.42004 Boehringer Ingelheim Investigational Site
Ceske Budejovice, Czech Republic
1200.75.42003 Boehringer Ingelheim Investigational Site
Olomouc, Czech Republic
1200.75.42001 Boehringer Ingelheim Investigational Site
Prague 2, Czech Republic
1200.75.42002 Boehringer Ingelheim Investigational Site
Praha 4, Czech Republic
Egypt
1200.75.20003 Boehringer Ingelheim Investigational Site
Cairo, Egypt
1200.75.20001 Boehringer Ingelheim Investigational Site
Mansoura, Egypt
France
1200.75.33020 Boehringer Ingelheim Investigational Site
Amiens Cedex 1, France
1200.75.33011 Boehringer Ingelheim Investigational Site
Angers Cedex 9, France
1200.75.33007 Boehringer Ingelheim Investigational Site
Besançon Cedex, France
1200.75.33009 Boehringer Ingelheim Investigational Site
Bordeaux, France
1200.75.33006 Boehringer Ingelheim Investigational Site
Clermont-Ferrand Cedex, France
1200.75.33014 Boehringer Ingelheim Investigational Site
Le Mans, France
1200.75.33013 Boehringer Ingelheim Investigational Site
Nantes, France
1200.75.33012 Boehringer Ingelheim Investigational Site
Paris, France
1200.75.33001 Boehringer Ingelheim Investigational Site
Reims, France
1200.75.33016 Boehringer Ingelheim Investigational Site
Rennes Cedex, France
1200.75.33021 Boehringer Ingelheim Investigational Site
St Cloud, France
1200.75.33008 Boehringer Ingelheim Investigational Site
Strasbourg Cedex, France
Germany
1200.75.49004 Boehringer Ingelheim Investigational Site
Aachen, Germany
1200.75.49013 Boehringer Ingelheim Investigational Site
Bonn, Germany
1200.75.49026 Boehringer Ingelheim Investigational Site
Bottrop, Germany
1200.75.49002 Boehringer Ingelheim Investigational Site
Deggendorf, Germany
1200.75.49009 Boehringer Ingelheim Investigational Site
Erlangen, Germany
1200.75.49021 Boehringer Ingelheim Investigational Site
Essen, Germany
1200.75.49008 Boehringer Ingelheim Investigational Site
Hildesheim, Germany
1200.75.49001 Boehringer Ingelheim Investigational Site
Köln, Germany
1200.75.49006 Boehringer Ingelheim Investigational Site
Köln, Germany
1200.75.49014 Boehringer Ingelheim Investigational Site
Magdeburg, Germany
1200.75.49025 Boehringer Ingelheim Investigational Site
München, Germany
1200.75.49007 Boehringer Ingelheim Investigational Site
München, Germany
1200.75.49011 Boehringer Ingelheim Investigational Site
Oldenburg, Germany
1200.75.49012 Boehringer Ingelheim Investigational Site
Rostock, Germany
1200.75.49024 Boehringer Ingelheim Investigational Site
Wuppertal, Germany
India
1200.75.91010 Boehringer Ingelheim Investigational Site
Amravati, India
1200.75.91001 Boehringer Ingelheim Investigational Site
Bangalore, India
1200.75.91017 Boehringer Ingelheim Investigational Site
Chennai, India
1200.75.91011 Boehringer Ingelheim Investigational Site
Hyderabad, India
1200.75.91009 Boehringer Ingelheim Investigational Site
Kolkata, India
1200.75.91013 Boehringer Ingelheim Investigational Site
Nagpur, India
1200.75.91006 Boehringer Ingelheim Investigational Site
Nashik, India
1200.75.91022 Boehringer Ingelheim Investigational Site
Pune, India
1200.75.91004 Boehringer Ingelheim Investigational Site
Pune, India
1200.75.91005 Boehringer Ingelheim Investigational Site
Visakhapatnam, India
Ireland
1200.75.35307 Boehringer Ingelheim Investigational Site
Dubliin 9, Ireland
1200.75.35301 Boehringer Ingelheim Investigational Site
Dublin 4, Ireland
1200.75.35306 Boehringer Ingelheim Investigational Site
Dublin 7, Ireland
1200.75.35303 Boehringer Ingelheim Investigational Site
Dublin 7, Ireland
1200.75.35302 Boehringer Ingelheim Investigational Site
Dublin 8, Ireland
1200.75.35305 Boehringer Ingelheim Investigational Site
Galway, Ireland
1200.75.35304 Boehringer Ingelheim Investigational Site
Limerick, Ireland
Israel
1200.75.97203 Boehringer Ingelheim Investigational Site
Haifa, Israel
1200.75.97205 Boehringer Ingelheim Investigational Site
Jerusalem, Israel
1200.75.97210 Boehringer Ingelheim Investigational Site
Kfar Saba, Israel
1200.75.97201 Boehringer Ingelheim Investigational Site
Tel Hashomer, Israel
1200.75.97206 Boehringer Ingelheim Investigational Site
Tel-Aviv, Israel
Italy
1200.75.39008 Boehringer Ingelheim Investigational Site
Ferrara, Italy
1200.75.39001 Boehringer Ingelheim Investigational Site
Milan, Italy
