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A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer (HER2CLIMB)

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.
ClinicalTrials.gov Identifier: NCT02614794
Recruitment Status : Active, not recruiting
First Posted : November 25, 2015
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Brief Summary:

This study is being done to see if tucatinib works better than placebo to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. All patients in the study will get capecitabine and trastuzumab, two drugs that are often used to treat this cancer.

Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo.

Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. They will swallow capecitabine pills two times a day during the first two weeks of each cycle. Patients will get trastuzumab injections from the study site staff on the first day of every cycle.


Condition or disease Intervention/treatment Phase
HER2 Positive Breast Cancer Drug: tucatinib Drug: capecitabine Drug: trastuzumab Drug: placebo Phase 2

Detailed Description:

This is a randomized, international, multi-center, double-blinded study in patients with progressive unresectable locally advanced or metastatic HER2+ breast cancer who have had prior treatment with trastuzumab, pertuzumab and T-DM1. Patients will be randomized in a 2:1 ratio to receive tucatinib or placebo in combination with capecitabine and trastuzumab.

Stratification factors include presence or history of treated or untreated brain metastases or brain lesions of equivocal significance (yes/no), Eastern Cooperative Oncology Group (ECOG) Performance Status (0 vs. 1), and region of world (US vs. Canada vs. Rest of World).

No crossover from placebo to tucatinib will be allowed.

Safety assessments will be performed at a minimum of once every three weeks throughout study treatment and 30 days after the last dose of study drugs. Laboratory assessments will be performed locally at sites. Left ventricular ejection fraction will be assessed by MUGA or ECHO at screening and once every 12 weeks thereafter.

Contrast brain MRI will be performed at baseline in all patients. Efficacy assessments (CT of chest, abdomen and pelvis at a minimum) utilize RECIST 1.1 and include patients with evaluable tumors defined as measurable target lesions and non-measurable non-target lesions. RECIST assessment is performed at baseline, every 6 weeks for the first 24 weeks, and then every 9 weeks thereafter. Repeat MRI of the brain will be required on this same schedule only in those patients with brain metastases identified at baseline. All treatment decisions are made based upon investigator assessment. All patients undergo a repeat MRI of the brain within 30 days of the end of treatment unless previously performed at time of disease progression. Patients in both arms of the study will be followed for OS after completion of study treatment.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 612 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2 Randomized, Double-Blinded, Controlled Study of Tucatinib vs Placebo in Combination With Capecitabine and Trastuzumab in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma
Actual Study Start Date : January 28, 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Tucatinib in combination with capecitabine & trastuzumab
Tucatinib + capecitabine + trastuzumab
Drug: tucatinib
300 mg orally twice daily
Other Name: ONT-380, ARRY-380

Drug: capecitabine
1000 mg/m2 orally twice daily on Days 1-14 of each 21-day cycle
Other Name: Xeloda

Drug: trastuzumab
8 mg/kg intravenously (IV) on Day 1 of Cycle 1, followed by 6 mg/kg on Day1 of each 21-day cycle. In regions where approved, trastuzumab may be given at 600mg subcutaneously once every 3-weeks at either study initiation or crossing over from previous IV trastuzumab.
Other Name: Herceptin, Herceptin Hycleta

Active Comparator: Placebo in combination with capecitabine & trastuzumab
Placebo + capecitabine + trastuzumab
Drug: capecitabine
1000 mg/m2 orally twice daily on Days 1-14 of each 21-day cycle
Other Name: Xeloda

Drug: trastuzumab
8 mg/kg intravenously (IV) on Day 1 of Cycle 1, followed by 6 mg/kg on Day1 of each 21-day cycle. In regions where approved, trastuzumab may be given at 600mg subcutaneously once every 3-weeks at either study initiation or crossing over from previous IV trastuzumab.
Other Name: Herceptin, Herceptin Hycleta

Drug: placebo
Oral dose twice daily




Primary Outcome Measures :
  1. Progression-free survival (PFS) per RECIST 1.1 based on blinded independent central review (BICR) [ Time Frame: 48 months ]
    Defined as the time from randomization to documented disease progression or death from any cause, whichever occurs earlier


Secondary Outcome Measures :
  1. Progression-free survival (PFS) in patients with baseline brain metastases per RECIST 1.1 based on BICR [ Time Frame: 48 months ]
  2. Overall Survival (OS) [ Time Frame: 58 months ]
    Defined as time from randomization to death from any cause

