Colorectal NeoplasmsPhase 3MOUNTAINEER-03NCT05253651
A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer
A Phase 3 study testing tucatinib, trastuzumab and bevacizumab in people with Colorectal Neoplasms, run by Seagen, a wholly owned subsidiary of Pfizer at 366 sites in 25 countries.
Trial summary
This study is being done to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also determine what side effects happen when participants take this combination of drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- tucatinib, trastuzumab and bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 366 sitesin 25 countries
- Study dates
- 24 Oct 2022to 3 Jul 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically and/or cytologically confirmed adenocarcinoma of the colon or rectum which is locally advanced unresectable or metastatic
- Able to provide the most recently available formalin-fixed paraffin-embedded (FFPE) tumor tissue blocks (or freshly sectioned slides) obtained prior to treatment initiation to a central laboratory
- If archival tissue is not available, a newly-obtained baseline biopsy of an accessible tumor lesion is required within 35 days prior to start of study treatment
- HER2+ disease as determined by a tissue based assay performed at a central laboratory.
- Participant has rat sarcoma viral oncogene homolog wild-type (RAS WT) disease as determined by local or central testing. For central RAS analysis, tissue sample must be analyzed within 1 year of biopsy date.
- Radiographically measurable disease per RECIST v1.1 with:
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- At least one site of disease that is measurable and that has not been previously irradiated, or
- If the participant has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- CNS Inclusion - based on contrast brain magnetic resonance imaging, participants may have any of the following:
- No evidence of brain metastases
- Previously treated brain metastases which are asymptomatic
Who cannot join
- Prior systemic anticancer therapy for colorectal cancer (CRC) in the locally advanced unresectable or metastatic setting; note that participants may have received a maximum of 2 doses of mFOLFOX6 in the locally advanced/unresectable or metastatic setting prior to randomization.
- Note: May have received chemotherapy for CRC in the adjuvant setting if it was completed >6 months prior to enrollment
- Radiation therapy within 14 days prior to enrollment (or within 7 days in the setting of stereotactic radiosurgery)
- Previous treatment with anti-HER2 therapy
- Ongoing Grade 3 or higher neuropathy
- Active or untreated gastrointestinal (GI) perforation at the time of screening.
Trial locations and contacts
366 sites in 25 countries. Contact the study team or a site near you to ask about taking part.
366 sites in 25 countries
United States132 sites, 108 recruiting
- Recruiting
Los Angeles Cancer Network - Anaheim
Anaheim, California, 92801
- Active, not recruiting
Kaiser Permanente Anaheim Kraemer Medical Offices
Anaheim, California, 92806
- Recruiting
Emory University Hospital Midtown
Atlanta, Georgia, 30308
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
- Recruiting
Winship Cancer Institute
Atlanta, Georgia, 30322
- Recruiting
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
- Recruiting
Rocky Mountain Cancer Centers, LLP
Aurora, Colorado, 80012
- Recruiting
Mount Sinai Medical Center Aventura ER
Aventura, Florida, 33180
- Active, not recruiting
Kaiser Permanente Baldwin Park Medical Center
Baldwin Park, California, 91706
- Recruiting
MSK Basking Ridge
Basking Ridge, New Jersey, 07920
- Recruiting
UPMC Hillman Cancer Center - Beaver
Beaver, Pennsylvania, 15009
- Active, not recruiting
Kaiser Permanente Bellflower Medical Offices
Bellflower, California, 90706
- Recruiting
Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care
Blacksburg, Virginia, 24060
- Recruiting
Rocky Mountain Cancer Centers, LLP
Boulder, Colorado, 80303
- Recruiting
Minnesota Oncology Hematology, PA
Burnsville, Minnesota, 55337
- Recruiting
UPMC Hillman Cancer Center at Butler Health System
Butler, Pennsylvania, 16001
- Terminated
Gabrail Cancer Center Research
Canton, Ohio, 44718
- Recruiting
Rocky Mountain Cancer Centers, LLP
Colorado Springs, Colorado, 80907
- Recruiting
MSK Commack
Commack, New York, 11725
- Recruiting
Allina Health Cancer institute
