A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer
Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Subjects With Unresectable Locally-advanced or Metastatic HER2+ Breast Cancer (HER2CLIMB-02)
3 other identifiers
interventional
466
19 countries
482
Brief Summary
This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone 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. 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. All patients in the study will get T-DM1, a drug that is often used to treat this cancer. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. Patients will get T-DM1 injections from the study site staff on the first day of every cycle.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2019
Longer than P75 for phase_3
482 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2019
CompletedFirst Posted
Study publicly available on registry
June 5, 2019
CompletedStudy Start
First participant enrolled
October 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 29, 2023
CompletedResults Posted
Study results publicly available
July 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2029
ExpectedMarch 30, 2026
March 1, 2026
3.7 years
June 4, 2019
June 25, 2024
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1 Based on Investigator Assessment
PFS as per investigator was defined as the time from the date of randomization to the investigator assessment of disease progression (PD) as per RECIST v1.1 or death from any cause, whichever occurred first. PD: at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimiter (mm). Participants without documentation of PD, or death at the time of analysis were censored at the date of the last tumor assessment.
From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to 43 months)
Secondary Outcomes (12)
Overall Survival (OS)
Up to approximately 5 years
Progression-Free Survival as Per RECIST v1.1 in Participants With Brain Metastases at Baseline Based on Investigator Assessment
From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to 45 months)
Objective Response Rate (ORR) as Per RECIST v1.1 Based on Investigator Assessment
From the date of first CR or PR until the date of the first documentation of PD or death, whichever occurred first (maximum up to 43 months)
Overall Survival in Participants With Brain Metastases at Baseline
Up to approximately 5 years
Progression-Free Survival as Per RECIST v1.1 Determined by Blinded Independent Committee Review (BICR)
From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to 43 months)
- +7 more secondary outcomes
Study Arms (2)
Tucatinib + T-DM1
EXPERIMENTALTucatinib + T-DM1
Placebo + T-DM1
ACTIVE COMPARATORPlacebo + T-DM1
Interventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed HER2+ breast carcinoma as determined by a sponsor-designated central laboratory
- History of prior treatment with a taxane and trastuzumab in any setting, separately or in combination
- Have progression of unresectable locally advanced/metastatic breast cancer after last systemic therapy, or be intolerant of last systemic therapy
- Measurable or non-measurable disease assessable by RECIST v1.1
- ECOG performance status score of 0 or 1
- (a) No evidence of brain metastases
- (b) Untreated brain metastases not needing immediate local therapy
- (c) Previously treated brain metastases
- Brain metastases previously treated with local therapy may either be stable since treatment or may have progressed since prior local CNS therapy, provided that there is no clinical indication for immediate re-treatment with local therapy
- Participants treated with CNS local therapy for newly identified lesions or previously treated and progressing lesions may be eligible to enroll if all of the following criteria are met:
- (i) Time since SRS is at least 7 days prior to first dose of study treatment, time since WBRT is at least 14 days prior to first dose, or time since surgical resection is at least 28 days.
- (ii) Other sites of evaluable disease are present
- Relevant records of any CNS treatment must be available to allow for classification of target and non-target lesions
You may not qualify if:
- Prior treatment with tucatinib, afatinib, trastuzumab deruxtecan (DS-8201a), or any other investigational anti-HER2, anti-EGFR, or HER2 TKI agent. Prior treatment with lapatinib or neratinib within 12 months of starting study treatment (except in cases where they were given for ≤21 days and was discontinued for reasons other than disease progression or severe toxicity). Prior treatment with pyrotinib for recurrent of mBC (except in cases where pyrotinib was given for ≤21 days and was discontinued for reasons other than disease progression or severe toxicity).
- Any untreated brain lesions \>2 cm in size
- Ongoing use of corticosteroids for control of symptoms of brain metastases at a total daily dose of \>2 mg of dexamethasone (or equivalent).
- Any brain lesion thought to require immediate local therapy
- Known or concurrent leptomeningeal disease as documented by the investigator
- Poorly controlled generalized or complex partial seizures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (486)
University of South Alabama Health Children's and Women's Hospital
Mobile, Alabama, 36604, United States
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, 36604, United States
University of South Alabama Health University Hospital
Mobile, Alabama, 36617, United States
Banner Gateway Medical Center
Gilbert, Arizona, 85234, United States
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234, United States
Western Regional Medical Center, LLC
Goodyear, Arizona, 85338, United States
Arizona Oncology Associates, PC - HOPE.
Tucson, Arizona, 85704, United States
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, 85704, United States
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, 85711, United States
UCLA Hematology/Oncology - Alhambra
Alhambra, California, 91801, United States
Kaiser Permanente Medical Center Lab Drawing Station
Antioch, California, 94509, United States
Kaiser Permanente Medical Center Lab Drawing Station
Antioch, California, 94531, United States
UCLA Hematology/Oncology- Beverly Hills
Beverly Hills, California, 90212, United States
UC Irvine Health Cancer Center - Newport
Costa Mesa, California, 92627, United States
City of Hope Investigational Drug Services (IDS)
Duarte, California, 91010, United States
City of Hope(City of Hope National Medical Center,City of Hope Medical Center)
Duarte, California, 91010, United States
Kaiser Permanente Medical Center (Radiology)
Dublin, California, 94568, United States
UCLA Hematology/Oncology - Encino
Encino, California, 91436, United States
Kaiser Permanente Medical Center Lab Drawing Station
Fairfield, California, 94533, United States
Kaiser Permanente Medical Center Lab Drawing Station
Gilroy, California, 95020, United States
UCLA Hematology/Oncology- Irvine
Irvine, California, 92604, United States
Drug Management Only: UCLA West Medical Pharmacy, Attn: Steven L Wong, Pharm.D.