  3. PFS per RECIST 1.1 based on investigator assessment [ Time Frame: 58 months ]
  4. Objective response rate (ORR) per RECIST 1.1 based on BICR [ Time Frame: 58 months ]
  5. Duration of response (DOR) per RECIST 1.1 based on BICR [ Time Frame: 58 months ]
    Defined as time from first documented response to documented disease progression or death from any cause, whichever occurs earlier

  6. Clinical benefit rate (CBR) [ Time Frame: 58 months ]
    As determined by BICR per RECIST 1.1

  7. Incidence of adverse events (AEs) [ Time Frame: 58 months ]
    As determined by assessment of AEs, clinical laboratory tests, and vital signs measurements

  8. Incidence of health resources utilization [ Time Frame: 58 months ]
  9. Quality of life as measured by EQ-5D-5L questionnaire [ Time Frame: 58 months ]
    Treatment and placebo group index values changes will be summarized

  10. Pharmacokinetic (PK) measure: Ctrough [ Time Frame: Up to 16 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Histologically confirmed HER2+ breast carcinoma, with HER2+ defined by in situ hybridization (ISH), immunohistochemistry (IHC), or fluorescence in situ hybridization (FISH) methodology
  • Received previous treatment with trastuzumab, pertuzumab, and T-DM1
  • Progression of unresectable locally advanced or metastatic breast cancer after last systemic therapy (as confirmed by investigator), or be intolerant of last systemic therapy
  • Have measurable or non-measurable disease assessable by RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Adequate hepatic and renal function and hematologic parameters
  • Left ventricular ejection fraction (LVEF) ≥ 50%
  • CNS Inclusion - Based on screening brain magnetic resonance imaging (MRI), patients must have one of the following:

    1. No evidence of brain metastases
    2. Untreated brain metastases not needing immediate local therapy
    3. Previously treated brain metastases not needing immediate local therapy

      1. Brain metastases previously treated with local therapy may either be stable since treatment or may have progressed since prior local CNS therapy
      2. Patients treated with CNS local therapy for newly identified lesions found on contrast brain MRI performed during screening for this study may be eligible to enroll if the following criteria are met:

        • Time since whole brain radiation therapy (WBRT) is ≥ 21 days prior to first dose of study treatment, time since stereotactic radiosurgery (SRS) is ≥ 7 days prior to first dose of study treatment, or time since surgical resection is ≥ 28 days.
        • Other sites of disease assessable by RECIST 1.1 are present
      3. Relevant records of any CNS treatment must be available to allow for classification of target and non-target lesions

Exclusion Criteria

  • Previously been treated with:

    1. lapatinib within 12 months of starting study treatment (except in cases where lapatinib was given for ≤ 21 days and was discontinued for reasons other than disease progression or toxicity)
    2. neratinib, afatinib, or other investigational HER2/epidermal growth factor receptor (EGFR) or HER2 tyrosine kinase inhibitor (TKI) at any time previously
    3. capecitabine (or other fluoropyrimidine) for metastatic disease except in cases where capecitabine was given for < 21 days and was discontinued for reasons other than disease progression or toxicity. Patients who have received capecitabine for adjuvant or neoadjuvant treatment at least 12 months prior to starting study treatment are eligible.
  • Clinically significant cardiopulmonary disease
  • Carriers of Hepatitis B or Hepatitis C or have other known chronic liver disease
  • Positive for human immunodeficiency virus (HIV)
  • Unable for any reason to undergo MRI of the brain
  • Have used a strong CYP3A4 or CYP2C8 inhibitor within 5 half-lives of the inhibitor, or a strong CYP3A4 or CYP2C8 inducer within 5 days prior to first dose of study treatment
  • Have known dihydropyrimidine dehydrogenase deficiency (DPD)
  • CNS Exclusion - Based on screening brain MRI, patients must not have any of the following:

    1. Any untreated brain lesions > 2.0 cm in size, unless approved by medical monitor
    2. Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of > 2 mg of dexamethasone (or equivalent)
    3. Any brain lesion thought to require immediate local therapy. Patients who undergo local treatment for such lesions identified by screening contrast brain MRI may still be eligible for the study based on criteria described under CNS inclusion criteria
    4. Known or suspected leptomeningeal disease (LMD)
    5. Poorly controlled seizures

