A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer
NCT ID: NCT02614794
Last Updated: 2023-08-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
612 participants
INTERVENTIONAL
2016-01-28
2022-08-11
Brief Summary
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There are two parts to this study. The first part of the study is already complete. Patients were randomly assigned to get either tucatinib or placebo (a pill with no medicine). Since this part was "blinded," neither patients nor their doctors knew whether a patient got tucatinib or placebo.
The second part of the study is called the Unblinded Phase. In this part of the study, participants and their doctors know which drugs are being given. Participants who used to get or are currently getting placebo may be able to start taking tucatinib instead.
Each treatment cycle lasts 21 days. Patients will swallow tucatinib 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.
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Detailed Description
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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).
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.
For the blinded phase, contrast brain MRI was performed at baseline. Efficacy assessments (CT of chest, abdomen and pelvis at a minimum) utilized RECIST 1.1 and included patients with evaluable tumors defined as measurable target lesions and non-measurable non-target lesions. RECIST assessment was performed at baseline, every 6 weeks for the first 24 weeks, and then every 9 weeks thereafter. Repeat MRI of the brain was required on this same schedule only in those patients with brain metastases identified at baseline. All treatment decisions were made based upon investigator assessment. All patients underwent a repeat MRI of the brain within 30 days of the end of treatment unless previously performed at time of disease progression.
For the unblinded phase, RECIST assessments will be performed per standard clinical practice as determined by investigator with a maximum interval of 12 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tucatinib in combination with capecitabine & trastuzumab
Tucatinib + capecitabine + trastuzumab
tucatinib
300 mg orally twice daily
capecitabine
1000 mg/m2 orally twice daily on Days 1-14 of each 21-day cycle
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.
Placebo in combination with capecitabine & trastuzumab
Placebo + capecitabine + trastuzumab
capecitabine
1000 mg/m2 orally twice daily on Days 1-14 of each 21-day cycle
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.
placebo
Oral dose twice daily
Interventions
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tucatinib
300 mg orally twice daily
capecitabine
1000 mg/m2 orally twice daily on Days 1-14 of each 21-day cycle
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.
placebo
Oral dose twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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:
i. 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.
ii. Other sites of disease assessable by RECIST 1.1 are present
4. Relevant records of any CNS treatment must be available to allow for classification of target and non-target lesions
4. Known or suspected leptomeningeal disease (LMD)
* Have measurable or non-measurable disease assessable by RECIST 1.1
* For patients who were randomized to the control arm and on the long-term follow-up period at the time of crossover screening: have 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 an ECOG Performance Status of 0 or 1
* Have a life expectancy of at least 6 months
* Have 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:
i. No evidence of brain metastases ii. Untreated brain metastases not needing immediate local therapy iii. Previously treated brain metastases not needing immediate local therapy
* Brain metastases previously treated with local therapy may either be stable since treatment or may have progressed since prior local CNS therapy
* 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:
1. 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.
* Known or suspected leptomeningeal disease (LMD)
* Poorly controlled seizures
Exclusion Criteria
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)
* Discontinuation of study treatment due to an adverse event while on the double-blind phase of the study. If the adverse event leading to discontinuation of study treatment has resolved, the patient may be allowed to crossover with approval from the medical monitor.