Los Angeles, California, 90095, United States
Regulatory Management only: TRIO-US Central Administration
Los Angeles, California, 90095, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095, United States
UCLA Hematology/Oncology
Los Angeles, California, 90095, United States
UCLA West Medical Pharmacy
Los Angeles, California, 90095, United States
Kaiser Permanente Medical Center Lab Drawing Station
Martinez, California, 94553, United States
Kaiser Permanente Medical Center Lab Drawing Station
Milpitas, California, 95035, United States
Kaiser Permanente Medical Center Lab Drawing Station
Modesto, California, 95356, United States
Kaiser Permanente Medical Center Lab Drawing Station
Mountain View, California, 94041, United States
Kaiser Permanente Medical Center Lab Drawing Station
Napa, California, 94558, United States
Kaiser Permanente Medical Center (clinic+DSL)
Oakland, California, 94611, United States
Kaiser Permanente Medical Center (Radiology)
Oakland, California, 94611, United States
Chao Family Comprehensive Cancer Center University of California Irvine
Orange, California, 92868, United States
UC Irvine Medical Center Attn: Trisha Maris
Orange, California, 92868, United States
UCI Medical Center - Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
Kaiser Permanente Medical Center Lab Drawing Station
Pleasanton, California, 94588, United States
UCLA Hematology/Oncology - Porter Ranch
Porter Ranch, California, 91326, United States
Kaiser Permanente Medical Center Lab Drawing Station
Redwood City, California, 94063, United States
Kaiser Permanente Medical Center (clinic+DSL)
Roseville, California, 95661, United States
Kaiser Permanente Sacramento J Street Medical Center (clinic+DSL+Lab Drawing Station)
Sacramento, California, 95814, United States
University of California Davis Medical Center
Sacramento, California, 95817, United States
University of California Davis
Sacramento, California, 95817, United States
Kaiser Permanente Medical Center (Radiology)
Sacramento, California, 95825, United States
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110, United States
Kaiser Permanente Medical Center (clinic+DSL)
San Francisco, California, 94115, United States
University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center.
San Francisco, California, 94158, United States
Kaiser Permanente Mission Bay Medical Center Lab Drawing Station
San Francisco, California, 94518, United States
Kaiser Permanente Medical Center Lab Drawing Station
San Jose, California, 95110, United States
Kaiser Permanente Medical Center (clinic+DSL)
San Jose, California, 95119, United States
Kaiser Permanente Medical Center (clinic+DSL)
San Leandro, California, 94577, United States
UCLA Hematology/Oncology - San Luis Obispo
San Luis Obispo, California, 93401, United States
Kaiser Permanente Medical Center (clinic+DSL)
Santa Clara, California, 95051, United States
UCLA Hematology/Oncology - Santa Monica
Santa Monica, California, 90404, United States
UCLA Hematology/Oncology Parkside
Santa Monica, California, 90404, United States
Kaiser Permanente Medical Center (clinic+DSL)
South San Francisco, California, 94080, United States
Torrance Memorial Physician Network - Cancer Care
Torrance, California, 90505, United States
Torrance Memorial Physician Network-Cancer Care
Torrance, California, 90505, United States
UCLA Torrance Oncology
Torrance, California, 90505, United States
UCLA Hematology/Oncology - Santa Clarita
Valencia, California, 91355, United States
Kaiser Permanente Medical Center (clinic+DSL)
Vallejo, California, 94589, United States
UCLA Hematology/Oncology - Ventura
Ventura, California, 93003, United States
Kaiser Permanente Medical Center (clinic+DSL)
Walnut Creek, California, 94596, United States
Rocky Mountain Cancer Centers, LLP
Aurora, Colorado, 80012, United States
Clinical and Translational Research Center (CTRC)
Aurora, Colorado, 80045, United States
University of Colorado Hospital - Anschutz Cancer Pavilion(ACP)
Aurora, Colorado, 80045, United States
University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
Aurora, Colorado, 80045, United States
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
Aurora, Colorado, 80045, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Rocky Mountain Cancer Centers, LLP
Boulder, Colorado, 80303, United States
Rocky Mountain Cancer Centers, LLP
Centennial, Colorado, 80112, United States
Rocky Mountain Cancer Centers, LLP
Colorado Springs, Colorado, 80907, United States
UCH-MHS Memorial Hospital Central
Colorado Springs, Colorado, 80909, United States
Printers Park Medical Plaza
Colorado Springs, Colorado, 80910, United States
Briargate Medical Campus
Colorado Springs, Colorado, 80920, United States
UCH-MHS Memorial Hospital North
Colorado Springs, Colorado, 80920, United States
UCHealth Cherry Creek Medical Center
Denver, Colorado, 80206, United States
UCHealth IDS Research Pharmacy - Cherry Creek
Denver, Colorado, 80206, United States
Cancer Centers of Colorado at Saint Joseph Hospital
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, 80218, United States
SCL Health Saint Joseph Hospital