Coon Rapids, Minnesota, 55433
- Recruiting
Minnesota Oncology Hematology, PA
Coon Rapids, Minnesota, 55433
- Recruiting
Texas Oncology - DFW
Dallas, Texas, 75246
- Recruiting
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, 80218
- Recruiting
Rocky Mountain Cancer Centers, LLP
Denver, Colorado, 80220
- Recruiting
Duke University Hospital
Durham, North Carolina, 27710
- Recruiting
Duke University Medical Center, Duke Cancer Center
Durham, North Carolina, 27710
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
- Recruiting
M Health Fairview Cancer Clinic-Edina
Edina, Minnesota, 55435
- Recruiting
Minnesota Oncology Hematology, PA
Edina, Minnesota, 55435
- Recruiting
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, 16505
- Recruiting
Providence Regional Cancer Partnership
Everett, Washington, 98201
- Recruiting
Providence Regional Medical Center Everett
Everett, Washington, 98201
- Active, not recruiting
Kaiser Permanente Fontana Medical Center
Fontana, California, 92335
- Recruiting
Los Angeles Cancer Network - Fountain Vally
Fountain Valley, California, 92708
- Recruiting
Minnesota Oncology Hematology, PA
Fridley, Minnesota, 55432
- Recruiting
Palo Verde Hematology Oncology
Glendale, Arizona, 85304
- Recruiting
Los Angeles Cancer Network - Corporate Office
Glendale, California, 91204
- Recruiting
Los Angeles Hematology Oncology Medical Group
Glendale, California, 91204
- Recruiting
Los Angeles Hematology Oncology Medical Group
Glendale, California, 91206
- Recruiting
UPMC Hillman Cancer Center at Arnold Palmer Pavilion, In Partnership with Excela Health
Greensburg, Pennsylvania, 15601
- Recruiting
Northwest Cancer Specialists, P.C
Happy Valley, Oregon, 97015
- Active, not recruiting
Kaiser Permanente South Bay Medical center
Harbor City, California, 90710
- Recruiting
UPMC Hillman Cancer Center - Pinnacle (Community Osteopathic / Medical Sciences Pavillion)
Harrisburg, Pennsylvania, 17109
- Recruiting
MSK Westchester
Harrison, New York, 10604
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
- Active, not recruiting
Kaiser Permanente Alton/Sand Canyon Medical Offices
Irvine, California, 92618
- Recruiting
US Oncology Investigational Product Center (IPC)
Irving, Texas, 75063
- Recruiting
US Oncology Investigational Products Center (IPC)
Irving, Texas, 75063
- Recruiting
UPMC Hillman Cancer Center at Arnold Palmer Pavilion, In Partnership with Excela Health
Irwin, Pennsylvania, 15642
- Recruiting
Rocky Mountain Cancer Centers, LLP
Lakewood, Colorado, 80228
- Recruiting
Rocky Mountain Cancer Centers, LLP
Littleton, Colorado, 80120
- Recruiting
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, 80124
- Recruiting
Rocky Mountain Cancer Centers, LLP
Longmont, Colorado, 80504
- Recruiting
Los Angeles Hematology Oncology Medical Group
Los Angeles, California, 90017
- Terminated
USC Norris Koreatown - Medical Oncology
Los Angeles, California, 90020
- Active, not recruiting
Kaiser Permanente Los Angeles Medical Offices
Los Angeles, California, 90027
- Terminated
Keck Hospital of USC
Los Angeles, California, 90033
- Terminated
Los Angeles General Medical Center
Los Angeles, California, 90033
- Terminated
University of Southern California
Los Angeles, California, 90033
- Terminated
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
- Active, not recruiting
Kaiser Permanente West Los Angeles Medical Center
Los Angeles, California, 90034
- Recruiting
Norton Cancer Institute - Downtown
Louisville, Kentucky, 40202
- Recruiting
Norton Cancer Institute, Downtown
Louisville, Kentucky, 40202
- Recruiting
Norton Hospital
Louisville, Kentucky, 40202
- Recruiting
Norton Audubon Hospital
Louisville, Kentucky, 40217
- Recruiting
Norton Cancer Institute, Audubon Hospital Campus
Louisville, Kentucky, 40217
- Recruiting
Norton Brownsboro Hospital
Louisville, Kentucky, 40241
- Recruiting
Norton Cancer Institute, Brownsboro Hospital Campus
Louisville, Kentucky, 40241
- Recruiting
Oncology & Hematology Associates of Southwest Virginia
Low Moor, Virginia, 24457
- Recruiting
Minnesota Oncology Hematology, PA
Maple Grove, Minnesota, 55369
- Recruiting
M Health Fairview St. John's Hospital
Maplewood, Minnesota, 55109
- Recruiting
Minnesota Oncology Hematology, PA
Maplewood, Minnesota, 55109
- Recruiting
UPMC Hillman Cancer Center - Pinnacle (Ortenzio)
Mechanicsburg, Pennsylvania, 17050
- Terminated
Alliance for Multispecialty Research LLC.