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): NCT02614794


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Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
University of South Alabama - Mitchell Cancer Institute
Mobile, Alabama, United States, 36604
United States, Arizona
Cancer Treatment Centers of America - Phoenix
Goodyear, Arizona, United States, 85338
Arizona Oncology Associates, PC - HAL
Phoenix, Arizona, United States, 85016
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010-3000
TRIO - Central Regulatory Office
Los Angeles, California, United States, 90095
UCLA Medical Center / David Geffen School of Medicine
Los Angeles, California, United States, 90095
Torrance Memorial Physician Network - TRIO
Redondo Beach, California, United States, 90277
University of California at San Francisco
San Francisco, California, United States, 94134
Kaiser Permanente San Marcos Medical Offices
San Marcos, California, United States, 92078
Central Coast Medical Oncology Corporation TRIO
Santa Maria, California, United States, 93454
Kaiser Permanente Medical Center Northern California
Vallejo, California, United States, 94589
United States, Colorado
University of Colorado Hospital / University of Colorado
Aurora, Colorado, United States, 80045-0510
United States, Connecticut
Yale Cancer Center
New Haven, Connecticut, United States, 06520
United States, District of Columbia
Lombardi Cancer Center / Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Florida
Florida Cancer Specialists - South Region
Fort Myers, Florida, United States, 33901
Memorial Regional Hospital TRIO
Hollywood, Florida, United States, 33021
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States, 32207
Mount Sinai Medical Center / Florida
Miami Beach, Florida, United States, 33140
University of Miami
Miami, Florida, United States, 33136
Orlando Health, Inc. TRIO
Orlando, Florida, United States, 32806
Florida Cancer Specialists - North Region
Saint Petersburg, Florida, United States, 33705
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Florida Cancer Specialists - East West Palm Beach, FL (SCRI)
West Palm Beach, Florida, United States, 33401
United States, Georgia
Winship Cancer Institute / Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Northside Hospital
Atlanta, Georgia, United States, 30342
Augusta University
Augusta, Georgia, United States, 30912
Cancer Treatment Centers of America
Newnan, Georgia, United States, 30265
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
University of Chicago
Chicago, Illinois, United States, 60637-1470
Illinois Cancer Specialists / Advocate Lutheran General Hospital
Niles, Illinois, United States, 60714
Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Kansas
University of Kansas Cancer Center
Westwood, Kansas, United States, 66205
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
Maryland Oncology Hematology, P.A.
Rockville, Maryland, United States, 20850
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States, 55407
United States, Missouri
Saint Luke's Cancer Institute LLC
Kansas City, Missouri, United States, 64113
United States, Nebraska
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130
United States, New Hampshire
Dartmouth-Hitchcock Medical Center/ Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Mount Sinai Beth Israel
New York, New York, United States, 10003
New York University (NYU) Cancer Institute
New York, New York, United States, 10016
Stony Brook University Cancer Center
Stony Brook, New York, United States, 11794
United States, North Carolina
UNC Lineberger Comprehensive Cancer Center / University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Duke University Medical Center
Durham, North Carolina, United States, 27710
Leo W. Jenkins Cancer Services / Brody School of Medicine East Carolina University
Greenville, North Carolina, United States, 27834
United States, Ohio
James Cancer Hospital / Ohio State University
Columbus, Ohio, United States, 43210
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Oregon Health and Science University
Portland, Oregon, United States, 97239-3098
Northwest Cancer Specialists, P.C.
Tualatin, Oregon, United States, 97062
United States, Pennsylvania
University of Pennsylvania / Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
Cancer Treatment Centers of America / Eastern Regional Medical Center
Philadelphia, Pennsylvania, United States, 19124