1200.75.39007 Boehringer Ingelheim Investigational Site
Monserrato (CA), Italy
Japan
1200.75.81005 Boehringer Ingelheim Investigational Site
Chuo-ku, Tokyo, Japan
1200.75.81013 Boehringer Ingelheim Investigational Site
Higashinari-ku, Osaka, Japan
1200.75.81008 Boehringer Ingelheim Investigational Site
Isehara-shi, Kanagawa, Japan
Korea, Republic of
1200.75.82001 Boehringer Ingelheim Investigational Site
Goyang, Korea, Republic of
1200.75.82002 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1200.75.82003 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1200.75.82005 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1200.75.82004 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1200.75.82006 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
Latvia
1200.75.37102 Boehringer Ingelheim Investigational Site
Riga, Latvia
1200.75.37101 Boehringer Ingelheim Investigational Site
Riga, Latvia
Lebanon
1200.75.96101 Boehringer Ingelheim Investigational Site
Lebanon, Lebanon
Lithuania
1200.75.37001 Boehringer Ingelheim Investigational Site
Kaunas, Lithuania
1200.75.37002 Boehringer Ingelheim Investigational Site
Vilnius, Lithuania
Mexico
1200.75.52003 Boehringer Ingelheim Investigational Site
Colonia Centro, Mexico
1200.75.52006 Boehringer Ingelheim Investigational Site
San Luis Potosi, Mexico
Netherlands
1200.75.31003 Boehringer Ingelheim Investigational Site
Dordrecht, Netherlands
1200.75.31004 Boehringer Ingelheim Investigational Site
Eindhoven, Netherlands
1200.75.31001 Boehringer Ingelheim Investigational Site
Geleen, Netherlands
1200.75.31006 Boehringer Ingelheim Investigational Site
Heerlen, Netherlands
1200.75.31005 Boehringer Ingelheim Investigational Site
Maastricht, Netherlands
1200.75.31009 Boehringer Ingelheim Investigational Site
Zwolle, Netherlands
Peru
1200.75.51007 Boehringer Ingelheim Investigational Site
Arequipa, Peru
1200.75.51004 Boehringer Ingelheim Investigational Site
Cusco, Peru
1200.75.51005 Boehringer Ingelheim Investigational Site
Lima, Peru
1200.75.51002 Boehringer Ingelheim Investigational Site
Miraflores, Peru
1200.75.51001 Boehringer Ingelheim Investigational Site
San Isidro, Peru
1200.75.51006 Boehringer Ingelheim Investigational Site
Trujillo, Peru
Poland
1200.75.48002 Boehringer Ingelheim Investigational Site
Bialystok, Poland
1200.75.48006 Boehringer Ingelheim Investigational Site
Bytom, Poland
1200.75.48003 Boehringer Ingelheim Investigational Site
Gdansk, Poland
1200.75.48004 Boehringer Ingelheim Investigational Site
Lodz, Poland
1200.75.48007 Boehringer Ingelheim Investigational Site
Lublin, Poland
1200.75.48001 Boehringer Ingelheim Investigational Site
Olsztyn, Poland
1200.75.48013 Boehringer Ingelheim Investigational Site
Poznan, Poland
1200.75.48010 Boehringer Ingelheim Investigational Site
Warsaw, Poland
Portugal
1200.75.35104 Boehringer Ingelheim Investigational Site
Coimbra, Portugal
1200.75.35102 Boehringer Ingelheim Investigational Site
Coimbra, Portugal
1200.75.35101 Boehringer Ingelheim Investigational Site
Lisboa, Portugal
1200.75.35110 Boehringer Ingelheim Investigational Site
Porto, Portugal
1200.75.35103 Boehringer Ingelheim Investigational Site
Porto, Portugal
Russian Federation
1200.75.07006 Boehringer Ingelheim Investigational Site
Kazan, Russian Federation
1200.75.07008 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
1200.75.07011 Boehringer Ingelheim Investigational Site
Ryazan, Russian Federation
1200.75.07001 Boehringer Ingelheim Investigational Site
Saint Petersburg, Russian Federation
Singapore
1200.75.65001 Boehringer Ingelheim Investigational Site
Singapore, Singapore
1200.75.65003 Boehringer Ingelheim Investigational Site
Singapore, Singapore
1200.75.65002 Boehringer Ingelheim Investigational Site
Singapore, Singapore
Slovakia
1200.75.42103 Boehringer Ingelheim Investigational Site
Bardejov, Slovakia
1200.75.42102 Boehringer Ingelheim Investigational Site
Bratislava, Slovakia
1200.75.42104 Boehringer Ingelheim Investigational Site
Poprad, Slovakia
Slovenia
1200.75.38601 Boehringer Ingelheim Investigational Site
Ljubljana, Slovenia
South Africa
1200.75.27001 Boehringer Ingelheim Investigational Site
Johannesburg, South Africa
1200.75.27006 Boehringer Ingelheim Investigational Site
Johannesburg, South Africa