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, 80220, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Cancer Care & Hematology - Fort Collins
Fort Collins, Colorado, 80528, United States
Cancer Care & Hematology - Greeley
Greeley, Colorado, 80634, United States
SCL Health Good Samaritan Medical Center Cancer Centers of Colorado
Lafayette, Colorado, 80026, United States
SCL Health Good Samaritan Medical Center
Lafayette, Colorado, 80026, United States
Rocky Mountain Cancer Centers, LLP
Lakewood, Colorado, 80228, United States
Rocky Mountain Cancer Centers, LLP
Littleton, Colorado, 80120, United States
Rocky Mountain Cancer Centre, LLP
Lone Tree, Colorado, 80124, United States
Cancer Care & Hematology - Loveland
Loveland, Colorado, 80538, United States
Rocky Mountain Cancer Centers, LLP
Thornton, Colorado, 80260, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Washington Cancer Institute at MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Florida Cancer Specialists
Altamonte Springs, Florida, 32701, United States
Florida Cancer Specialists
Bonita Springs, Florida, 34135, United States
Florida Cancer Specialists
Brandon, Florida, 33511, United States
Florida Cancer Specialists
Cape Coral, Florida, 33909, United States
Florida Cancer Specialists
Clearwater, Florida, 33761, United States
Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center
Coral Gables, Florida, 33146, United States
Florida Cancer Specialists.
Daytona Beach, Florida, 32117, United States
Sylvester Comprehensive Cancer Center- Deerfield Beach
Deerfield Beach, Florida, 33442, United States
Florida Cancer Specialists - South Region
Fort Myers, Florida, 33901, United States
Florida Cancer Specialists
Fort Myers, Florida, 33905, United States
Florida Cancer Specialists
Fort Myers, Florida, 33908, United States
Florida Cancer Specialists
Gainesville, Florida, 32605, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207, United States
Florida Cancer Specialists
Largo, Florida, 33770, United States
Florida Cancer Specialists
Lecanto, Florida, 34461, United States
Bascom Palmer Eye Institute
Miami, Florida, 33136, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, 33176, United States
Sylvester Comprehensive Cancer Center Kendall
Miami, Florida, 33176, United States
Florida Cancer Specialists
Naples, Florida, 34102, United States
Florida Cancer Specialists
Ocala, Florida, 34474, United States
AdventHealth Orlando
Orlando, Florida, 32803, United States
AdventHealth Hematology and Oncology
Orlando, Florida, 32804, United States
AdventHealth Medical Group Orlando
Orlando, Florida, 32804, United States
AdventHealth Orlando Infusion Center
Orlando, Florida, 32804, United States
AdventHealth Orlando, Investigational Drug Services
Orlando, Florida, 32804, United States
Florida Cancer Specialists
Orlando, Florida, 32806, United States
Orlando Health, Inc. TRIO
Orlando, Florida, 32806, United States
Sylvester Comprehensive Cancer Center Plantation
Plantation, Florida, 33324, United States
Florida Cancer Specialists
Port Charlotte, Florida, 33980, United States
Florida Cancer Specialists
Sarasota, Florida, 34236, United States
Florida Cancer Specialists - North Region
St. Petersburg, Florida, 33705, United States
Florida Cancer Specialists
St. Petersburg, Florida, 33705, United States
Florida Cancer Specialists.
Stuart, Florida, 34994, United States
Florida Cancer Specialists
Tampa, Florida, 33607, United States
Moffitt Cancer Center, Richard M, Schulze Family Foundation Outpatient Center at McKinley Campus
Tampa, Florida, 33612, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Moffitt McKinley Hospital
Tampa, Florida, 33612, United States
Florida Cancer Specialists
Tavares, Florida, 32778, United States
Florida Cancer Specialists
The Villages, Florida, 32159, United States
Florida Cancer Specialists
Trinity, Florida, 34655, United States
Florida Cancer Specialists.
Vero Beach, Florida, 32960, United States
Florida Cancer Specialists.
Wellington, Florida, 33414, United States
Florida Cancer Specialists.
West Palm Beach, Florida, 33401, United States
Northside Hospital, Inc. - GCS/ Athens
Athens, Georgia, 30606, United States
Winship Cancer Institute, Emory University.
Atlanta, Georgia, 30322, United States
Atlanta Cancer Care - Atlanta
Atlanta, Georgia, 30342, United States
Northside Hospital, Inc. - Central Research Department
Atlanta, Georgia, 30342, United States
Northside Hospital, Inc. - GCS/Northside
Atlanta, Georgia, 30342, United States
Georgia Cancer Center at Augusta University
Augusta, Georgia, 30912, United States
Northside Hospital, Inc. - GCS/Blairsville
Blairsville, Georgia, 30512, United States
Northside Hospital, Inc. - GCS/Canton
Canton, Georgia, 30115, United States
Atlanta Cancer Care - Cumming
Cumming, Georgia, 30041, United States
Northside Hospital, Inc. - GCS/Macon
Macon, Georgia, 31217, United States
Northside Hospital, Inc. - GCS/Kennestone
Marietta, Georgia, 30060, United States
Hawai'i Pacific Health Research Institute - Administrative Site
Honolulu, Hawaii, 96813, United States
Kaiser Permanente Hawaii.