United States, South Carolina
Roper St. Francis Healthcare
Charleston, South Carolina, United States, 29414
Medical University of South Carolina/Hollings Cancer Center
Charleston, South Carolina, United States, 29425
United States, Tennessee
Wellmont Cancer Institute
Kingsport, Tennessee, United States, 37660
Tennessee Oncology - Nashville
Nashville, Tennessee, United States, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37204
United States, Texas
Texas Oncology - Austin Midtown
Austin, Texas, United States, 78705
Texas Oncology Methodist
Dallas, Texas, United States, 75203
Texas Oncology - Denton South
Denton, Texas, United States, 76210
The Center for Cancer and Blood Disorders: Fortworth
Fort Worth, Texas, United States, 76104
Texas Oncology - Houston Memorial City
Houston, Texas, United States, 77024
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States, 77030-4095
Baylor Clinic
Houston, Texas, United States, 77030
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79410
Paris Regional Medical Center / US Oncology
Paris, Texas, United States, 75460
Texas Oncology - Plano East
Plano, Texas, United States, 75075
Texas Oncology - San Antonio Medical Center Northeast
San Antonio, Texas, United States, 78212
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
US Oncology Central Regulatory
The Woodlands, Texas, United States, 77380
Texas Oncology - Deke Slayton Cancer Center
Webster, Texas, United States, 77598
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
United States, Virginia
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
Shenandoah Oncology P.C.
Winchester, Virginia, United States, 22601
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Seattle Cancer Care Alliance / University of Washington
Seattle, Washington, United States, 98109-1023
United States, Wisconsin
Carbone Cancer Center / University of Wisconsin
Madison, Wisconsin, United States, 53792
Australia
Austin Hospital
Heidelberg, Australia, 3084
Cabrini Education and Research Precinct
Malvern, Australia, 3144
Peter MacCallum Cancer Centre
Melbourne, Australia, 3000
Breast Cancer Research Centre
Nedlands, Australia, 6009
Mater Hospital
North Sydney, Australia, 2060
Icon Cancer Care South Brisbane
South Brisbane, Australia, 4101
Mater Health Services
South Brisbane, Australia, 4101
Sunshine Hospital
St Albans, Australia, 3021
Westmead Hospital
Westmead, Australia, 2145
Austria
LKH- Universitat Klinikum Graz
Graz, Austria, 8036
Medizinische Universitat Innsbruck
Innsbruck, Austria, 6020
KH d. Barmherzigen Schwestern Linz
Linz, Austria, 4010
LKH Salzburg, Universitatsklinikum der PMU
Salzburg, Austria, 5020
Belgium
AZ Klina
Brasschaat, Belgium, 2930
Cliniques Universitaires Saint Luc
Brussels, Belgium, 1200
Grand Hopital de Charleroi
Charleroi, Belgium, 6000
Centre Hospitalier de l'Ardenne
Libramont, Belgium, 6800
CHU UCL Namur-Site de Saint Elisabeth
Namur, Belgium, 5000
Canada
Tom Baker Cancer Centre
Calgary, Canada, T2N 4N2
University of Alberta / Cross Cancer Institute
Edmonton, Canada, T6G 1Z2
Queen Elizabeth II Health Sciences Centre
Halifax, Canada, B3H 2Y9
Jewish General Hospital
Montreal, Canada, H3T 1E2
Hopital du Saint-Sacrement, CHU de Quebec-Universite Laval
Quebec, Canada, G1S 4L8
Allan Blair Cancer Centre
Regina, Canada, S4T7T1
Saskatoon Cancer Centre
Saskatoon, Canada, S7N 4H4
H. Bliss Murphy Cancer Centre
St John's, Canada, A1B 3V6
Sunnybrook Health Sciences Centre
Toronto, Canada, M4N 3M5
University Health Network, Princess Margaret Hospital
Toronto, Canada, M5G 2M9
British Columbia Cancer Agency - Vancouver Centre
Vancouver, Canada, V5Z 4E6
Czechia
Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie
Hradec Kralove, Czechia, 500 05
Fakultni Nemocnice Olomouc (Fnol) - Onkologicka Klinika
Olomouc, Czechia, 77520
Denmark
Aalborg Universitetshospital
Aalborg, Denmark, 9100
Rigs Hospiltalet
Copenhagen, Denmark, DK 2100
Herlev Hospital
Herlev, Denmark, 2730
Odense University Hospital
Odense C, Denmark, 5000
Sygehus Lillebaelt - Vejle Sygehus
Vejle, Denmark, 7100
France
University Hospital of Besancon
Besancon cedex, France, 25030
Clinique Victor Hugo
Le Mans, France, 72000
Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes
Lyon, France, 69373
Institut Paoli Calmettes
Marseille, France, 13273
Institute Curie - Centre de Lutte Contre Le Cancer CLCC de Paris
Paris, France, 75005
Centre Hospitalier Lyon Sud
Pierre Bénite Cedex, France, 69495
Institut Jean Godinot