1200.75.27004 Boehringer Ingelheim Investigational Site
Kraaifontein, South Africa
1200.75.27005 Boehringer Ingelheim Investigational Site
Port Elizabeth, South Africa
1200.75.27008 Boehringer Ingelheim Investigational Site
Rondebosch, Cape Town, South Africa
Spain
1200.75.34001 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1200.75.34011 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1200.75.34002 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1200.75.34004 Boehringer Ingelheim Investigational Site
Las Palmas de Gran Canaria, Spain
1200.75.34007 Boehringer Ingelheim Investigational Site
Madrid, Spain
1200.75.34009 Boehringer Ingelheim Investigational Site
Santiago de Compostela, Spain
1200.75.34005 Boehringer Ingelheim Investigational Site
Toledo, Spain
1200.75.34008 Boehringer Ingelheim Investigational Site
Valencia, Spain
Sri Lanka
1200.75.94001 Boehringer Ingelheim Investigational Site
Maharagama, Sri Lanka
Taiwan
1200.75.88607 Boehringer Ingelheim Investigational Site
Changhua, Taiwan
1200.75.88604 Boehringer Ingelheim Investigational Site
Kaohsiung, Taiwan
1200.75.88608 Boehringer Ingelheim Investigational Site
Kaohsiung, Taiwan
1200.75.88602 Boehringer Ingelheim Investigational Site
Taichung, Taiwan
1200.75.88609 Boehringer Ingelheim Investigational Site
Tainan, Taiwan
1200.75.88610 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
1200.75.88606 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
1200.75.88601 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
1200.75.88603 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
1200.75.88605 Boehringer Ingelheim Investigational Site
Taoyuan County, Taiwan
Turkey
1200.75.90002 Boehringer Ingelheim Investigational Site
Ankara, Turkey
1200.75.90001 Boehringer Ingelheim Investigational Site
Izmir, Turkey
United Kingdom
1200.75.44002 Boehringer Ingelheim Investigational Site
Dundee, United Kingdom
1200.75.44003 Boehringer Ingelheim Investigational Site
Edinburgh, United Kingdom
1200.75.44001 Boehringer Ingelheim Investigational Site
London, United Kingdom
1200.75.44007 Boehringer Ingelheim Investigational Site
London, United Kingdom
1200.75.44006 Boehringer Ingelheim Investigational Site
Sutton, United Kingdom
1200.75.44005 Boehringer Ingelheim Investigational Site
Woolwich, London, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01125566     History of Changes
Other Study ID Numbers: 1200.75, 2009-015476-98
Study First Received: May 10, 2010
Results First Received: June 6, 2014
Last Updated: August 5, 2014
Health Authority: Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica
Australia: Dept of Health and Ageing Therapeutic Goods Admin
Austria: Medicines and Medical Devices Agency
Belarus: Ministry of Health
Belgium: Federal Agency for Medicinal and Health Products
Brazil: National Health Surveillance Agency
Canada: Health Canada
Chile: Comision Nacional De Investigacion Cientifica y Tecnologica
China: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Egypt: Ministry of Health and Population
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
India: Drugs Controller General of India
Ireland: Irish Medicines Board
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: Ethics Committee
Japan: Ministry of Health, Labor and Welfare
Latvia: State Agency of Medicines
Lebanon: Ministry of Public Health
Lithuania: State Medicine Control Agency - Ministry of Health
Mexico: Federal Commission for Protection Against Health Risks
Netherlands: Central Committee Research Involving Human Subjects
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Poland: Registration Medicinal Product Medical Device Biocidal Product
Portugal: National Pharmacy and Medicines Institute
Russia: Pharmacological Committee, Ministry of Health
Singapore: Health Sciences Authority
Slovakia: State Institute for Drug Control
Slovenia: Agency for Medicinal Products - Ministry of Health
South Africa: Medicines Control Council
South Korea: Ministry of Food and Drug Safety (MFDS)
Spain: Ministry of Health
Sri Lanka: Ministry of Healthcare and Nutrition
Taiwan : Food and Drug Administration
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Trastuzumab
Vinblastine
Vinorelbine
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 29, 2014