Honolulu, Hawaii, 96819, United States
Kaiser Permanente Hawaii
Honolulu, Hawaii, 96819, United States
Kapi'olani Medical Center for Women and Children
Honolulu, Hawaii, 96826, United States
Kapi'olani Women's Center
Honolulu, Hawaii, 96826, United States
Illinois CancerCare- Bloomington
Bloomington, Illinois, 61704, United States
Rush University Medical Center, Professional Office Building Infusion Pharmacy
Chicago, Illinois, 60612, United States
Rush University Medical Center.
Chicago, Illinois, 60612, United States
University of Chicago Medical Center, CCD- Investigational Drug Service Pharmacy
Chicago, Illinois, 60637, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Illinois CancerCare - Galesburg
Galesburg, Illinois, 61401, United States
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
New Lenox, Illinois, 60451, United States
Orland Park - University of Chicago Center for Advanced Care
Orland Park, Illinois, 60462, United States
Illinois CancerCare- Pekin
Pekin, Illinois, 61554, United States
Illinois CancerCare, P.C.
Peoria, Illinois, 61615, United States
Illinois CancerCare- Peru
Peru, Illinois, 61354, United States
Ft Wayne Medical Oncology and Hematology, Inc TRIO
Fort Wayne, Indiana, 46804, United States
The University of Kansas Cancer Center - West
Kansas City, Kansas, 66112, United States
MidAmerica Division, Inc. c/o Menorah Medical Center
Overland Park, Kansas, 66209, United States
The University of Kansas Cancer Center - Overland Park
Overland Park, Kansas, 66210, United States
The University of Kansas Cancer Center - Indian Creek Campus
Overland Park, Kansas, 66211, United States
The University of Kansas Cancer Center Breast Surgery Center - Indian Creek Campus
Overland Park, Kansas, 66211, United States
The University of Kansas Cancer Center, Investigational Drug Services
Westwood, Kansas, 66205, United States
The University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
CHI Saint Joseph Cancer Care
Lexington, Kentucky, 40509, United States
Saint Joseph Health Infusion Services
Lexington, Kentucky, 40509, United States
University of Maryland, Greenebaum Comprehensive Cancer Center.
Baltimore, Maryland, 21201, United States
Mercy Medical Center -Weinberg Center
Baltimore, Maryland, 21202, United States
Mercy Medical Center.
Baltimore, Maryland, 21202, United States
Maryland Oncology Hematology, P.A
Bethesda, Maryland, 20817, United States
Maryland Oncology Hematology, P.A
Brandywine, Maryland, 20613, United States
Maryland Oncology Hematology, P.A
Columbia, Maryland, 21044, United States
Maryland Oncology Hematology, P.A
Frederick, Maryland, 21702, United States
Maryland Oncology Hematology, P.A
Largo, Maryland, 20774, United States
Maryland Oncology Hematology, P.A
Rockville, Maryland, 20850, United States
Maryland Oncology Hematology, P.A
Silver Spring, Maryland, 20904, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute- Chestnut Hill
Newton, Massachusetts, 02459, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Brighton Center for Specialty Care
Brighton, Michigan, 48116, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Minnesota Oncology Hematology, P.A.
Edina, Minnesota, 55435, United States
Siteman Cancer Center - St Peters
City of Saint Peters, Missouri, 63376, United States
Siteman Cancer Center - West County
Creve Coeur, Missouri, 63141, United States
Siteman Cancer Center - North County
Florissant, Missouri, 63031, United States
MidAmerica Division, Inc. c/o Centerpoint Medical Center
Independence, Missouri, 64057, United States
Saint Luke's Cancer institute
Kansas City, Missouri, 64111, United States
Saint Luke's Hospital Investigational Pharmacy
Kansas City, Missouri, 64111, United States
The University of Kansas Cancer Center
Kansas City, Missouri, 64116, United States
MidAmerica Division, Inc., c/o Research Medical Center
Kansas City, Missouri, 64132, United States
The University of Kansas Cancer Center -North
Kansas City, Missouri, 64154, United States
The University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Washington University School of Medicine - Siteman Cancer Center.
St Louis, Missouri, 63110, United States
Washington University School of Medicine - St. Louis
St Louis, Missouri, 63110, United States
Siteman Cancer Center - South County
St Louis, Missouri, 63129, United States
St. Vincent Healthcare
Billings, Montana, 59101, United States
St. Vincent - Frontier Cancer Center
Billings, Montana, 59102, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha, Nebraska, 68114, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha, Nebraska, 68124, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha, Nebraska, 68130, United States
West Omaha Imaging
Omaha, Nebraska, 68130, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89074, United States
Comprehensive Cancer Centers of Nevada Research Department
Henderson, Nevada, 89119, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89128, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89144, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169, United States
Summit Medical Group
Berkeley Heights, New Jersey, 07922, United States
Summit Medical Group
Florham Park, New Jersey, 07932, United States
Cooperman Barnabas Medical Center
Livingston, New Jersey, 07039, United States
New York Oncology Hematology, P.C.