* History of exposure to the following cumulative doses of anthracyclines:
* Doxorubicin \> 360 mg/m\^2
* Epirubicin \> 720 mg/m\^2
* Mitoxantrone \> 120 mg/m\^2
* Idarubicin \> 90 mg/m\^2
* Liposomal doxorubicin \> 550 mg/m\^2
* History of allergic reactions to trastuzumab, capecitabine, or compounds chemically or biologically similar to tucatinib
o Exceptions for Grade 1 or 2 infusion related reactions to trastuzumab that were successfully managed, or known allergy to one of the excipients in the study drugs
* Have received treatment with any systemic anti-cancer therapy, non-CNS radiation, or experimental agent within 3 weeks prior to start of crossover therapy
* Any toxicity related to prior cancer therapies that has not resolved to ≤ Grade 1, with the following exceptions:
* Alopecia and neuropathy (must have resolved to ≤ Grade 2)
* CHF (must have been ≤ Grade 1 in severity at the time of occurrence and must have resolved completely)
* Anemia (must have resolved to ≤ Grade 2)
* Have clinically significant cardiopulmonary disease
* Have known myocardial infarction or unstable angina within 6 months prior to start of crossover therapy
* Require therapy with warfarin or other coumarin derivatives
* Inability to swallow pills or significant gastrointestinal disease which would preclude the adequate oral absorption of medications
* Have used a strong CYP2C8 inhibitor within 5 half-lives of the inhibitor or have used a strong CYP2C8 or CYP34A inducer within 5 days prior to start of the crossover (tucatinib) treatment.
* Known dihydropyrimidine dehydrogenase deficiency
* Unable to undergo contract MRI of the brain
* Have evidence within 2 years prior to start of crossover therapy of another malignancy that required systemic treatment
* CNS Exclusion:
* CNS Exclusion - Based on screening brain MRI, patients must not have any of the following:
* Any untreated brain lesions \> 2.0 cm in size, unless approved by medical monitor
* Ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of \> 2 mg of dexamethasone (or equivalent)
18 Years
ALL
No
Sponsors
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Seagen Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jorge Ramos, DO
Role: STUDY_DIRECTOR
Seagen Inc.
Corinna Palanca-Wessels, MD, PhD
Role: STUDY_DIRECTOR
Seagen Inc.
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of South Alabama - Mitchell Cancer Institute
Mobile, Alabama, United States
Cancer Treatment Centers of America - Phoenix
Goodyear, Arizona, United States
Arizona Oncology Associates, PC - HAL
Phoenix, Arizona, United States
City of Hope National Medical Center
Duarte, California, United States
TRIO - Central Regulatory Office
Los Angeles, California, United States
UCLA Medical Center / David Geffen School of Medicine
Los Angeles, California, United States
Torrance Memorial Physician Network - TRIO
Redondo Beach, California, United States
University of California at San Francisco
San Francisco, California, United States
Kaiser Permanente San Marcos Medical Offices
San Marcos, California, United States
Central Coast Medical Oncology Corporation TRIO
Santa Maria, California, United States
Kaiser Permanente Medical Center Northern California
Vallejo, California, United States
University of Colorado Hospital / University of Colorado
Aurora, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
Lombardi Cancer Center / Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Florida Cancer Specialists - South Region
Fort Myers, Florida, United States
Memorial Regional Hospital TRIO
Hollywood, Florida, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
Mount Sinai Medical Center / Florida
Miami Beach, Florida, United States
Orlando Health, Inc. TRIO
Orlando, Florida, United States
Florida Cancer Specialists - North Region
St. Petersburg, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Florida Cancer Specialists - East West Palm Beach, FL (SCRI)
West Palm Beach, Florida, United States
Winship Cancer Institute / Emory University School of Medicine
Atlanta, Georgia, United States
Northside Hospital
Atlanta, Georgia, United States
Augusta University
Augusta, Georgia, United States
Cancer Treatment Centers of America
Newnan, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Illinois Cancer Specialists / Advocate Lutheran General Hospital
Niles, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
University of Maryland
Baltimore, Maryland, United States
Maryland Oncology Hematology, P.A.
Rockville, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States
Saint Luke's Cancer Institute LLC
Kansas City, Missouri, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Dartmouth-Hitchcock Medical Center/ Norris Cotton Cancer Center
Lebanon, New Hampshire, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Mount Sinai Beth Israel
New York, New York, United States
New York University (NYU) Cancer Institute
New York, New York, United States
Stony Brook University Cancer Center
Stony Brook, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
UNC Lineberger Comprehensive Cancer Center / University of North Carolina
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Leo W. Jenkins Cancer Services / Brody School of Medicine East Carolina University
Greenville, North Carolina, United States
James Cancer Hospital / Ohio State University
Columbus, Ohio, United States
Providence Portland Medical Center
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Northwest Cancer Specialists, P.C.