Merriam, Kansas, 66204
- Recruiting
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
- Recruiting
Mount Sinai Medical Center
Miami Beach, Florida, 33140
- Recruiting
MSK Monmouth
Middletown, New Jersey, 07748
- Recruiting
Allina Health Cancer Institute (Virginia Piper Cancer Institute)
Minneapolis, Minnesota, 55404
- Recruiting
Minnesota Oncology Hematology, PA
Minneapolis, Minnesota, 55404
- Recruiting
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
- Recruiting
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania, 15146
- Recruiting
MSK Bergen
Montvale, New Jersey, 07645
- Recruiting
Henry-Joyce Cancer Clinic
Nashville, Tennessee, 37232
- Recruiting
Rockefeller Outpatient Pavilion (53rd Street)
New York, New York, 10022
- Recruiting
Memorial Solan Kettering Cancer Center- Main Campus
New York, New York, 10065
- Recruiting
Providence Cancer Institute Newberg Clinic
Newberg, Oregon, 97132
- Terminated
USC Norris Oncology/Hematology - Newport Beach
Newport Beach, California, 92663
- Active, not recruiting
Kaiser Permanente Ontario Medical Center
Ontario, California, 91761
- Recruiting
Providence Cancer Institute Willamette Falls Clinic
Oregon City, Oregon, 97045
- Active, not recruiting
Kaiser Permanente Panorama City Medical Center
Panorama City, California, 91402
- Terminated
Keck Medical Center of USC Pasadena
Pasadena, California, 91105
- Recruiting
Los Angeles Hematology Oncology Medical Group
Pasadena, California, 91105
- Recruiting
Mayo Clinic Building - Phoenix
Phoenix, Arizona, 85054
- Recruiting
Mayo Clinic Hospital
Phoenix, Arizona, 85054
- Recruiting
FirstHealth Cancer Center
Pinehurst, North Carolina, 28374
- Recruiting
FirstHealth Moore Regional Hospital
Pinehurst, North Carolina, 28374
- Recruiting
UPMC Hillman Cancer Center - St Margarets
Pittsburgh, Pennsylvania, 15215
- Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
- Recruiting
UPMC Hillman Cancer Center - Passavant (HOA)
Pittsburgh, Pennsylvania, 15237
- Recruiting
St. Clair Cancer Center Medical Oncology
Pittsburgh, Pennsylvania, 15243
- Recruiting
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213
- Recruiting
Providence Portland Medical Center
Portland, Oregon, 97213
- Recruiting
Providence Oncology and Hematology Care Clinic - Westside
Portland, Oregon, 97225
- Recruiting
Providence Portland Medical Center-Westside
Portland, Oregon, 97225
- Recruiting
Providence St. Vincent Medical Center- Investigational Drug Services
Portland, Oregon, 97225
- Recruiting
Providence St. Vincent Medical Center
Portland, Oregon, 97225
- Recruiting
Northwest Cancer Specialists, P.C.