Albany, New York, 12206, United States
Stony Brook Advanced Imaging
Stony Brook, New York, 11794, United States
Stony Brook Cancer Center
Stony Brook, New York, 11794, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
Carolinas Medical Center (biopsy only)
Charlotte, North Carolina, 28203, United States
Charlotte Radiology Medical Center Plaza Breast Center (biopsy only)
Charlotte, North Carolina, 28203, United States
Carolinas Medical Center Investigational Drug Services
Charlotte, North Carolina, 28204, United States
Levine Cancer Institute
Charlotte, North Carolina, 28204, United States
Carolinas Medical Center - Mercy (biopsy only)
Charlotte, North Carolina, 28207, United States
Atrium Health Pineville (biopsy only)
Charlotte, North Carolina, 28210, United States
Levine Cancer Institute-Pineville
Charlotte, North Carolina, 28210, United States
Atrium Health University City (biopsy only)
Charlotte, North Carolina, 28262, United States
Atrium Health Cabarrus (biopsy only)
Concord, North Carolina, 28025, United States
Levine Cancer Institute Concord
Concord, North Carolina, 28025, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Atrium Health Union (biopsy only)
Monroe, North Carolina, 28112, United States
OHSU Knight Cancer Institute, Beaverton
Beaverton, Oregon, 97006, United States
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon, 97015, United States
OHSU Knight Cancer Institute, Gresham
Gresham, Oregon, 97030, United States
OHSU Knight Cancer Institute, Northwest Portland
Portland, Oregon, 97210, United States
Northwest Cancer Specialists P.C.
Portland, Oregon, 97213, United States
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
OHSU Knight Cancer Institute, East Portland
Portland, Oregon, 97216, United States
Northwest Cancer Specialists P.C.
Portland, Oregon, 97227, United States
OHSU Center for Health and Healing 2
Portland, Oregon, 97239, United States
OHSU Center for Health and Healing
Portland, Oregon, 97239, United States
OHSU Research Pharmacy Services
Portland, Oregon, 97239, United States
Oregon Health And Science University
Portland, Oregon, 97239, United States
Northwest Cancer Specialists, P.C.
Tigard, Oregon, 97223, United States
OHSU Knight Cancer Institute, Tualatin
Tualatin, Oregon, 97062, United States
Hospital of the University of Pennsylvania, Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104, United States
Tennessee Oncology PLLC
Dickson, Tennessee, 37055, United States
Tennessee Oncology PLLC
Franklin, Tennessee, 37067, United States
Tennessee Oncology PLLC
Gallatin, Tennessee, 37066, United States
Tennessee Oncology PLLC
Hendersonville, Tennessee, 37075, United States
Tennessee Oncology PLLC
Hermitage, Tennessee, 37076, United States
Brig Center for Cancer Care and Survivorship
Knoxville, Tennessee, 37909, United States
Tennessee Oncology PLLC
Lebanon, Tennessee, 37090, United States
Tennessee Oncology PLLC
Murfreesboro, Tennessee, 37129, United States
Tennessee Oncology PLLC
Nashville, Tennessee, 37203, United States
The Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Tennessee Oncology PLLC
Nashville, Tennessee, 37205, United States
Tennessee Oncology PLLC
Nashville, Tennessee, 37207, United States
Tennessee Oncology PLLC
Nashville, Tennessee, 37211, United States
Tennessee Oncology PLLC
Shelbyville, Tennessee, 37160, United States
Tennessee Oncology PLLC
Smyrna, Tennessee, 37167, United States
Texas Oncology - West Texas
Amarillo, Texas, 79124, United States
The Center for Cancer and Blood Disorders
Arlington, Texas, 76014, United States
Texas Oncology - Austin
Austin, Texas, 78731, United States
Texas Oncology - Austin
Austin, Texas, 78745, United States
Texas Oncology - DFWW
Bedford, Texas, 76022, United States
Texas Oncology - DFW
Bedford, Texas, 76022, United States
The Center for Cancer and Blood Disorders
Burleson, Texas, 76028, United States
Texas Oncology - DFW
Dallas, Texas, 75203, United States
Parkland Health and Hospital System
Dallas, Texas, 75235, United States
Texas Oncology - DFWW
Dallas, Texas, 75246, United States
Texas Oncology - DFW
Dallas, Texas, 75246, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
UT Southwestern Medical Center - Simmons Cancer Center Pharmacy
Dallas, Texas, 75390, United States
UT Southwestern Medical Center - Simmons Cancer Center
Dallas, Texas, 75390, United States
UT Southwestern University Hospital - William P. Clements, Jr
Dallas, Texas, 75390, United States
UT Southwestern University Hospital - Zale Lipshy
Dallas, Texas, 75390, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104, United States
UT Southwestern Medical Center - d/b/a Moncrief Cancer Institute - Ft. Worth - Pharmacy
Fort Worth, Texas, 76104, United States
UT Southwestern Medical Center d/b/a Moncrief Cancer Institute - Ft. Worth
Fort Worth, Texas, 76104, United States
Oncology Consultants, P.A.
Houston, Texas, 77024, United States
Texas Oncology - Gulf Coast
Houston, Texas, 77024, United States
Baylor College of Medicine Medical center
Houston, Texas, 77030, United States
Baylor St. Luke's Medical Center
Houston, Texas, 77030, United States
Harris Health System - Ben Taub General Hospital
Houston, Texas, 77030, United States
Oncology Consultants, P.A.
Houston, Texas, 77030, United States
Harris Health System - Smith Clinic
Houston, Texas, 77054, United States
Texas Oncology - San Antonio
New Braunfels, Texas, 78130, United States
UT Southwestern Medical Center - Clinical Center Richardson/Plano - Pharmacy
Richardson, Texas, 75080, United States
UT Southwestern Medical Center - Clinical Center Richardson/Plano
Richardson, Texas, 75080, United States
Texas Oncology-San Antonio
San Antonio, Texas, 78217, United States
Texas Oncology-San Antonio
San Antonio, Texas, 78240, United States
Texas Oncology-San Antonio
San Antonio, Texas, 78258, United States
The Center for Cancer and Blood Disorders
Weatherford, Texas, 76086, United States
University of Utah, Farmington Health Center
Farmington, Utah, 84025, United States
University of Utah, Sugar House Health Center
Salt Lake City, Utah, 84106, United States
University of Utah, Huntsman Cancer Hospital
Salt Lake City, Utah, 84112, United States
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
University of Utah, South Jordan Health Center
South Jordan, Utah, 84009, United States
Virginia Cancer Specialists, PC
Alexandria, Virginia, 22304, United States
Virginia Cancer Specialists, PC
Arlington, Virginia, 22201, United States
Oncology & Hematology Associates of Southwest Virginia,Inc.DBA Blue Ridge Cancer Care
Blacksburg, Virginia, 24060, United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031, United States
Virginia Cancer Specialists, PC
Gainesville, Virginia, 20155, United States
Virginia Cancer Specialists, PC
Leesburg, Virginia, 20176, United States
Oncology and Hematology Associates of Southwest Virginia Inc
Low Moor, Virginia, 24457, United States
Oncology & Hematology Associates of Southwest Virginia,Inc.DBA Blue Ridge Cancer Care
Roanoke, Virginia, 24014, United States
Oncology & Hematology Associates of Southwest Virginia,Inc.DBA Blue Ridge Cancer Care
Salem, Virginia, 24153, United States
Oncology and Hematology Associates of Southwest Virginia Inc
Wytheville, Virginia, 24382, United States
Swedish Cancer Institute - Issaquah Campus
Issaquah, Washington, 98029, United States
Northwest Cancer Specialists P.C.
Vancouver, Washington, 98684, United States
Patricia Ritchie Centre for Cancer Care and Research Mater Hospital Sydney
North Sydney, New South Wales, 2060, Australia
The Crown Princess Mary Cancer Centre, Westmead Hospital
Westmead, New South Wales, 2145, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
The Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Epic Pharmacy Hollywood
Nedlands, Western Australia, 6009, Australia
Hollywood Private Hospital
Nedlands, Western Australia, 6009, Australia
Starcevich Day Clinic, Hollywood Private Hospital
Nedlands, Western Australia, 6009, Australia
Breast Cancer Research Centre - WA
Nedlands, 6009, Australia
Universitatsklinik Innsbruck fur Gynakologie und Geburtshilfe BrustGesundheitzentrum
Innsbruck, 6020, Austria
CT/MRIfacility:Diagnosezentrum Urania
Vienna, 1010, Austria
Klinik Ottakring.
Vienna, 1160, Austria
Wilhelminen Krebsforschung GmbH
Vienna, 1160, Austria
Institut Jules Bordet
Anderlecht, Bruxelles-capitale, Région de, 1070, Belgium
Clinical Trails Conduct Unit(CTCU) Institut Jules Bordet
Brussels, 1000, Belgium
GHdC
Charleroi, 6000, Belgium
University Hospital Antwerp
Edegem, 2650, Belgium
AZ Groeninge
Kortrijk, 8500, Belgium
UZ Leuven
Leuven, 3000, Belgium
CHU de Liege
Liège, 4000, Belgium
CHU UCL Site Sainte Elisabeth
Namur, 5000, Belgium
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
London Regional Cancer Program, London Health Sciences Centre
London, Ontario, N6A 5W9, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Centre Hospitalier de l'Universite de Motreal (CHUM)
Montreal, Quebec, H2X 3E4, Canada
CHU de Québec-Université Laval, St-Sacrement Hospital
Québec, G1S 4L8, Canada
Maternal and child Health Hospital of Guangdong Province
Guangzhou, Guangdong, 511442, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450003, China
Hunan Cancer Hospital.
Changsha, Hu'nan, 410013, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, 430060, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Nanjing Drum Tower Hospital , The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221009, China
Nanchang Third Hospital
Nanchang, Jiangxi, China
Jilin Cancer Hospital
Changchun, Jilin, 130012, China
Shengjing Hospital Of China Medical University
Shenyang, Liaoning, 110004, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061, China
Xi'an International Medical Center Hospital
Xi’an, Shanxi, 710100, China
Zigong First People's Hospital
Zigong, Sichuan, 643000, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060, China
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310002, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
Beijing Hospital
Beijing, 100010, China
Cancer Hospital Chinese Academy of medical sciences
Beijing, 100021, China
Peking University People's Hospital
Beijing, 100044, China
Zhejiang Cancer Hospital
Hangzhou, 310022, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, 530201, China
Tianjin Cancer Hospital
Tianjin, China
Blandecentralen Odense Universitetshospital
Odense C, Other, 5000, Denmark
Onkologisk Afdeling R, Odense Universitetshospital
Odense C, Other, 5000, Denmark
Pharmacy.
Vejle, Other, 7100, Denmark
Herlev og Gentofte Hospital
Herlev, 2730, Denmark
Radiology: Herlev - og Gentofte Hospital - Radiologisk afdeling
Herlev, E2-2730, Denmark
Radiology.
Vejle, 7100, Denmark
Vejle Sygehus
Vejle, 7100, Denmark
University Hospital of Besancon
Besançon, Other, 25030, France
Service de radiologie Centre Francois Baclesse
Caen, Other, 14076 Cedex 5, France
Department de Radiodiagnostic Centre GF Leclerc
Dijon, Other, 21079 Cedex, France
Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes
Lyon, Other, 69008, France
Departement de radiologie Hopital Bretonneau - CHRU de Tours
Tours, Other, 37044 Cedex 9, France
Hopital Bretonneau CHRU de Tours
Tours, Other, 37044 Cedex 9, France
Pharmacie Hopital Bretonneau - CHRU de Tours
Tours, Other, 37044 Cedex 9, France
Departement de radiologie Clinique Victor Hugo
Le Mans, Sarthe, 72000, France
CHRU Besancon Service Radiologie
Besançon, 25000, France
CHRU Besancon
Besançon, 25000, France
Dimeo lmagerie Medicale Polyclinique - Besancon
Besançon, 25000, France
CHRU Morvan Pharmacie des essais cliniques
Brest, 29200, France
CHRU Morvan Unité de recherche clinique en cancérologie
Brest, 29200, France
Centre Francois Baclesse
Caen, 14076, France
Centre GF Leclerc
Dijon, 21079, France
Clinique du mail
Grenoble, 38100, France
Clinique Victor Hugo Centre de Cancerologie de la Sarthe
Le Mans, 72000, France
Centre Leon Berard Departement de Medecine
Lyon, 69008, France
Departement de radiologie Centre Leon Berard
Lyon, 69373 CEDEX 08, France
Pharmacie des essais cliniques -lnstitut Paoli calmettes
Marseille, 13009, France
lnstitut Paoli Calmettes, Departement ONCOLOGIE MEDICALE
Marseille, 13273, France
Groupement hospitalier Portes de Provence Quartier Beausseret
Montélimar, 26216 cedex, France
Departement d'imagerie medicale Institut Curie - Site Paris
Paris, 75248 Cedex 05, France
lnstitut Curie- Site Paris
Paris, 75248, France
Centre Paul Strauss - pharmacie
Strasbourg, 67065, France
lnstitut de cancerologie Strasbourg Europe
Strasbourg, 67200, France
IUCT-O
Toulouse, 31059 Cedex 9, France
lnstitut Claudius Regaud - IUCT-O
Toulouse, 31059, France
Hopital Nord Franche-Comte Pole imagerie radiologie
Trévenans, 90400, France
Universitatsmedizin Mainz
Mainz, Other, 55131, Germany
Universitätsklinikum Schleswig-Holstein - Campus Kiel
Kiel, Schleswig-Holstein, 24105, Germany
InVO-lnstitut für Versorgungsforschung in der Onkologie GbR
Koblenz, 56068, Germany
Klinikum rechts der Isar, Klinik und Poliklinik fur Frauenheikunde
München, 81675, Germany
Sana Klinikum Offenbach GmbH Zentralinstitut fur Diagnostische und Interventionelle Radiologie
Offenbach/ Main, 63069, Germany
Oncology Institute, Meir Medical Center
Kfar Saba, 4428164, Israel
Institute of Oncology - Davidoff Center, Rabin Medical Center, Beilinson Hospital
Petah Tikva, 4941492, Israel
Oncology Institute, Kaplan Medical Center
Rehovot, 7610001, Israel
A.O.U. Ospedali Riuniti di Ancona.
Torrette, Ancona, 60126, Italy
Azienda Ospedaliero Universitaria di Bologna - IRCCS
Bologna, Emilia-Romagna, 40138, Italy
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
Bologna, Emilia-Romagna, 40138, Italy
Fondazione Policlinico Gemelli IRCCS
Rome, Lazio, 00168, Italy
AUSL della Romagna. P.O. Ospedale degli lnfermi. U.O. di Oncologia.
Faenza, Ravenna, 48018, Italy
AUSL della Romagna. P.O. Ospedale di Lugo Umberto I. U.O. di Oncologia.
Lugo, Ravenna, 48022, Italy
AUSL della Romagna. P.O. Ospedale Cervesi. U.O. di Oncologia.
Cattolica, Rimini, 47841, Italy
lstituto Europeo di Oncologia
Milan, 20141, Italy
AUSL della Romagna. P.O. Ospedale Santa Maria delle Croci. U.O. di Oncologia.
Ravenna, 48121, Italy
AUSL della Romagna P.O. Ospedale Infermi U.O. di Oncologia
Rimini, 47923, Italy
Nagoya Radiological Diagnosis Foundation, East Nagoya Imaging Diagnosis Center
Nagoya, Aichi-ken, 464-0044, Japan
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 464-8681, Japan
National Cancer Center Hospital East.
Kashiwa, Chiba, 277-8577, Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Chūgoku, 730-8518, Japan
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, 791-0280, Japan
National Hospital Organization Kyushu Cancer Center.
Fukuoka, Fukuoka, 811-1395, Japan
National Hospital Organization Hokkaido Cancer Center.
Sapporo, Hokkaido, 003-0804, Japan
Hyogo college of medicine hospital
Nishinomiya, Hyōgo, 663-8501, Japan
University of Tsukuba Hospital
Tsukuba, Ibaraki, 305-8576, Japan
Hakuaikai Medical Corporation Sagara Hospital
Kagoshima, Kagoshima-ken, 892-0833, Japan
Hakuaikai Medical Corporation Sagara Perth Street Clinic
Kagoshima, Kagoshima-ken, 892-0838, Japan
Koyasu Neurosurgical Clinic
Yokohama, Kanagawa, 241-0821, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515, Japan
Morinomiya Hospital
Osaka, Osaka, 536-0025, Japan
Saitama Cancer Center, Breast Oncology
Kitaadachi-gun, Saitama, 362-0806, Japan
Shizuoka Cancer Center
Nagaizumi-cho, Shizuoka, 411-8777, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045, Japan
Chiba Cancer Center
Chiba, 260-8717, Japan
Advanced Imaging Center
Ibaraki, 305-8576, Japan
Kumamoto Shinto General Hospital
Kumamoto, 862-8655, Japan
National Hospital Organization Osaka National Hospital
Osaka, 540-0006, Japan
Osaka Prefectural Hospital Organization Osaka International Cancer Institute
Osaka, 541-8567, Japan
The Cancer Institute Hospital of JFCR
Tokyo, 135-8550, Japan
Amphia Ziekenhuis
Breda, 4818 CK, Netherlands
Martini Ziekenhuis
Groningen, 9728 TN, Netherlands
Erasmus Medisch Centrum Daniel Den Hoed
Rotterdam, 3015 GD, Netherlands
National Cancer Centre Singapore
Singapore, Other, 168583, Singapore
National University Hospital
Singapore, 119074, Singapore
National Cancer Center
Goyang-si, Gyeonggi-do, 10408, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
National Cancer Center
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07120, Spain
Hospital Quiron Barcelona
Barcelona, Other, 08023, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa CRUZ DE Tenerife, 38320, Spain
Vall d'Hebron University Hospital
Barcelona, 08035, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Clinica Nuestra Senora del Rosario
Madrid, 28006, Spain
Hospital Ruber Internacional
Madrid, 28034, Spain
Hospital Universitario Clinico San Carlos
Madrid, 28040, Spain
Hospital Universitario HM Sanchinarro
Madrid, 28050, Spain
Hospital Moises Broggi- ICO
Sant Joan Despí, 08970, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Hospital Quirón Zaragoza
Zaragoza, 50006, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
Sahlgrenska University Hospital
Gothenburg, 413 45, Sweden
Onkologkliniken, KPE, Malpunkt K,
J0nkoping, SE-551 85, Sweden
Centre Hospitalier Universitaire Vaudois
Lausanne, 1011, Switzerland
Kantonsspital Winterthur Onkologie
Winterthur, 8401, Switzerland
National Cheng Kung University Hospital
Tainan, 704, R.O.C., Taiwan
National Taiwan University Hospital
Taipei, 100225, Taiwan
The Royal Cornwall Hospital
Truro, Cornwall, TR1 3LJ, United Kingdom
"Edinburgh Cancer Centre, Western General Hospital,"
Edinburgh, Scotland, EH4 2XU, United Kingdom
University Hospitals Birmingham NHS Foundation Trust Queen Elizabeth Hospital
Birmingham, B15 2TH, United Kingdom
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT, United Kingdom
Related Publications (1)
Hurvitz SA, Loi S, O'Shaughnessy J, Okines AFC, Tolaney SM, Sohn J, Saura C, Zhu X, Cameron D, Bachelot T, Hamilton E, Curigliano G, Wolff AC, Harbeck N, Masuda N, Vahdat L, Zaman K, Valdes-Albini F, Block M, Pluard T, Tan TJ, Gawryletz C, Chan A, Bedard PL, Yerushalmi R, Xu B, Schmitt M, Xie D, Borges VF; HER2CLIMB-02 study investigators. Tucatinib and trastuzumab emtansine for patients with previously treated HER2-positive locally advanced and metastatic breast cancer: primary analysis of the randomized phase III trial HER2CLIMB-02. Ann Oncol. 2026 Mar;37(3):341-352. doi: 10.1016/j.annonc.2025.11.005. Epub 2025 Nov 17.
PMID: 41260264DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Seagen Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2019
First Posted
June 5, 2019
Study Start
October 2, 2019
Primary Completion
June 29, 2023
Study Completion (Estimated)
March 10, 2029
Last Updated
March 30, 2026
Results First Posted
July 30, 2024
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.