Last updated on April 2019

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


Brief description of study

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.

Detailed Study 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.

Clinical Study Identifier: NCT02614794

Contact Investigators or Research Sites near you

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Arizona Oncology Associates

Glendale, AZ United States
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City of Hope

Duarte, CA United States
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Torrance Health Association

Redondo Beach, CA United States
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Kaiser Permanente

Vallejo, CA United States
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Yale Cancer Center

New Haven, CT United States
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Stamford Hospital

Stamford, CT United States
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Memorial Regional Hospital

Hollywood, FL United States
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Orlando Health, Inc.

Orlando, FL United States
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Florida Cancer Specialists

West Palm Beach, FL United States
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Northside Hospital, Inc.

Atlanta, GA United States
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Carle Cancer Center

Urbana, IL United States
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University of Kansas

Westwood, KS United States
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Louisiana State University

New Orleans, LA United States
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Maryland Oncology Hematology, PA

Silver Spring, MD United States
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Henry Ford Hospital

Detroit, MI United States
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William Beaumont Hospital

Royal Oak, MI United States
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Virginia Piper Cancer Institute

Minneapolis, MN United States
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Hunterdon Medical Center (HMC)

Flemington, NJ United States
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Mount Sinai - Beth Israel

New York, NY United States
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UNC Chapel Hill

Chapel Hill, NC United States
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East Carolina University (ECU)

Greenville, NC United States
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Kinston Medical Specialists

Kinston, NC United States
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Oncology Hematology Care

Cincinnati, OH United States
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Providence Cancer Center

Portland, OR United States
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University of Pennsylvania (UPenn)

Philadelphia, PA United States
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Roper St. Francis

Charleston, SC United States
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Wellmont Cancer Institute

Kingsport, TN United States
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Vanderbilt University

Nashville, TN United States
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Texas Oncology Methodist

Dallas, TX United States
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Baylor College of Medicine

Houston, TX United States
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Virginia Cancer Specialist

Arlington, VA United States
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Swedish Medical Center

Issaquah, WA United States
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Mater Hospital

Sydney, Australia
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Westmead Hospital

Westmead, Australia
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Icon Cancer Care

South Brisbane, Australia
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Mater Health Services

South Brisbane, Australia
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Austin Hospital

Heidelberg, Australia
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Bliss Cancer Centre

St. John's, NL Canada
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Peterborough District Hospital

Peterborough, United Kingdom
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Sarah Cannon Research

London, United Kingdom
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The Royal Marsden

Sutton, United Kingdom
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St. Luke's Hospital

Kansas City, MO United States
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Rigshospitalet

Copenhagen, Denmark
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Weston Park Hospital

Sheffield, United Kingdom
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Mount Vernon Hospital

Northwood, United Kingdom
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Compass Oncology

Vancouver, WA United States
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AZ Klina

Brasschaat, Belgium
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UCL St Luc

Brussels, Belgium
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John Theurer Cancer Center

Hackensack, NJ United States
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Shenandoah Oncology

Winchester, VA United States
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Colchester General Hospital

Colchester, United Kingdom
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Fn Hradec Kralove

Hradec Králové, Czechia
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Recruitment Status: Open


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