Portland, Oregon, 97227
- Recruiting
Rocky Mountain Cancer Centers, LLP
Pueblo, Colorado, 81003
- Active, not recruiting
Kaiser Permanente Riverside Medical Center
Riverside, California, 92505
- Recruiting
Oncology & Hematology Associates of Southwest Virginia Inc dba Blue Ridge Cancer Care
Roanoke, Virginia, 24014
- Recruiting
North Memorial Health Cancer Center
Robbinsdale, Minnesota, 55422
- Recruiting
Mayo Clinic Cancer Center Outpatient Pharmacy
Rochester, Minnesota, 55905
- Recruiting
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, 55416
- Recruiting
Park Nicollet Frauenshuh Cancer Center
Saint Louis Park, Minnesota, 55426
- Recruiting
Regulatory Location: MMCORC
Saint Louis Park, Minnesota, 55426
- Recruiting
Regions Hospital
Saint Paul, Minnesota, 55101
- Recruiting
Allina Health Cancer Institute-United(VPCI)
Saint Paul, Minnesota, 55102
- Recruiting
Oncology & Hematology Associates of Southwest Virginia, Inc. D.B.A Blue Ridge Cancer Care
Salem, Virginia, 24153
- Active, not recruiting
Kaiser Permanente San Diego Mission Road (Regulatory and Lab Supplies)
San Diego, California, 92108
- Active, not recruiting
Kaiser Permanente Zion Medical Center
San Diego, California, 92120
- Active, not recruiting
Kaiser Permanente San Marcos Medical Offices
San Marcos, California, 92078
- Recruiting
Mayo Clinic
Scottsdale, Arizona, 85259
- Recruiting
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
- Recruiting
Rocky Mountain Cancer Centers, LLP
Thornton, Colorado, 80260
- Recruiting
Northwest Cancer Specialists, P.C.
Tigard, Oregon, 97223
- Recruiting
MSK Nassau
Uniondale, New York, 11553
- Recruiting
Los Angeles Hematology Oncology Medical Group
Van Nuys, California, 91405
- Recruiting
Northwest Cancer Specialists, P.C.
Vancouver, Washington, 98684
- Recruiting
UPMC Hillman Cancer Center - Washington
Washington, Pennsylvania, 15301
- Recruiting
Minnesota Oncology Hematology, PA Cornerstone Medical Specialty Center
Woodbury, Minnesota, 55125
- Active, not recruiting
Kaiser Permanente Woodland Hills Medical Center
Woodland Hills, California, 91367
- Recruiting
Oncology & Hematology Associates of Southwest Virginia
Wytheville, Virginia, 24382
China30 sites, 1 recruiting
- Active, not recruiting
Beijing Cancer Hospital
Beijing, 100142
- Active, not recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
- Active, not recruiting
Hunan Cancer Hospital
Changsha, 410013
- Active, not recruiting
The First People's Hospital of Changzhou
Changzhou, Jiangsu, 213003
- Active, not recruiting
Affiliated Hospital of Chengde Medical University
Chengde, Hebei, 067000
- Active, not recruiting
Affiliated Hospital of Chengde Medical University
Chengde, Hebei, 067055
- Active, not recruiting
Army Specialty Medical Center of The Chinese People's Liberation Army
Chongqing, 400042
- Active, not recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
- Active, not recruiting
The Sixth Affiliated hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
- Active, not recruiting
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, 570216
- Active, not recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
- Active, not recruiting
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
- Active, not recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
- Active, not recruiting
Jinan Central Hospital
Jinan, Shandong, 250013
- Active, not recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
- Active, not recruiting
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, 121001
- Active, not recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
- Active, not recruiting
LinYi Cancer Hospital
Linyi, Shandong, 276034
- Active, not recruiting
Meizhou People's hospital
Meizhou, Guangdong, 514031
- Active, not recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
- Recruiting
Nanyang Second General Hospital
Nanyang, Henan, 473009
- Active, not recruiting
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092
- Active, not recruiting
Shanghai General Hospital
Shanghai, 201620
- Active, not recruiting
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110042
- Active, not recruiting
The First Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, 215031
- Active, not recruiting
Shanxi Province Cancer Hospital
Taiyuan, Shanxi, 030013
- Active, not recruiting
Tangshan People's Hospital
Tangshan, Hebei, 063001
- Active, not recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430000
- Active, not recruiting
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221009
- Active, not recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Spain24 sites, 24 recruiting
- Recruiting
Hospital General Universitario de Alicante
Alicante, 03010
- Recruiting
CETIR Viladomat
Barcelona, Other, 08029
- Recruiting
Radiology: CETIR Ascires
Barcelona, 08029
- Recruiting
Data review: Vall d'Hebron institute of Oncology (VHIO).
Barcelona, 08035
- Recruiting
Hospital Vall d'Hebron Unidad de Farmacia de Ensayos Clinicos Oncohematologia
Barcelona, 08035
- Recruiting
Hospital Vall d'Hebron
Barcelona, 08035
- Recruiting
Hospital Clinic de Barcelona
Barcelona, 08036
- Recruiting
Hospital Universitario Reina Sofia
Córdoba, 14004
- Recruiting
Hospital Duran i Reynals - Institut Catala d'Oncologia L'Hospitalet (ICO L'Hospitalet)
L'Hospitalet de Llobregat, Barcelona, 08908
- Recruiting
Hospital Universitari Arnau de Vilanova
Lleida, 25198
- Recruiting
Hospital General Universitario Gregorio Maranon
Madrid, 28007
- Recruiting
Hospital Universitario Ramon y Cajal
Madrid, 28034
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
- Recruiting
Hospital Regional Universitario de Malaga (Hospital Civil)
Málaga, 29011
- Recruiting
Complejo Hospitalario Universitario de Ourense
Ourense, 32005,
- Recruiting
Hospital Universitario Central de Asturias
Oviedo, 33011
- Recruiting
Complejo Hospitalario de Navarra
Pamplona, 31008
- Recruiting
Complejo Hospitalario Universitario de Canarias
San Cristóbal de La Laguna, Santa CRUZ DE Tenerife, 38320
- Recruiting
Hospital Universitario Marques de Valdecilla
Santander, 39008
- Recruiting
Hospital Universitario Virgen del Rocio
Seville, 41013
- Recruiting
Hospital General Universitario de Valencia
Valencia, 46014
- Recruiting
Hospital Quiron Salud Zaragoza
Zaragoza, 50006
- Recruiting
Hospital Universitario Miguel Servet
Zaragoza, 50009
Italy23 sites, 23 recruiting
- Recruiting
UOC Oncologia Medica - Dipartimento Onco Ematologico AORN San Giuseppe Moscati di Avellino
Avellino, Campania, 83100
- Recruiting
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, Lombardy, 25124
- Recruiting
UOC Oncologia Medica, ARNAS GARIBALDI - PRESIDIO OSPEDALIERO NESIMA
Catania, Sicily, 95122
- Recruiting
SODc Oncologia Medica e Clinica, AOU Careggi
Florence, Tuscany, 50134
- Recruiting
Struttura Semplice Dipartimentale di Oncologia Medica e Terapia Biomolecolare Azienda Ospedaliero
Foggia, 71122
- Recruiting
IRCCS Azienda Ospedaliera Metropolitana (IRCCS AOM)
Genova, 16132
- Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Lombardy, 20133
- Recruiting
lstituto Europeo di Oncologia
Milan, Lombardy, 20141
- Recruiting
Niguarda Cancer Center Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, Lombardy, 20162
- Recruiting
Azienda Ospedaliera Universitaria Cagliari
Monserrato, Cagliari, 09042
- Recruiting
Farmacia AOU Cagliari - Presidio Ospedaliero ' Duilio Casula' di Monserrate
Monserrato, Cagliari, 09042
- Recruiting
UOC Oncoematologia
Naples, Naples, 80131
- Recruiting
A.O.U. San Luigi Gonzaga
Orbassano, Turin, 10043
- Recruiting
Istituto Oncologico Veneto - IRCCS
Padova, Veneto, 35128
- Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
- Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, 56126
- Recruiting
S.C Oncologia Arcispedale Santa Maria Nuova
Reggio Emilia, 42123
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, 00168
- Recruiting
ASST della Valtellina e dell'alto Lario - Presidio Ospedaliero di Sondrio
Sondrio, 23100
- Recruiting
UOC Oncologia, Azienda Ospedaliera Cardinale Giovanni Panico
Tricase, Lecce, 73039
- Recruiting
Servizio Farmacia Azienda Ospedaliera Universitaria lntegrata (AOUI) di Verona
Verona, Other, 37134
- Recruiting
Centro ricerche cliniche di Verona SRL
Verona, 37134
- Recruiting
U.O.C. Oncologia Azienda Ospedaliera Universitaria lntegrata (AOUI) di Verona
Verona, 37134
France20 sites, 19 recruiting
- Recruiting
Institut Sainte Catherine
Avignon, 84918
- Recruiting
Centre Hospitalier Regional et Universitaire de Besancon - Hopital Jean-Minjoz
Besançon, Other, 25000
- Recruiting
CHU Brest Hopital Cavale Blanche
Brest, 29200
- Recruiting
CHU Estaing
Clermont-Ferrand, 63100
- Recruiting
Hopital Henri Mondor
Créteil, 94000
- Terminated
Center Georges-Francois Leclerc
Dijon, 21079
- Recruiting
Hopital Edouard Herriot
Lyon, 69437
- Recruiting
Höpital Saint-Joseph
Marseille, 13285
- Recruiting
Centre Hospitalier Universitaire Nantes-Hotel Dieu
Nantes, 44093
- Recruiting
Centre Antoine Lacassagne
Nice, 06189
- Recruiting
Hopital Saint-Louis
Paris, 75010
- Recruiting
Hopital Saint-Antoine
Paris, 75012
- Recruiting
Hopital Europeen Georges Pompidou
Paris, 75015
- Not yet recruiting
CHU Bordeaux Hopital Haut Leveque
Pessac, 33604
- Recruiting
CHU Poitiers
Poitiers, 86000
- Not yet recruiting
CHU de Rouen
Rouen, 76031
- Recruiting
Institut de Cancérologie de l'Ouest - Saint-Herblain
Saint-Herblain, 44805 Cedex
- Recruiting
Centre Hospitalier Universitaire Sainte-Etienne - Hopital Nord
Saint-Priest-en-Jarez, 42270
- Recruiting
Institut de Cancerologie Strasbourg Europe
Strasbourg, 67033
- Recruiting
CHU Toulouse-Rangueil
Toulouse, 31059
Japan18 sites, 17 recruiting
- Recruiting
Chiba Cancer Center
Chiba, Chiba, 260-8717
- Recruiting
National Cancer Center Hospital
Chuo-Ku, Tokyo, 104-0045
- Recruiting
National Hospital Organization Kyushu Cancer Center
Fukuoka, Fukuoka, 811-1395
- Recruiting
National Cancer Center Hospital East
Kashiwa-shi, Chiba, 277-8577
- Recruiting
St. Marianna University Hospital
Kawasaki-shi, Kanagawa, 216-8511
- Recruiting
Kagawa University Hospital
Kita-gun, Kagawa-ken, 761-0793
- Recruiting
Saitama Cancer Center
Kitaadachi-gun, Saitama, 362-0806
- Recruiting
Kobe City Hospital Organization Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047
- Recruiting
Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, 135-8550
- Active, not recruiting
NHO Shikoku Cancer Center
Matsuyama, Ehime, 791-0280
- Recruiting
Osaka General Medical Center
Osaka, Osaka, 558-8558
- Recruiting
National Hospital Organization Osaka National Hospital
Osaka, 540-0006
- Recruiting
Kindai University Hospital
Osakasayama-shi, Osaka, 589-8511
- Recruiting
Kindai University Hospital
Sakai, Osaka, 590-0197
- Recruiting
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648
- Recruiting
The University of Osaka Hospital
Suita, Osaka, 565-0871
- Recruiting
Osaka Medical and Pharmaceutical University Hospital
Takatsuki-shi, Osaka, 569-8686
- Recruiting
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515
Germany16 sites, 15 recruiting
- Recruiting
Klinikum St. Marien Amberg
Amberg, 92224
- Recruiting
Charité - Universitätsmedizin Berlin Campus Virchiow-Klinikum Zentralapotheke
Berlin, 13353
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin, 13353
- Recruiting
Klinikum Chemnitz gGmbH
Chemnitz, 09116
- Recruiting
Gemeinschaftspraxis Hämatologie - Onkologie
Dresden, 01307
- Recruiting
Technische Universität Dresden, Medizinische Fakultät Carl Gustav Carus
Dresden, 01307
- Recruiting
Hämatologisch Onkologische Praxis Eppendorf (HOPE)
Hamburg, 20249
- Recruiting
Asklepios Kliniken Hamburg GmbH
Hamburg, 22453
- Recruiting
Asklepios Tumorzentrum Hamburg, Asklepios Klinik Altona
Hamburg, 22763
- Recruiting
Medizinische Hochschule Hannover (MHH)
Hanover, Lower Saxony, 30625
- Recruiting
Medizinische Hochschule Hannover (MHH)
Hanover, 30625
- Terminated
Universitätsklinikum Leipzig
Leipzig, Saxony, 04103
- Recruiting
LMU Klinikum - Campus Großhadern