REIMS Cedex, France, 51056
Centre Eugene Marquis
Rennes Cedex, France, 35042
Hopitaux Universitaires de Strasbourg
Strasbourg, France, 67200
Institut Claudius Regaud
Toulouse Cedex 9, France, 31059
CHU Tours - Hopital Bretonneau
TOURS Cedex 09, France, 37044
Germany
Charite Universitatsmedizin Berlin
Berlin, Germany, 10117
Kliniken Essen-Mitte - Evang. Huyssens-Stiftung
Essen, Germany, 45136
Universitaetsklinikum Hamburg-Eppendorf (UKE) - Onkologisches Zentrum - Interdisziplinaere Klinik und Poliklinik fuer Stammzelltransplantation
Hamburg, Germany, 20246
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Universitatsklinikum Schleswig-Holstein
Kiel, Germany, 24105
InVO- Institut fUr Versorgungsforschung in der onkologie GbR
Koblenz, Germany, 56068
Universitatsklinikum Koln
Köln, Germany, 50937
HOPE- Onkologisches Zentrum Rotkreuzklinikum
Munchen, Germany, 80639
Sana Klinikum Offenbach GmbH
Offenbach am Main, Germany, 63069
Israel
Rambam Health Corp.
Haifa, Israel, 31096
Hadassah Medical Center
Jerusalem, Israel, 91120
Meir Medical Center
Kfar Saba, Israel, 44281
Rabin Medical Center
Petach Tikva, Israel, 49414
Kaplan Medical Center
Rehovot, Israel, 76100
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Sheba Medical Center
Tel Hashomer, Israel, 52621
Italy
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
Bologna, Italy, 40138
Ospedale di Bolzano
Bolzano, Italy, 39100
Presido Ospedaliero- Senatore Antonio Perrino
Brindisi, Italy, 72100
Ospedale Ramazzini di Carpi
Carpi, Italy, 41012
Ospedale Policlinico San Martino
Genova, Italy, 16132
Istituto Europeo di Oncologia
Milano, Italy, 20141
IRCSS Policlinico San Matteo
Pavia, Italy, 27100
Azienda Ospedaliera S. Maria di Terni
Terni, Italy, 05100
A.O.U. - Ospedali Riuniti di Ancona
Torrette, Italy, 60126
Portugal
Hospital Cuf Descobertas R. Mario Botas Parque das Nacoes
Lisboa, Portugal, 1998-018
Centro Hospitalar do Porto - Hospital Santo Antonio
Porto, Portugal, 4099-001
Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 08035
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain, 08036
Hospital San Pedro de Alcantara
Caceres, Spain, 10002
Complejo Asistencial Universitario de Leon
Leon, Spain, 24008
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Son Espases
Palma de Mallorca, Spain, 07010
Hospital Clinico Univ De Santiago De Compostela
Santiago de Compostela, Spain, 15706
Hospital Arnau De Vilanova
Valencia, Spain, 46015
Hospital Clinico Universitario Lozano Blesa de Zaragoza
Zaragoza, Spain, 50009
Switzerland
Institute of Oncology of Southern Switzerland
Bellinzona, Switzerland, 6500
United Kingdom
Colchester Hospital University NHS Foundation Trust
Colchester, United Kingdom, C04 5JL
The Royal Marsden Hospital
London, United Kingdom, SW3 6JJ
Sarah Cannon Research Institute UK
London, United Kingdom, W1G 6AD
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Mount Vernon Hospital, UK
Northwood, United Kingdom, HA6 2RN
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom, NG5 1PD
Peterborough City Hospital
Peterborough, United Kingdom, PE3 9GZ
Weston Park Hospital- UK
Sheffield, United Kingdom, S10 2SJ
The Royal Marsden Hospital (Surrey)
Sutton, United Kingdom, SM2 5PT
Royal Cornwall Hospitals NHS Trust
Truro, United Kingdom, TR1 3LQ
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
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Study Director: Jorge Ramos, DO Seattle Genetics, Inc.
Study Director: Corinna Palanca-Wessels, MD, PhD Seattle Genetics, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT02614794     History of Changes
Other Study ID Numbers: ONT-380-206
2015-002801-12 ( EudraCT Number )
First Posted: November 25, 2015    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019

Keywords provided by Seattle Genetics, Inc.:
Tucatinib
Capecitabine
Trastuzumab
Xeloda
Herceptin
Breast Cancer
ARRY-380
ONT-380
HER2 Positive Breast Carcinoma
HER2 Positive Locally Advanced Breast Cancer
HER-2 Positive Breast Cancer
HER-2 Positive Breast Carcinoma
HER-2 Positive Locally Advanced Breast Cancer
Recurrent Breast Carcinoma
Stage IV Breast Cancer
Metastatic Breast Cancer
Breast Carcinoma
Metastatic Malignant Neoplasm in the Brain
Brain Metastases in Breast Cancer
Asymptomatic Brain Metastases in Breast Cancer
Low Symptomatic Brain Metastases in Breast Cancer

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Trastuzumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological