A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer

March 16, 2026 updated by: Seagen, a wholly owned subsidiary of Pfizer

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

HER2-positive Breast Cancer

Intervention / Treatment

Detailed Description

This study is designed to evaluate the efficacy and safety of tucatinib in combination with T-DM1 in participants with unresectable locally-advanced or metastatic HER2+ breast cancer who have had prior treatment with a taxane and trastuzumab in any setting. Prior pertuzumab treatment is permitted, but not required. Participants will be randomized in a 1:1 manner to receive 21-day cycles of either tucatinib or placebo in combination with T-DM1.

While on study treatment, participants will be assessed for progression every 6 weeks for the first 24 weeks, and every 9 weeks thereafter, irrespective of dose holds or interruptions. Study treatment will continue until unacceptable toxicity, disease progression, withdrawal of consent, or study closure. After completion of study treatment and after occurrence of disease progression, participants in both arms of the study will continue to be followed for survival until study closure or withdrawal of consent.

Study Type

Interventional

Enrollment (Actual)

466

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- - Nedlands, Australia, 6009
    - Breast Cancer Research Centre - WA
- New South Wales
  - North Sydney, New South Wales, Australia, 2060
    - Patricia Ritchie Centre for Cancer Care and Research Mater Hospital Sydney
  - Westmead, New South Wales, Australia, 2145
    - The Crown Princess Mary Cancer Centre, Westmead Hospital
- Victoria
  - Heidelberg, Victoria, Australia, 3084
    - Austin Health
  - Melbourne, Victoria, Australia, 3000
    - Peter MacCallum Cancer Centre
  - Parkville, Victoria, Australia, 3050
    - The Royal Melbourne Hospital
- Western Australia
  - Nedlands, Western Australia, Australia, 6009
    - Hollywood Private Hospital
  - Nedlands, Western Australia, Australia, 6009
    - Epic Pharmacy Hollywood
  - Nedlands, Western Australia, Australia, 6009
    - Starcevich Day Clinic, Hollywood Private Hospital
Austria
- - Innsbruck, Austria, 6020
    - Universitatsklinik Innsbruck fur Gynakologie und Geburtshilfe BrustGesundheitzentrum
  - Vienna, Austria, 1010
    - CT/MRIfacility:Diagnosezentrum Urania
  - Vienna, Austria, 1160
    - Klinik Ottakring.
  - Vienna, Austria, 1160
    - Wilhelminen Krebsforschung GmbH
Belgium
- - Brussels, Belgium, 1000
    - Clinical Trails Conduct Unit(CTCU) Institut Jules Bordet
  - Charleroi, Belgium, 6000
    - GHdC
  - Edegem, Belgium, 2650
    - University Hospital Antwerp
  - Kortrijk, Belgium, 8500
    - Az Groeninge
  - Leuven, Belgium, 3000
    - UZ Leuven
  - Liège, Belgium, 4000
    - CHU de Liege
  - Namur, Belgium, 5000
    - CHU UCL Site Sainte Elisabeth
- Bruxelles-capitale, Région de
  - Anderlecht, Bruxelles-capitale, Région de, Belgium, 1070
    - Institut Jules Bordet
Canada
- - Québec, Canada, G1S 4L8
    - CHU de Québec-Université Laval, St-Sacrement Hospital
- Alberta
  - Edmonton, Alberta, Canada, T6G 1Z2
    - Cross Cancer Institute
- Ontario
  - London, Ontario, Canada, N6A 5W9
    - London Regional Cancer Program, London Health Sciences Centre
  - Ottawa, Ontario, Canada, K1H 8L6
    - The Ottawa Hospital Cancer Centre
  - Toronto, Ontario, Canada, M5G 2M9
    - Princess Margaret Cancer Centre
- Quebec
  - Montreal, Quebec, Canada, H2X 3E4
    - Centre Hospitalier de l'Universite de Motreal (CHUM)
China
- - Beijing, China, 100044
    - Peking University People's Hospital
  - Beijing, China, 100021
    - Cancer Hospital Chinese Academy of Medical Sciences
  - Beijing, China, 100010
    - Beijing Hospital
  - Hangzhou, China, 310022
    - Zhejiang Cancer Hospital
  - Nanning, China, 530201
    - Guangxi Medical University Affiliated Tumor Hospital
  - Tianjin, China
    - Tianjin cancer hospital
- Guangdong
  - Guangzhou, Guangdong, China
    - Sun Yat-sen University Cancer Center
  - Guangzhou, Guangdong, China, 511442
    - Maternal and child Health Hospital of Guangdong Province
  - Zhanjiang, Guangdong, China, 524000
    - Affiliated Hospital Of Guangdong Medical University
- Henan
  - Zhengzhou, Henan, China, 450003
    - Henan Cancer Hospital
- Hu'nan
  - Changsha, Hu'nan, China, 410013
    - Hunan Cancer Hospital.
- Hubei
  - Wuhan, Hubei, China, 430079
    - Hubei Cancer Hospital
  - Wuhan, Hubei, China, 430060
    - Renmin Hospital of Wuhan University
- Jiangsu
  - Nanjing, Jiangsu, China, 210008
    - Nanjing Drum Tower Hospital ， The Affiliated Hospital of Nanjing University Medical School
  - Xuzhou, Jiangsu, China, 221009
    - Xuzhou Central Hospital
- Jiangxi
  - Nanchang, Jiangxi, China
    - Nanchang Third Hospital
- Jilin
  - Changchun, Jilin, China, 130012
    - Jilin Cancer Hospital
- Liaoning
  - Shenyang, Liaoning, China, 110004
    - Shengjing Hospital Of China Medical University
- Shanxi
  - Xi’an, Shanxi, China, 710061
    - The First Affiliated Hospital of Xi'an Jiaotong University
  - Xi’an, Shanxi, China, 710100
    - Xi'an International Medical Center Hospital
- Sichuan
  - Zigong, Sichuan, China, 643000
    - Zigong First People's Hospital
- Tianjin Municipality
  - Tianjin, Tianjin Municipality, China, 300060
    - Tianjin cancer hospital
- Zhejiang
  - Hangzhou, Zhejiang, China, 310009
    - The Second Affiliated Hospital Zhejiang University School of Medicine
  - Hangzhou, Zhejiang, China, 310002
    - The First Affiliated Hospital Zhejiang University School of Medicine
Denmark
- - Herlev, Denmark, 2730
    - Herlev og Gentofte Hospital
  - Herlev, Denmark, E2-2730
    - Radiology: Herlev - og Gentofte Hospital - Radiologisk afdeling
  - Vejle, Denmark, 7100
    - Vejle Sygehus
  - Vejle, Denmark, 7100
    - Radiology.
- Other
  - Odense C, Other, Denmark, 5000
    - Blandecentralen Odense Universitetshospital
  - Odense C, Other, Denmark, 5000
    - Onkologisk Afdeling R, Odense Universitetshospital
  - Vejle, Other, Denmark, 7100
    - Pharmacy.
France
- - Besançon, France, 25000
    - CHRU Besançon
  - Besançon, France, 25000
    - CHRU Besancon Service Radiologie
  - Besançon, France, 25000
    - Dimeo lmagerie Medicale Polyclinique - Besancon
  - Brest, France, 29200
    - CHRU Morvan Pharmacie des essais cliniques
  - Brest, France, 29200
    - CHRU Morvan Unité de recherche clinique en cancérologie
  - Caen, France, 14076
    - Centre François Baclesse
  - Dijon, France, 21079
    - Centre GF Leclerc
  - Grenoble, France, 38100
    - Clinique du Mail
  - Le Mans, France, 72000
    - Clinique Victor Hugo Centre de Cancerologie de la Sarthe
  - Lyon, France, 69008
    - Centre Leon Berard Departement de Medecine
  - Lyon, France, 69373 CEDEX 08
    - Departement de radiologie Centre Leon Berard
  - Marseille, France, 13009
    - Pharmacie des essais cliniques -lnstitut Paoli calmettes
  - Marseille, France, 13273
    - lnstitut Paoli Calmettes, Departement ONCOLOGIE MEDICALE
  - Montélimar, France, 26216 cedex
    - Groupement hospitalier Portes de Provence Quartier Beausseret
  - Paris, France, 75248 Cedex 05
    - Departement d'imagerie medicale Institut Curie - Site Paris
  - Paris, France, 75248
    - lnstitut Curie- Site Paris
  - Strasbourg, France, 67065
    - Centre Paul Strauss - pharmacie
  - Strasbourg, France, 67200
    - lnstitut de cancerologie Strasbourg Europe
  - Toulouse, France, 31059 Cedex 9
    - IUCT-O
  - Toulouse, France, 31059
    - lnstitut Claudius Regaud - IUCT-O
  - Trévenans, France, 90400
    - Hopital Nord Franche-Comte Pole imagerie radiologie
- Other
  - Besançon, Other, France, 25030
    - University Hospital of Besancon
  - Caen, Other, France, 14076 Cedex 5
    - Service de radiologie Centre Francois Baclesse
  - Dijon, Other, France, 21079 Cedex
    - Department de Radiodiagnostic Centre GF Leclerc
  - Lyon, Other, France, 69008
    - Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes
  - Tours, Other, France, 37044 Cedex 9
    - Departement de radiologie Hopital Bretonneau - CHRU de Tours
  - Tours, Other, France, 37044 Cedex 9
    - Hopital Bretonneau CHRU de Tours
  - Tours, Other, France, 37044 Cedex 9
    - Pharmacie Hopital Bretonneau - CHRU de Tours
- Sarthe
  - Le Mans, Sarthe, France, 72000
    - Departement de radiologie Clinique Victor Hugo
Germany
- - Koblenz, Germany, 56068
    - InVO-lnstitut für Versorgungsforschung in der Onkologie GbR
  - München, Germany, 81675
    - Klinikum rechts der Isar, Klinik und Poliklinik fur Frauenheikunde
  - Offenbach/ Main, Germany, 63069
    - Sana Klinikum Offenbach GmbH Zentralinstitut fur Diagnostische und Interventionelle Radiologie
- Other
  - Mainz, Other, Germany, 55131
    - Universitätsmedizin Mainz
- Schleswig-Holstein
  - Kiel, Schleswig-Holstein, Germany, 24105
    - Universitätsklinikum Schleswig-Holstein - Campus Kiel
Israel
- - Kfar Saba, Israel, 4428164
    - Oncology Institute, Meir Medical Center
  - Petah Tikva, Israel, 4941492
    - Institute of Oncology - Davidoff Center, Rabin Medical Center, Beilinson Hospital
  - Rehovot, Israel, 7610001
    - Oncology Institute, Kaplan Medical Center
Italy
- - Milan, Italy, 20141
    - lstituto Europeo di Oncologia
  - Ravenna, Italy, 48121
    - AUSL della Romagna. P.O. Ospedale Santa Maria delle Croci. U.O. di Oncologia.
  - Rimini, Italy, 47923
    - AUSL della Romagna P.O. Ospedale Infermi U.O. di Oncologia
- Ancona
  - Torrette, Ancona, Italy, 60126
    - A.O.U. Ospedali Riuniti di Ancona.
- Emilia-Romagna
  - Bologna, Emilia-Romagna, Italy, 40138
    - Azienda Ospedaliero Universitaria di Bologna - IRCCS
  - Bologna, Emilia-Romagna, Italy, 40138
    - Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
- Lazio
  - Rome, Lazio, Italy, 00168
    - Fondazione Policlinico Gemelli IRCCS
- Ravenna
  - Faenza, Ravenna, Italy, 48018
    - AUSL della Romagna. P.O. Ospedale degli lnfermi. U.O. di Oncologia.
  - Lugo, Ravenna, Italy, 48022
    - AUSL della Romagna. P.O. Ospedale di Lugo Umberto I. U.O. di Oncologia.
- Rimini
  - Cattolica, Rimini, Italy, 47841
    - AUSL della Romagna. P.O. Ospedale Cervesi. U.O. di Oncologia.
Japan
- - Chiba, Japan, 260-8717
    - Chiba Cancer Center
  - Ibaraki, Japan, 305-8576
    - Advanced Imaging Center
  - Kumamoto, Japan, 862-8655
    - Kumamoto Shinto General Hospital
  - Osaka, Japan, 540-0006
    - National Hospital Organization Osaka National Hospital
  - Osaka, Japan, 541-8567
    - Osaka Prefectural Hospital Organization Osaka International Cancer Institute
  - Tokyo, Japan, 135-8550
    - The Cancer Institute Hospital of JFCR
- Aichi-ken
  - Nagoya, Aichi-ken, Japan, 464-8681
    - Aichi Cancer Center Hospital
  - Nagoya, Aichi-ken, Japan, 464-0044
    - Nagoya Radiological Diagnosis Foundation, East Nagoya Imaging Diagnosis Center
- Chiba
  - Kashiwa, Chiba, Japan, 277-8577
    - National Cancer Center Hospital East.
- Chūgoku
  - Hiroshima, Chūgoku, Japan, 730-8518
    - Hiroshima City Hiroshima Citizens Hospital
- Ehime
  - Matsuyama, Ehime, Japan, 791-0280
    - National Hospital Organization Shikoku Cancer Center
- Fukuoka
  - Fukuoka, Fukuoka, Japan, 811-1395
    - National Hospital Organization Kyushu Cancer Center.
- Hokkaido
  - Sapporo, Hokkaido, Japan, 003-0804
    - National Hospital Organization Hokkaido Cancer Center.
- Hyōgo
  - Nishinomiya, Hyōgo, Japan, 663-8501
    - Hyogo College of Medicine Hospital
- Ibaraki
  - Tsukuba, Ibaraki, Japan, 305-8576
    - University of Tsukuba Hospital
- Kagoshima-ken
  - Kagoshima, Kagoshima-ken, Japan, 892-0833
    - Hakuaikai Medical Corporation Sagara Hospital
  - Kagoshima, Kagoshima-ken, Japan, 892-0838
    - Hakuaikai Medical Corporation Sagara Perth Street Clinic
- Kanagawa
  - Yokohama, Kanagawa, Japan, 241-8515
    - Kanagawa Cancer Center
  - Yokohama, Kanagawa, Japan, 241-0821
    - Koyasu Neurosurgical Clinic
- Osaka
  - Osaka, Osaka, Japan, 536-0025
    - Morinomiya Hospital
- Saitama
  - Kitaadachi-gun, Saitama, Japan, 362-0806
    - Saitama Cancer Center, Breast Oncology
- Shizuoka
  - Nagaizumi-cho, Shizuoka, Japan, 411-8777
    - Shizuoka Cancer Center
- Tokyo
  - Chuo-ku, Tokyo, Japan, 104-0045
    - National Cancer Center Hospital
Netherlands
- - Breda, Netherlands, 4818 CK
    - Amphia Ziekenhuis
  - Groningen, Netherlands, 9728 TN
    - Martini Ziekenhuis
  - Rotterdam, Netherlands, 3015 GD
    - Erasmus Medisch Centrum Daniel Den Hoed
Singapore
- - Singapore, Singapore, 119074
    - National University Hospital
- Other
  - Singapore, Other, Singapore, 168583
    - National Cancer Centre Singapore
South Korea
- - Seoul, South Korea, 03080
    - Seoul National University Hospital
  - Seoul, South Korea, 05505
    - Asan Medical Center
  - Seoul, South Korea, 03722
    - Severance Hospital Yonsei University Health System
  - Seoul, South Korea, 06351
    - Samsung Medical Center
  - Seoul, South Korea, 02841
    - National Cancer Center
- Gyeonggi-do
  - Goyang-si, Gyeonggi-do, South Korea, 10408
    - National Cancer Center
  - Seongnam-si, Gyeonggi-do, South Korea, 13620
    - Seoul National University Bundang Hospital
Spain
- - Barcelona, Spain, 08035
    - Vall d'Hebron University Hospital
  - Córdoba, Spain, 14004
    - Hospital Universitario Reina Sofia
  - Madrid, Spain, 28006
    - Clinica Nuestra Senora del Rosario
  - Madrid, Spain, 28040
    - Hospital Universitario Clínico San Carlos
  - Madrid, Spain, 28034
    - Hospital Ruber Internacional
  - Madrid, Spain, 28050
    - Hospital Universitario HM Sanchinarro
  - Sant Joan Despí, Spain, 08970
    - Hospital Moises Broggi- ICO
  - Seville, Spain, 41013
    - Hospital Universitario Virgen del Rocio
  - Valencia, Spain, 46010
    - Hospital Clinico Universitario de Valencia
  - Zaragoza, Spain, 50009
    - Hospital Universitario Miguel Servet
  - Zaragoza, Spain, 50006
    - Hospital Quirón Zaragoza
- Balearic Islands
  - Palma de Mallorca, Balearic Islands, Spain, 07120
    - Hospital Universitario Son Espases
- Other
  - Barcelona, Other, Spain, 08023
    - Hospital Quiron Barcelona
- Santa CRUZ DE Tenerife
  - San Cristóbal de La Laguna, Santa CRUZ DE Tenerife, Spain, 38320
    - Hospital Universitario de Canarias
Sweden
- - Gothenburg, Sweden, 413 45
    - Sahlgrenska University Hospital
  - J0nkoping, Sweden, SE-551 85
    - Onkologkliniken, KPE, Malpunkt K,
Switzerland
- - Lausanne, Switzerland, 1011
    - Centre Hospitalier Universitaire Vaudois
  - Winterthur, Switzerland, 8401
    - Kantonsspital Winterthur Onkologie
Taiwan
- - Tainan, Taiwan, 704, R.O.C.
    - National Cheng Kung University Hospital
  - Taipei, Taiwan, 100225
    - National Taiwan University Hospital
United Kingdom
- - Birmingham, United Kingdom, B15 2TH
    - University Hospitals Birmingham NHS Foundation Trust Queen Elizabeth Hospital
  - London, United Kingdom, SW3 6JJ
    - The Royal Marsden NHS Foundation Trust
  - Manchester, United Kingdom, M20 4BX
    - The Christie NHS Foundation Trust
  - Sutton, United Kingdom, SM2 5PT
    - The Royal Marsden NHS Foundation Trust
- Cornwall
  - Truro, Cornwall, United Kingdom, TR1 3LJ
    - The Royal Cornwall Hospital
- Scotland
  - Edinburgh, Scotland, United Kingdom, EH4 2XU
    - "Edinburgh Cancer Centre, Western General Hospital,"
United States
- Alabama
  - Mobile, Alabama, United States, 36604
    - University of South Alabama Mitchell Cancer Institute
  - Mobile, Alabama, United States, 36604
    - University of South Alabama Health Children's and Women's Hospital
  - Mobile, Alabama, United States, 36617
    - University of South Alabama Health University Hospital
- Arizona
  - Gilbert, Arizona, United States, 85234
    - Banner MD Anderson Cancer Center
  - Gilbert, Arizona, United States, 85234
    - Banner Gateway Medical Center
  - Goodyear, Arizona, United States, 85338
    - Western Regional Medical Center, LLC
  - Tucson, Arizona, United States, 85711
    - Arizona Oncology Associates, PC - HOPE
  - Tucson, Arizona, United States, 85704
    - Arizona Oncology Associates, PC - HOPE
  - Tucson, Arizona, United States, 85704
    - Arizona Oncology Associates, PC - HOPE.
- California
  - Alhambra, California, United States, 91801
    - UCLA Hematology/Oncology - Alhambra
  - Antioch, California, United States, 94509
    - Kaiser Permanente Medical Center Lab Drawing Station
  - Antioch, California, United States, 94531
    - Kaiser Permanente Medical Center Lab Drawing Station
  - Beverly Hills, California, United States, 90212
    - UCLA Hematology/Oncology- Beverly Hills
  - Costa Mesa, California, United States, 92627
    - UC Irvine Health Cancer Center - Newport
  - Duarte, California, United States, 91010
    - City of Hope Investigational Drug Services (IDS)
  - Duarte, California, United States, 91010
    - City of Hope(City of Hope National Medical Center,City of Hope Medical Center)
  - Dublin, California, United States, 94568
    - Kaiser Permanente Medical Center (Radiology)
  - Encino, California, United States, 91436
    - UCLA Hematology/Oncology - Encino
  - Fairfield, California, United States, 94533
    - Kaiser Permanente Medical Center Lab Drawing Station
  - Gilroy, California, United States, 95020
    - Kaiser Permanente Medical Center Lab Drawing Station
  - Irvine, California, United States, 92604
    - UCLA Hematology/Oncology- Irvine
  - Los Angeles, California, United States, 90095
    - Ronald Reagan UCLA Medical Center
  - Los Angeles, California, United States, 90095
    - UCLA Hematology/Oncology
  - Los Angeles, California, United States, 90095
    - Regulatory Management Only: TRIO-US Central Administration
  - Los Angeles, California, United States, 90095
    - Drug Management Only: UCLA West Medical Pharmacy, Attn: Steven L Wong, Pharm.D.
  - Los Angeles, California, United States, 90095
    - UCLA West Medical Pharmacy
  - Martinez, California, United States, 94553
    - Kaiser Permanente Medical Center Lab Drawing Station
  - Milpitas, California, United States, 95035
    - Kaiser Permanente Medical Center Lab Drawing Station
  - Modesto, California, United States, 95356
    - Kaiser Permanente Medical Center Lab Drawing Station
  - Mountain View, California, United States, 94041
    - Kaiser Permanente Medical Center Lab Drawing Station
  - Napa, California, United States, 94558
    - Kaiser Permanente Medical Center Lab Drawing Station
  - Oakland, California, United States, 94611
    - Kaiser Permanente Medical Center (clinic+DSL)
  - Oakland, California, United States, 94611
    - Kaiser Permanente Medical Center (Radiology)
  - Orange, California, United States, 92868
    - Chao Family Comprehensive Cancer Center University of California Irvine
  - Orange, California, United States, 92868
    - UC Irvine Medical Center Attn: Trisha Maris
  - Orange, California, United States, 92868
    - UCI Medical Center - Chao Family Comprehensive Cancer Center
  - Pleasanton, California, United States, 94588
    - Kaiser Permanente Medical Center Lab Drawing Station
  - Porter Ranch, California, United States, 91326
    - UCLA Hematology/Oncology - Porter Ranch
  - Redwood City, California, United States, 94063
    - Kaiser Permanente Medical Center Lab Drawing Station
  - Roseville, California, United States, 95661
    - Kaiser Permanente Medical Center (clinic+DSL)
  - Sacramento, California, United States, 95817
    - University of California Davis
  - Sacramento, California, United States, 95817
    - University of California Davis Medical Center
  - Sacramento, California, United States, 95814
    - Kaiser Permanente Sacramento J Street Medical Center (clinic+DSL+Lab Drawing Station)
  - Sacramento, California, United States, 95825
    - Kaiser Permanente Medical Center (Radiology)
  - San Francisco, California, United States, 94110
    - Zuckerberg San Francisco General Hospital
  - San Francisco, California, United States, 94518
    - Kaiser Permanente Mission Bay Medical Center Lab Drawing Station
  - San Francisco, California, United States, 94115
    - Kaiser Permanente Medical Center (clinic+DSL)
  - San Francisco, California, United States, 94158
    - University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center.
  - San Jose, California, United States, 95110
    - Kaiser Permanente Medical Center Lab Drawing Station
  - San Jose, California, United States, 95119
    - Kaiser Permanente Medical Center (clinic+DSL)
  - San Leandro, California, United States, 94577
    - Kaiser Permanente Medical Center (clinic+DSL)
  - San Luis Obispo, California, United States, 93401
    - UCLA Hematology/Oncology - San Luis Obispo
  - Santa Clara, California, United States, 95051
    - Kaiser Permanente Medical Center (clinic+DSL)
  - Santa Monica, California, United States, 90404
    - UCLA Hematology/Oncology - Santa Monica
  - Santa Monica, California, United States, 90404
    - UCLA Hematology/Oncology Parkside
  - South San Francisco, California, United States, 94080
    - Kaiser Permanente Medical Center (clinic+DSL)
  - Torrance, California, United States, 90505
    - Torrance Memorial Physician Network - Cancer Care
  - Torrance, California, United States, 90505
    - Torrance Memorial Physician Network-Cancer Care
  - Torrance, California, United States, 90505
    - UCLA Torrance Oncology
  - Valencia, California, United States, 91355
    - UCLA Hematology/Oncology - Santa Clarita
  - Vallejo, California, United States, 94589
    - Kaiser Permanente Medical Center (clinic+DSL)
  - Ventura, California, United States, 93003
    - UCLA Hematology/Oncology - Ventura
  - Walnut Creek, California, United States, 94596
    - Kaiser Permanente Medical Center (clinic+DSL)
- Colorado
  - Aurora, Colorado, United States, 80045
    - University of Colorado Hospital
  - Aurora, Colorado, United States, 80045
    - University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
  - Aurora, Colorado, United States, 80045
    - University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
  - Aurora, Colorado, United States, 80012
    - Rocky Mountain Cancer Centers, LLP
  - Aurora, Colorado, United States, 80045
    - Clinical and Translational Research Center (CTRC)
  - Aurora, Colorado, United States, 80045
    - University of Colorado Hospital - Anschutz Cancer Pavilion(ACP)
  - Boulder, Colorado, United States, 80303
    - Rocky Mountain Cancer Centers, LLP
  - Centennial, Colorado, United States, 80112
    - Rocky Mountain Cancer Centers, LLP
  - Colorado Springs, Colorado, United States, 80907
    - Rocky Mountain Cancer Centers, LLP
  - Colorado Springs, Colorado, United States, 80909
    - UCH-MHS Memorial Hospital Central
  - Colorado Springs, Colorado, United States, 80910
    - Printers Park Medical Plaza
  - Colorado Springs, Colorado, United States, 80920
    - Briargate Medical Campus
  - Colorado Springs, Colorado, United States, 80920
    - UCH-MHS Memorial Hospital North
  - Denver, Colorado, United States, 80218
    - SCL Health Saint Joseph Hospital
  - Denver, Colorado, United States, 80218
    - Rocky Mountain Cancer Centers, LLP
  - Denver, Colorado, United States, 80220
    - Rocky Mountain Cancer Centers, LLP
  - Denver, Colorado, United States, 80206
    - UCHealth Cherry Creek Medical Center
  - Denver, Colorado, United States, 80206
    - UCHealth IDS Research Pharmacy - Cherry Creek
  - Denver, Colorado, United States, 80218
    - Cancer Centers of Colorado at Saint Joseph Hospital
  - Fort Collins, Colorado, United States, 80524
    - Poudre Valley Hospital
  - Fort Collins, Colorado, United States, 80528
    - Cancer Care & Hematology - Fort Collins
  - Greeley, Colorado, United States, 80634
    - Cancer Care & Hematology - Greeley
  - Lafayette, Colorado, United States, 80026
    - SCL Health Good Samaritan Medical Center Cancer Centers of Colorado
  - Lafayette, Colorado, United States, 80026
    - SCL Health Good Samaritan Medical Center
  - Lakewood, Colorado, United States, 80228
    - Rocky Mountain Cancer Centers, LLP
  - Littleton, Colorado, United States, 80120
    - Rocky Mountain Cancer Centers, LLP
  - Lone Tree, Colorado, United States, 80124
    - Rocky Mountain Cancer Centre, LLP
  - Loveland, Colorado, United States, 80538
    - Cancer Care & Hematology - Loveland
  - Thornton, Colorado, United States, 80260
    - Rocky Mountain Cancer Centers, LLP
- District of Columbia
  - Washington D.C., District of Columbia, United States, 20007
    - Georgetown University Medical Center
  - Washington D.C., District of Columbia, United States, 20010
    - Washington Cancer Institute at MedStar Washington Hospital Center
- Florida
  - Altamonte Springs, Florida, United States, 32701
    - Florida Cancer Specialists
  - Bonita Springs, Florida, United States, 34135
    - Florida Cancer Specialists
  - Brandon, Florida, United States, 33511
    - Florida Cancer Specialists
  - Cape Coral, Florida, United States, 33909
    - Florida Cancer Specialists
  - Clearwater, Florida, United States, 33761
    - Florida Cancer Specialists
  - Coral Gables, Florida, United States, 33146
    - Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center
  - Daytona Beach, Florida, United States, 32117
    - Florida Cancer Specialists.
  - Deerfield Beach, Florida, United States, 33442
    - Sylvester Comprehensive Cancer Center- Deerfield Beach
  - Fort Myers, Florida, United States, 33905
    - Florida Cancer Specialists
  - Fort Myers, Florida, United States, 33908
    - Florida Cancer Specialists
  - Fort Myers, Florida, United States, 33901
    - Florida Cancer Specialists - South Region
  - Gainesville, Florida, United States, 32605
    - Florida Cancer Specialists
  - Jacksonville, Florida, United States, 32207
    - Baptist MD Anderson Cancer Center
  - Largo, Florida, United States, 33770
    - Florida Cancer Specialists
  - Lecanto, Florida, United States, 34461
    - Florida Cancer Specialists
  - Miami, Florida, United States, 33176
    - Miami Cancer Institute at Baptist Health, Inc.
  - Miami, Florida, United States, 33136
    - Sylvester Comprehensive Cancer Center
  - Miami, Florida, United States, 33136
    - Bascom Palmer Eye Institute
  - Miami, Florida, United States, 33176
    - Sylvester Comprehensive Cancer Center Kendall
  - Naples, Florida, United States, 34102
    - Florida Cancer Specialists
  - Ocala, Florida, United States, 34474
    - Florida Cancer Specialists
  - Orlando, Florida, United States, 32803
    - AdventHealth Orlando
  - Orlando, Florida, United States, 32806
    - Florida Cancer Specialists
  - Orlando, Florida, United States, 32804
    - AdventHealth Hematology and Oncology
  - Orlando, Florida, United States, 32804
    - AdventHealth Orlando Infusion Center
  - Orlando, Florida, United States, 32806
    - Orlando Health, Inc. TRIO
  - Orlando, Florida, United States, 32804
    - AdventHealth Orlando, Investigational Drug Services
  - Orlando, Florida, United States, 32804
    - AdventHealth Medical Group Orlando
  - Plantation, Florida, United States, 33324
    - Sylvester Comprehensive Cancer Center Plantation
  - Port Charlotte, Florida, United States, 33980
    - Florida Cancer Specialists
  - Sarasota, Florida, United States, 34236
    - Florida Cancer Specialists
  - St. Petersburg, Florida, United States, 33705
    - Florida Cancer Specialists
  - St. Petersburg, Florida, United States, 33705
    - Florida Cancer Specialists - North Region
  - Stuart, Florida, United States, 34994
    - Florida Cancer Specialists.
  - Tampa, Florida, United States, 33612
    - Moffitt Cancer Center
  - Tampa, Florida, United States, 33607
    - Florida Cancer Specialists
  - Tampa, Florida, United States, 33612
    - Moffitt McKinley Hospital
  - Tampa, Florida, United States, 33612
    - Moffitt Cancer Center, Richard M, Schulze Family Foundation Outpatient Center at McKinley Campus
  - Tavares, Florida, United States, 32778
    - Florida Cancer Specialists
  - The Villages, Florida, United States, 32159
    - Florida Cancer Specialists
  - Trinity, Florida, United States, 34655
    - Florida Cancer Specialists
  - Vero Beach, Florida, United States, 32960
    - Florida Cancer Specialists.
  - Wellington, Florida, United States, 33414
    - Florida Cancer Specialists.
  - West Palm Beach, Florida, United States, 33401
    - Florida Cancer Specialists.
- Georgia
  - Athens, Georgia, United States, 30606
    - Northside Hospital, Inc. - GCS/ Athens
  - Atlanta, Georgia, United States, 30342
    - Atlanta Cancer Care - Atlanta
  - Atlanta, Georgia, United States, 30342
    - Northside Hospital, Inc. - Central Research Department
  - Atlanta, Georgia, United States, 30342
    - Northside Hospital, Inc. - GCS/Northside
  - Atlanta, Georgia, United States, 30322
    - Winship Cancer Institute, Emory University.
  - Augusta, Georgia, United States, 30912
    - Georgia Cancer Center at Augusta University
  - Blairsville, Georgia, United States, 30512
    - Northside Hospital, Inc. - GCS/Blairsville
  - Canton, Georgia, United States, 30115
    - Northside Hospital, Inc. - GCS/Canton
  - Cumming, Georgia, United States, 30041
    - Atlanta Cancer Care - Cumming
  - Macon, Georgia, United States, 31217
    - Northside Hospital, Inc. - GCS/Macon
  - Marietta, Georgia, United States, 30060
    - Northside Hospital, Inc. - GCS/Kennestone
- Hawaii
  - Honolulu, Hawaii, United States, 96826
    - Kapi'olani Medical Center for Women and Children
  - Honolulu, Hawaii, United States, 96819
    - Kaiser Permanente Hawaii
  - Honolulu, Hawaii, United States, 96813
    - Hawai'i Pacific Health Research Institute - Administrative Site
  - Honolulu, Hawaii, United States, 96819
    - Kaiser Permanente Hawaii.
  - Honolulu, Hawaii, United States, 96826
    - Kapi'olani Women's Center
- Illinois
  - Bloomington, Illinois, United States, 61704
    - Illinois CancerCare- Bloomington
  - Chicago, Illinois, United States, 60637
    - University of Chicago Medical Center
  - Chicago, Illinois, United States, 60612
    - Rush University Medical Center, Professional Office Building Infusion Pharmacy
  - Chicago, Illinois, United States, 60612
    - Rush University Medical Center.
  - Chicago, Illinois, United States, 60637
    - University of Chicago Medical Center, CCD- Investigational Drug Service Pharmacy
  - Galesburg, Illinois, United States, 61401
    - Illinois CancerCare - Galesburg
  - New Lenox, Illinois, United States, 60451
    - University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
  - Orland Park, Illinois, United States, 60462
    - Orland Park - University of Chicago Center for Advanced Care
  - Pekin, Illinois, United States, 61554
    - Illinois CancerCare- Pekin
  - Peoria, Illinois, United States, 61615
    - Illinois CancerCare, P.C.
  - Peru, Illinois, United States, 61354
    - Illinois CancerCare- Peru
- Indiana
  - Fort Wayne, Indiana, United States, 46804
    - Ft Wayne Medical Oncology and Hematology, Inc TRIO
- Kansas
  - Kansas City, Kansas, United States, 66112
    - The University of Kansas Cancer Center - West
  - Overland Park, Kansas, United States, 66210
    - The University of Kansas Cancer Center - Overland Park
  - Overland Park, Kansas, United States, 66209
    - MidAmerica Division, Inc. c/o Menorah Medical Center
  - Overland Park, Kansas, United States, 66211
    - The University of Kansas Cancer Center - Indian Creek Campus
  - Overland Park, Kansas, United States, 66211
    - The University of Kansas Cancer Center Breast Surgery Center - Indian Creek Campus
  - Westwood, Kansas, United States, 66205
    - The University of Kansas Cancer Center
  - Westwood, Kansas, United States, 66205
    - The University of Kansas Cancer Center, Investigational Drug Services
- Kentucky
  - Lexington, Kentucky, United States, 40509
    - CHI Saint Joseph Cancer Care
  - Lexington, Kentucky, United States, 40509
    - Saint Joseph Health Infusion Services
- Maryland
  - Baltimore, Maryland, United States, 21202
    - Mercy Medical Center -Weinberg Center
  - Baltimore, Maryland, United States, 21201
    - University of Maryland, Greenebaum Comprehensive Cancer Center.
  - Baltimore, Maryland, United States, 21202
    - Mercy Medical Center.
  - Bethesda, Maryland, United States, 20817
    - Maryland Oncology Hematology, P.A
  - Brandywine, Maryland, United States, 20613
    - Maryland Oncology Hematology, P.A
  - Columbia, Maryland, United States, 21044
    - Maryland Oncology Hematology, P.A
  - Frederick, Maryland, United States, 21702
    - Maryland Oncology Hematology, P.A
  - Largo, Maryland, United States, 20774
    - Maryland Oncology Hematology, P.A
  - Rockville, Maryland, United States, 20850
    - Maryland Oncology Hematology, P.A
  - Silver Spring, Maryland, United States, 20904
    - Maryland Oncology Hematology, P.A
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Dana-Farber Cancer Institute
  - Boston, Massachusetts, United States, 02115
    - Brigham & Women's Hospital
  - Newton, Massachusetts, United States, 02459
    - Dana Farber Cancer Institute- Chestnut Hill
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - University of Michigan
  - Brighton, Michigan, United States, 48116
    - Brighton Center for Specialty Care
  - Detroit, Michigan, United States, 48202
    - Henry Ford Hospital
- Minnesota
  - Edina, Minnesota, United States, 55435
    - Minnesota Oncology Hematology, P.A.
- Missouri
  - City of Saint Peters, Missouri, United States, 63376
    - Siteman Cancer Center - St Peters
  - Creve Coeur, Missouri, United States, 63141
    - Siteman Cancer Center - West County
  - Florissant, Missouri, United States, 63031
    - Siteman Cancer Center - North County
  - Independence, Missouri, United States, 64057
    - MidAmerica Division, Inc. c/o Centerpoint Medical Center
  - Kansas City, Missouri, United States, 64111
    - Saint Luke's Cancer Institute
  - Kansas City, Missouri, United States, 64132
    - MidAmerica Division, Inc., c/o Research Medical Center
  - Kansas City, Missouri, United States, 64111
    - Saint Luke's Hospital Investigational Pharmacy
  - Kansas City, Missouri, United States, 64116
    - The University of Kansas Cancer Center
  - Kansas City, Missouri, United States, 64154
    - The University of Kansas Cancer Center -North
  - Lee's Summit, Missouri, United States, 64064
    - The University of Kansas Cancer Center - Lee's Summit
  - St Louis, Missouri, United States, 63110
    - Barnes-Jewish Hospital
  - St Louis, Missouri, United States, 63129
    - Siteman Cancer Center - South County
  - St Louis, Missouri, United States, 63110
    - Washington University School of Medicine - St. Louis
  - St Louis, Missouri, United States, 63110
    - Washington University School of Medicine - Siteman Cancer Center.
- Montana
  - Billings, Montana, United States, 59101
    - St. Vincent Healthcare
  - Billings, Montana, United States, 59102
    - St. Vincent - Frontier Cancer Center
- Nebraska
  - Omaha, Nebraska, United States, 68130
    - Oncology Hematology West, PC dba Nebraska Cancer Specialists
  - Omaha, Nebraska, United States, 68114
    - Oncology Hematology West, PC dba Nebraska Cancer Specialists
  - Omaha, Nebraska, United States, 68124
    - Oncology Hematology West, PC dba Nebraska Cancer Specialists
  - Omaha, Nebraska, United States, 68130
    - West Omaha Imaging
- Nevada
  - Henderson, Nevada, United States, 89074
    - Comprehensive Cancer Centers of Nevada
  - Henderson, Nevada, United States, 89052
    - Comprehensive Cancer Centers of Nevada
  - Henderson, Nevada, United States, 89119
    - Comprehensive Cancer Centers of Nevada Research Department
  - Las Vegas, Nevada, United States, 89148
    - Comprehensive Cancer Centers of Nevada
  - Las Vegas, Nevada, United States, 89128
    - Comprehensive Cancer Centers of Nevada
  - Las Vegas, Nevada, United States, 89169
    - Comprehensive Cancer Centers of Nevada
  - Las Vegas, Nevada, United States, 89052
    - Comprehensive Cancer Centers of Nevada
  - Las Vegas, Nevada, United States, 89144
    - Comprehensive Cancer Centers of Nevada
- New Jersey
  - Berkeley Heights, New Jersey, United States, 07922
    - Summit Medical Group
  - Florham Park, New Jersey, United States, 07932
    - Summit Medical Group
  - Livingston, New Jersey, United States, 07039
    - Cooperman Barnabas Medical Center
- New York
  - Albany, New York, United States, 12206
    - New York Oncology Hematology, P.C.
  - Stony Brook, New York, United States, 11794
    - Stony Brook University Medical Center
  - Stony Brook, New York, United States, 11794
    - Stony Brook Cancer Center
  - Stony Brook, New York, United States, 11794
    - Stony Brook Advanced Imaging
- North Carolina
  - Charlotte, North Carolina, United States, 28204
    - Levine Cancer Institute
  - Charlotte, North Carolina, United States, 28210
    - Levine Cancer Institute-Pineville
  - Charlotte, North Carolina, United States, 28204
    - Carolinas Medical Center Investigational Drug Services
  - Charlotte, North Carolina, United States, 28203
    - Carolinas Medical Center (biopsy only)
  - Charlotte, North Carolina, United States, 28203
    - Charlotte Radiology Medical Center Plaza Breast Center (biopsy only)
  - Charlotte, North Carolina, United States, 28207
    - Carolinas Medical Center - Mercy (biopsy only)
  - Charlotte, North Carolina, United States, 28210
    - Atrium Health Pineville (biopsy only)
  - Charlotte, North Carolina, United States, 28262
    - Atrium Health University City (biopsy only)
  - Concord, North Carolina, United States, 28025
    - Atrium Health Cabarrus (biopsy only)
  - Concord, North Carolina, United States, 28025
    - Levine Cancer Institute Concord
  - Durham, North Carolina, United States, 27710
    - Duke University Medical Center
  - Monroe, North Carolina, United States, 28112
    - Atrium Health Union (biopsy only)
- Oregon
  - Beaverton, Oregon, United States, 97006
    - OHSU Knight Cancer Institute, Beaverton
  - Clackamas, Oregon, United States, 97015
    - Providence Cancer Institute Clackamas Clinic
  - Gresham, Oregon, United States, 97030
    - OHSU Knight Cancer Institute, Gresham
  - Portland, Oregon, United States, 97239
    - Oregon Health and Science University
  - Portland, Oregon, United States, 97213
    - Providence Cancer Institute Franz Clinic
  - Portland, Oregon, United States, 97213
    - Providence Portland Medical Center
  - Portland, Oregon, United States, 97239
    - OHSU Center for Health and Healing 2
  - Portland, Oregon, United States, 97239
    - OHSU Center for Health and Healing
  - Portland, Oregon, United States, 97239
    - OHSU Research Pharmacy Services
  - Portland, Oregon, United States, 97210
    - OHSU Knight Cancer Institute, Northwest Portland
  - Portland, Oregon, United States, 97216
    - OHSU Knight Cancer Institute, East Portland
  - Portland, Oregon, United States, 97213
    - Northwest Cancer Specialists P.C.
  - Portland, Oregon, United States, 97227
    - Northwest Cancer Specialists P.C.
  - Tigard, Oregon, United States, 97223
    - Northwest Cancer Specialists, P.C.
  - Tualatin, Oregon, United States, 97062
    - OHSU Knight Cancer Institute, Tualatin
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19104
    - Hospital of the University of Pennsylvania, Perelman Center for Advanced Medicine
- Tennessee
  - Dickson, Tennessee, United States, 37055
    - Tennessee Oncology PLLC
  - Franklin, Tennessee, United States, 37067
    - Tennessee Oncology PLLC
  - Gallatin, Tennessee, United States, 37066
    - Tennessee Oncology PLLC
  - Hendersonville, Tennessee, United States, 37075
    - Tennessee Oncology PLLC
  - Hermitage, Tennessee, United States, 37076
    - Tennessee Oncology PLLC
  - Knoxville, Tennessee, United States, 37909
    - Brig Center for Cancer Care and Survivorship
  - Lebanon, Tennessee, United States, 37090
    - Tennessee Oncology PLLC
  - Murfreesboro, Tennessee, United States, 37129
    - Tennessee Oncology PLLC
  - Nashville, Tennessee, United States, 37203
    - Tennessee Oncology PLLC
  - Nashville, Tennessee, United States, 37203
    - The Sarah Cannon Research Institute
  - Nashville, Tennessee, United States, 37205
    - Tennessee Oncology PLLC
  - Nashville, Tennessee, United States, 37207
    - Tennessee Oncology PLLC
  - Nashville, Tennessee, United States, 37211
    - Tennessee Oncology PLLC
  - Shelbyville, Tennessee, United States, 37160
    - Tennessee Oncology PLLC
  - Smyrna, Tennessee, United States, 37167
    - Tennessee Oncology PLLC
- Texas
  - Amarillo, Texas, United States, 79124
    - Texas Oncology - West Texas
  - Arlington, Texas, United States, 76014
    - The Center for Cancer and Blood Disorders
  - Austin, Texas, United States, 78731
    - Texas Oncology - Austin
  - Austin, Texas, United States, 78745
    - Texas Oncology - Austin
  - Bedford, Texas, United States, 76022
    - Texas Oncology - DFWW
  - Bedford, Texas, United States, 76022
    - Texas Oncology - DFW
  - Burleson, Texas, United States, 76028
    - The Center for Cancer and Blood Disorders
  - Dallas, Texas, United States, 75390
    - University of Texas Southwestern Medical Center
  - Dallas, Texas, United States, 75235
    - Parkland Health and Hospital System
  - Dallas, Texas, United States, 75390
    - UT Southwestern University Hospital - Zale Lipshy
  - Dallas, Texas, United States, 75390
    - UT Southwestern Medical Center - Simmons Cancer Center
  - Dallas, Texas, United States, 75390
    - UT Southwestern University Hospital - William P. Clements, Jr
  - Dallas, Texas, United States, 75246
    - Texas Oncology - DFW
  - Dallas, Texas, United States, 75203
    - Texas Oncology - DFW
  - Dallas, Texas, United States, 75246
    - Texas Oncology - DFWW
  - Dallas, Texas, United States, 75390
    - UT Southwestern Medical Center - Simmons Cancer Center Pharmacy
  - Fort Worth, Texas, United States, 76104
    - The Center for Cancer and Blood Disorders
  - Fort Worth, Texas, United States, 76104
    - UT Southwestern Medical Center - d/b/a Moncrief Cancer Institute - Ft. Worth - Pharmacy
  - Fort Worth, Texas, United States, 76104
    - UT Southwestern Medical Center d/b/a Moncrief Cancer Institute - Ft. Worth
  - Houston, Texas, United States, 77030
    - Baylor St. Luke's Medical Center
  - Houston, Texas, United States, 77030
    - Baylor College of Medicine Medical Center
  - Houston, Texas, United States, 77030
    - Oncology Consultants, P.A.
  - Houston, Texas, United States, 77054
    - Harris Health System - Smith Clinic
  - Houston, Texas, United States, 77024
    - Oncology Consultants, P.A.
  - Houston, Texas, United States, 77024
    - Texas Oncology - Gulf Coast
  - Houston, Texas, United States, 77030
    - Harris Health System - Ben Taub General Hospital
  - New Braunfels, Texas, United States, 78130
    - Texas Oncology - San Antonio
  - Richardson, Texas, United States, 75080
    - UT Southwestern Medical Center - Clinical Center Richardson/Plano - Pharmacy
  - Richardson, Texas, United States, 75080
    - UT Southwestern Medical Center - Clinical Center Richardson/Plano
  - San Antonio, Texas, United States, 78217
    - Texas Oncology-San Antonio
  - San Antonio, Texas, United States, 78240
    - Texas Oncology-San Antonio
  - San Antonio, Texas, United States, 78258
    - Texas Oncology-San Antonio
  - Weatherford, Texas, United States, 76086
    - The Center for Cancer and Blood Disorders
- Utah
  - Farmington, Utah, United States, 84025
    - University of Utah, Farmington Health Center
  - Salt Lake City, Utah, United States, 84112
    - University of Utah, Huntsman Cancer Institute
  - Salt Lake City, Utah, United States, 84112
    - University of Utah, Huntsman Cancer Hospital
  - Salt Lake City, Utah, United States, 84106
    - University of Utah, Sugar House Health Center
  - South Jordan, Utah, United States, 84009
    - University of Utah, South Jordan Health Center
- Virginia
  - Alexandria, Virginia, United States, 22304
    - Virginia Cancer Specialists, PC
  - Arlington, Virginia, United States, 22201
    - Virginia Cancer Specialists, PC
  - Blacksburg, Virginia, United States, 24060
    - Oncology & Hematology Associates of Southwest Virginia,Inc.DBA Blue Ridge Cancer Care
  - Fairfax, Virginia, United States, 22031
    - Virginia Cancer Specialists, PC
  - Gainesville, Virginia, United States, 20155
    - Virginia Cancer Specialists, PC
  - Leesburg, Virginia, United States, 20176
    - Virginia Cancer Specialists, PC
  - Low Moor, Virginia, United States, 24457
    - Oncology and Hematology Associates of Southwest Virginia Inc
  - Roanoke, Virginia, United States, 24014
    - Oncology & Hematology Associates of Southwest Virginia,Inc.DBA Blue Ridge Cancer Care
  - Salem, Virginia, United States, 24153
    - Oncology & Hematology Associates of Southwest Virginia,Inc.DBA Blue Ridge Cancer Care
  - Wytheville, Virginia, United States, 24382
    - Oncology and Hematology Associates of Southwest Virginia Inc
- Washington
  - Issaquah, Washington, United States, 98029
    - Swedish Cancer Institute - Issaquah Campus
  - Vancouver, Washington, United States, 98684
    - Northwest Cancer Specialists P.C.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:
- 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
- CNS Inclusion - Based on screening contrast brain magnetic resonance imaging (MRI), participants must have at least one of the following:
  (a) No evidence of brain metastases
  (b) Untreated brain metastases not needing immediate local therapy
  (c) Previously treated brain metastases
  1. 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
  2. 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
  3. Relevant records of any CNS treatment must be available to allow for classification of target and non-target lesions
Exclusion Criteria:
- 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).
- CNS Exclusion - Based on screening contrast brain magnetic resonance imaging (MRI), participants must not have any of the following:
  1. Any untreated brain lesions >2 cm in size
  2. Ongoing use of 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
  4. Known or concurrent leptomeningeal disease as documented by the investigator
  5. Poorly controlled generalized or complex partial seizures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tucatinib + T-DM1	Drug: tucatinib 300mg given twice per day by mouth (orally) Other Names: ONT-380 Drug: T-DM1 3.6 mg/kg given into the vein (IV; intravenously) every 21 days Other Names: Kadcyla
Active Comparator: Placebo + T-DM1	Drug: T-DM1 3.6 mg/kg given into the vein (IV; intravenously) every 21 days Other Names: Kadcyla Drug: placebo Given twice per day orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1 Based on Investigator Assessment Time Frame: 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)	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) Time Frame: Up to approximately 5 years	OS was defined as the time from randomization to death due to any cause. For a participant who was not known to have died by the end of study follow-up, observation of OS was censored on the date the participant was last known to be alive (i.e., the date of last contact).	Up to approximately 5 years
Progression-Free Survival as Per RECIST v1.1 in Participants With Brain Metastases at Baseline Based on Investigator Assessment Time Frame: 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)	PFS as per investigator was defined as the time from the date of randomization to the investigator assessment of PD as per RECIST v1.1 or death from any cause, whichever occurred first. PD: at least a 20 % 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 mm. Participants without documentation of PD, or death at the time of analysis were censored at the date of the last tumor assessment. PFS was analyzed in participants with presence or history of brain metastases.	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 Time Frame: 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)	ORR was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to less than (<)10 mm. PR: a greater than equal (>=) 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response. ORR by investigator assessment is based on investigator response assessments. Two-sided 95% exact confidence interval, computed using the Clopper-Pearson method.	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 Time Frame: Up to approximately 5 years	OS was defined as the time from randomization to death due to any cause. For a participant who was not known to have died by the end of study follow-up, observation of OS was censored on the date the participant was last known to be alive (i.e., the date of last contact). OS was analyzed in participants with presence or history of brain metastases.	Up to approximately 5 years
Progression-Free Survival as Per RECIST v1.1 Determined by Blinded Independent Committee Review (BICR) Time Frame: 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)	PFS as per BICR was defined as the time from the date of randomization to the centrally-reviewed documented PD as per RECIST v1.1 or death from any cause, whichever occurred first. PD: at least a 20 % 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 mm. Participants without documented progression 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)
Progression-Free Survival in Participants With Brain Metastases at Baseline as Per RECIST v1.1 Determined by BICR Time Frame: 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)	PFS as per BICR was defined as the time from the date of randomization to the centrally-reviewed documented PD as per RECIST v1.1 or death from any cause, whichever occurred first. PD: at least a 20 % 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 mm. PFS was analyzed in participants with presence or history of brain metastases.	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)
Objective Response Rate as Per RECIST v1.1 Determined by BICR Time Frame: 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)	ORR was defined as the percentage of participants with confirmed CR or PR according to RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: A >= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR per BICR is based on BICR response assessments.	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)
Duration of Response (DOR) as Per RECIST v1.1 Based on Investigator Assessment Time Frame: Up to approximately 5 years	DOR was defined as the time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of PD as per RECIST v1.1 PD: at least a 20 % 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 mm. Participants without documentation of PD, or death at the time of analysis were censored at the date of the last tumor assessment. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: A>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. DOR per investigator was based on investigator response assessments.	Up to approximately 5 years
Duration of Response as Per RECIST v1.1 by BICR Time Frame: Up to approximately 5 years	DOR was defined as the time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of PD as per RECIST v1.1 PD: at least a 20 % 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 mm. Participants without documentation of PD, or death at the time of analysis were censored at the date of the last tumor assessment. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: A>=30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. DOR per BICR was based on BICR response assessments.	Up to approximately 5 years
Clinical Benefit Rate (CBR) Per RECIST v1.1 Based on Investigator Assessment Time Frame: Up to approximately 5 years	CBR was defined as the percentage of participants with stable disease (SD) or non-CR or non-PD >= 6 months or best response of CR or PR according to RECIST v1.1. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: A >= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CBR was based on investigator assessment.	Up to approximately 5 years
Clinical Benefit Rate as Per RECIST v1.1 by BICR Time Frame: Up to approximately 5 years	CBR was defined as the percentage of participants with SD or non-CR or non-PD >= 6 months or best response of CR or PR according to RECIST v1.1. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: A >= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CBR per BICR is based on BICR response assessments.	Up to approximately 5 years
Number of Participants With Treatment Emergent Adverse Events (AEs) Time Frame: From start of treatment up to 30 days after the last study treatment (approximately 43 months)	An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE was defined as AE that is newly occurred or worsened after the start of study treatment.	From start of treatment up to 30 days after the last study treatment (approximately 43 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen, a wholly owned subsidiary of Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Helpful Links

To obtain contact information for a study center near you, click here.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2019

Primary Completion (Actual)

June 29, 2023

Study Completion (Estimated)

March 10, 2029

Study Registration Dates

First Submitted

June 4, 2019

First Submitted That Met QC Criteria

June 4, 2019

First Posted (Actual)

June 5, 2019

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

SGNTUC-016
2024-514733-38-00 (Registry Identifier: CTIS (EU))
C4251001 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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More Information

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Keywords

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Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on HER2-positive Breast Cancer

Clinical Trials on tucatinib

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