Tualatin, Oregon, United States
University of Pennsylvania / Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Cancer Treatment Centers of America / Eastern Regional Medical Center
Philadelphia, Pennsylvania, United States
Roper St. Francis Healthcare
Charleston, South Carolina, United States
Medical University of South Carolina/Hollings Cancer Center
Charleston, South Carolina, United States
Wellmont Cancer Institute
Kingsport, Tennessee, United States
Tennessee Oncology - Nashville
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Oncology - Austin Midtown
Austin, Texas, United States
Texas Oncology Methodist
Dallas, Texas, United States
Texas Oncology - Denton South
Denton, Texas, United States
The Center for Cancer and Blood Disorders: Fortworth
Fort Worth, Texas, United States
Texas Oncology - Houston Memorial City
Houston, Texas, United States
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States
Baylor Clinic
Houston, Texas, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States
Paris Regional Medical Center / US Oncology
Paris, Texas, United States
Texas Oncology - Plano East
Plano, Texas, United States
Texas Oncology - San Antonio Medical Center Northeast
San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
US Oncology Central Regulatory
The Woodlands, Texas, United States
Texas Oncology - Deke Slayton Cancer Center
Webster, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States
Shenandoah Oncology P.C.
Winchester, Virginia, United States
Swedish Cancer Institute
Seattle, Washington, United States
Seattle Cancer Care Alliance / University of Washington
Seattle, Washington, United States
Carbone Cancer Center / University of Wisconsin
Madison, Wisconsin, United States
Austin Hospital
Heidelberg, , Australia
Cabrini Education and Research Precinct
Malvern, , Australia
Peter MacCallum Cancer Centre
Melbourne, , Australia
Breast Cancer Research Centre
Nedlands, , Australia
Mater Hospital
North Sydney, , Australia
Icon Cancer Care South Brisbane
South Brisbane, , Australia
Mater Health Services
South Brisbane, , Australia
Sunshine Hospital
St Albans, , Australia
Westmead Hospital
Westmead, , Australia
LKH- Universitat Klinikum Graz
Graz, , Austria
Medizinische Universitat Innsbruck
Innsbruck, , Austria
KH d. Barmherzigen Schwestern Linz
Linz, , Austria
LKH Salzburg, Universitatsklinikum der PMU
Salzburg, , Austria
AZ Klina
Brasschaat, , Belgium
Cliniques Universitaires Saint Luc
Brussels, , Belgium
Grand Hopital de Charleroi
Charleroi, , Belgium
Centre Hospitalier de l'Ardenne
Libramont, , Belgium
CHU UCL Namur-Site de Saint Elisabeth
Namur, , Belgium
Tom Baker Cancer Centre
Calgary, , Canada
University of Alberta / Cross Cancer Institute
Edmonton, , Canada
Queen Elizabeth II Health Sciences Centre
Halifax, , Canada
Jewish General Hospital
Montreal, , Canada
Hopital du Saint-Sacrement, CHU de Quebec-Universite Laval
Québec, , Canada
Allan Blair Cancer Centre
Regina, , Canada
Saskatoon Cancer Centre
Saskatoon, , Canada
H. Bliss Murphy Cancer Centre
St. John's, , Canada
Sunnybrook Health Sciences Centre
Toronto, , Canada
University Health Network, Princess Margaret Hospital
Toronto, , Canada
British Columbia Cancer Agency - Vancouver Centre
Vancouver, , Canada
Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie
Hradec Králové, , Czechia
Fakultni Nemocnice Olomouc (Fnol) - Onkologicka Klinika
Olomouc, , Czechia
Aalborg Universitetshospital
Aalborg, , Denmark
Rigs Hospiltalet
Copenhagen, , Denmark
Herlev Hospital
Herlev, , Denmark
Odense University Hospital
Odense C, , Denmark
Sygehus Lillebaelt - Vejle Sygehus
Vejle, , Denmark
University Hospital of Besancon
Besançon, , France
Clinique Victor Hugo
Le Mans, , France
Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes
Lyon, , France
Institut Paoli Calmettes
Marseille, , France
Institute Curie - Centre de Lutte Contre Le Cancer CLCC de Paris
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Institut Jean Godinot
Reims, , France
Centre Eugene Marquis
Rennes, , France
Hopitaux Universitaires de Strasbourg
Strasbourg, , France
Institut Claudius Regaud
Toulouse, , France
CHU Tours - Hopital Bretonneau
Tours, , France
Charite Universitatsmedizin Berlin
Berlin, , Germany
Universitatsklinikum Koln
Cologne, , Germany
Kliniken Essen-Mitte - Evang. Huyssens-Stiftung
Essen, , Germany
Universitaetsklinikum Hamburg-Eppendorf (UKE) - Onkologisches Zentrum - Interdisziplinaere Klinik und Poliklinik fuer Stammzelltransplantation
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitatsklinikum Schleswig-Holstein
Kiel, , Germany
InVO- Institut fUr Versorgungsforschung in der onkologie GbR
Koblenz, , Germany
HOPE- Onkologisches Zentrum Rotkreuzklinikum
München, , Germany
Sana Klinikum Offenbach GmbH
Offenbach, , Germany
Rambam Health Corp.
Haifa, , Israel
Hadassah Medical Center
Jerusalem, , Israel
Meir Medical Center
Kfar Saba, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Kaplan Medical Center
Rehovot, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Sheba Medical Center
Tel Litwinsky, , Israel
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
Bologna, , Italy
Ospedale di Bolzano
Bolzano, , Italy
Presido Ospedaliero- Senatore Antonio Perrino
Brindisi, , Italy
Ospedale Ramazzini di Carpi
Carpi, , Italy
Ospedale Policlinico San Martino
Genova, , Italy
Istituto Europeo di Oncologia
Milan, , Italy
IRCSS Policlinico San Matteo
Pavia, , Italy
Azienda Ospedaliera S. Maria di Terni
Terni, , Italy
A.O.U. - Ospedali Riuniti di Ancona
Torrette, , Italy
Hospital Cuf Descobertas R. Mario Botas Parque das Nacoes
Lisbon, , Portugal
Centro Hospitalar do Porto - Hospital Santo Antonio
Porto, , Portugal
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, , Spain
Hospital San Pedro de Alcantara
Cáceres, , Spain
Complejo Asistencial Universitario de Leon
León, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Son Espases
Palma de Mallorca, , Spain
Hospital Clinico Univ De Santiago De Compostela
Santiago de Compostela, , Spain
Hospital Arnau De Vilanova
Valencia, , Spain
Hospital Clinico Universitario Lozano Blesa de Zaragoza
Zaragoza, , Spain
Institute of Oncology of Southern Switzerland
Bellinzona, , Switzerland
Colchester Hospital University NHS Foundation Trust
Colchester, , United Kingdom
The Royal Marsden Hospital
London, , United Kingdom
Sarah Cannon Research Institute UK
London, , United Kingdom
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Mount Vernon Hospital, UK
Northwood, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Peterborough City Hospital
Peterborough, , United Kingdom
Weston Park Hospital- UK
Sheffield, , United Kingdom
The Royal Marsden Hospital (Surrey)
Sutton, , United Kingdom
Royal Cornwall Hospitals NHS Trust
Truro, , United Kingdom
Countries
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References
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Dai L, Gao T, Guo R, Chen Y, Wang J, Zhou S, Tang Y, Chen D, Huang S. Efficacy and safety of pyrotinib-based regimens in HER2 positive metastatic breast cancer: A retrospective real-world data study. Neoplasia. 2024 Oct;56:101029. doi: 10.1016/j.neo.2024.101029. Epub 2024 Jul 17.
Lin NU, Murthy RK, Abramson V, Anders C, Bachelot T, Bedard PL, Borges V, Cameron D, Carey LA, Chien AJ, Curigliano G, DiGiovanna MP, Gelmon K, Hortobagyi G, Hurvitz SA, Krop I, Loi S, Loibl S, Mueller V, Oliveira M, Paplomata E, Pegram M, Slamon D, Zelnak A, Ramos J, Feng W, Winer E. Tucatinib vs Placebo, Both in Combination With Trastuzumab and Capecitabine, for Previously Treated ERBB2 (HER2)-Positive Metastatic Breast Cancer in Patients With Brain Metastases: Updated Exploratory Analysis of the HER2CLIMB Randomized Clinical Trial. JAMA Oncol. 2023 Feb 1;9(2):197-205. doi: 10.1001/jamaoncol.2022.5610.
Mueller V, Wardley A, Paplomata E, Hamilton E, Zelnak A, Fehrenbacher L, Jakobsen E, Curtit E, Boyle F, Harder Brix E, Brenner A, Crouzet L, Ferrario C, Munoz-Mateu M, Arkenau HT, Iqbal N, Aithal S, Block M, Cold S, Cancel M, Hahn O, Poosarla T, Stringer-Reasor E, Colleoni M, Cameron D, Curigliano G, Siadak M, DeBusk K, Ramos J, Feng W, Gelmon K. Preservation of quality of life in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer treated with tucatinib or placebo when added to trastuzumab and capecitabine (HER2CLIMB trial). Eur J Cancer. 2021 Aug;153:223-233. doi: 10.1016/j.ejca.2021.05.025. Epub 2021 Jun 29.
Lin NU, Borges V, Anders C, Murthy RK, Paplomata E, Hamilton E, Hurvitz S, Loi S, Okines A, Abramson V, Bedard PL, Oliveira M, Mueller V, Zelnak A, DiGiovanna MP, Bachelot T, Chien AJ, O'Regan R, Wardley A, Conlin A, Cameron D, Carey L, Curigliano G, Gelmon K, Loibl S, Mayor J, McGoldrick S, An X, Winer EP. Intracranial Efficacy and Survival With Tucatinib Plus Trastuzumab and Capecitabine for Previously Treated HER2-Positive Breast Cancer With Brain Metastases in the HER2CLIMB Trial. J Clin Oncol. 2020 Aug 10;38(23):2610-2619. doi: 10.1200/JCO.20.00775. Epub 2020 May 29.
Murthy RK, Loi S, Okines A, Paplomata E, Hamilton E, Hurvitz SA, Lin NU, Borges V, Abramson V, Anders C, Bedard PL, Oliveira M, Jakobsen E, Bachelot T, Shachar SS, Muller V, Braga S, Duhoux FP, Greil R, Cameron D, Carey LA, Curigliano G, Gelmon K, Hortobagyi G, Krop I, Loibl S, Pegram M, Slamon D, Palanca-Wessels MC, Walker L, Feng W, Winer EP. Tucatinib, Trastuzumab, and Capecitabine for HER2-Positive Metastatic Breast Cancer. N Engl J Med. 2020 Feb 13;382(7):597-609. doi: 10.1056/NEJMoa1914609. Epub 2019 Dec 11.
Murthy R, Borges VF, Conlin A, Chaves J, Chamberlain M, Gray T, Vo A, Hamilton E. Tucatinib with capecitabine and trastuzumab in advanced HER2-positive metastatic breast cancer with and without brain metastases: a non-randomised, open-label, phase 1b study. Lancet Oncol. 2018 Jul;19(7):880-888. doi: 10.1016/S1470-2045(18)30256-0. Epub 2018 May 24.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-002801-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ONT-380-206
Identifier Type: -
Identifier Source: org_study_id
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