München, Bavaria, D-81377
- Recruiting
Klinikum rechts der Isar der Technischen Universitaet Muenchen
München, 81675
- Recruiting
CCC Muenchen TUM
Munich, Bavaria, D-81675
- Recruiting
Universitaetsklinikum Ulm
Ulm, 89081
United Kingdom12 sites, 12 recruiting
- Recruiting
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, BS2 8ED
- Recruiting
Cambridge University Hospitals NHS Foundation Trust, Oncology Centre
Cambridge, CB2 0QQ
- Recruiting
NHS Greater Glasgow & Clyde - Beatson West of Scotland Cancer Care
Glasgow, Glasgow CITY, G12 0YN
- Recruiting
Leeds Teaching Hospitals NHS Trust, st James's Institute of Oncology
Leeds, LS97TF
- Recruiting
Guy's and Saint Thomas' NHS Foundation Trust
London, SE1 9RT
- Recruiting
The Royal Marsden Hospital - Chelsea Site
London, SW3 6JJ
- Recruiting
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ
- Recruiting
Imperial College Healthcare NHS Trust
London, W12 0NN
- Recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BX
- Recruiting
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, Chelsea, NE7 7DN
- Recruiting
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, NE7 7DN
- Recruiting
The Royal Marsden Hospital
Sutton, Surrey, SM2 5PT
Poland11 sites, 11 recruiting
- Recruiting
Apteka Szpitalna Uniwersytie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, 80-214
- Recruiting
Klinika Onkologii i Radioterapii Uniwersyteckie Centrum Kliniczne.
Gdansk, Pomeranian Voivodeship, 80-214
- Recruiting
Przychodnia Lekarska KOMED Roman Karaszewski
Konin, Greater Poland Voivodeship, 62-500
- Recruiting
Salve Medica Apteka Szpitalna
Lodz, 91-211
- Recruiting
Salve Medica
Lodz, 91-211
- Not yet recruiting
MRUK-MED | Sp. z.o.o Apteka szpitalna
Rzeszów, Podkarpackie Voivodeship, 35-021
- Not yet recruiting
MRUK-MED | Sp. z.o.o
Rzeszów, Podkarpackie Voivodeship, 35-021
- Recruiting
Narodowy lnstytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy lnstytut Badawczy
Warsaw, Masovian Voivodeship, 02-034
- Recruiting
Marii Sklodowskiej-Curie Panstwowy lnstytut Badawczy
Warsaw, Masovian Voivodeship, 02-781
- Not yet recruiting
Wojskowy Instytut Medyczny Klinika Onkologii
Warsaw, Masovian Voivodeship, 04-141
- Not yet recruiting
Wojskowy Instytut Medyczny
Warsaw, Masovian Voivodeship, 04-141
Brazil10 sites, 10 recruiting
- Recruiting
Instituto De Educação, Pesquisa e Gestão em Saúde - Instituto Américas
Barra da Tijuca, Rio de Janeiro, 22.775-001
- Recruiting
Hospital de Cancer de Barretos/Fundacao Pio XII
Barretos, São Paulo, 14784-400
- Recruiting
CIONC-Centro Integrado de Oncologia de Curitiba
Curitiba, Paraná, 80810-050
- Recruiting
Centro de Pesquisas Clinicas da Fundação Doutor Amaral Carvalho
Jaú, São Paulo, 17210-120
- Recruiting
Centro Integrado de Pesquisa em Oncologia CIPO-GHC / Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, 91350-200
- Recruiting
Institute de Educacao, Pesquisa e Gestao em Saude - Instituto COI
Rio de Janeiro, Rio de Janeiro, 22775-001
- Recruiting
Institute de Educacao, Pesquisa e Gestao em Saude - Instituto COI
Rio de Janeiro, Rio de Janeiro, 22793-080
- Recruiting
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia.
Santo André, São Paulo, 09060-650
- Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, CEP 15090-000
- Recruiting
ICESP - Instituto do Câncer do Estado de São Paulo Octavio Frias de Oliveira.
São Paulo, 01245-000
Belgium8 sites, 8 recruiting
- Recruiting
Institut Jules Bordet
Anderlecht, 1070
- Recruiting
Cliniques Universitaires Saint-Luc
Brussels, 1200
- Recruiting
UZA
Edegem, 2650
- Recruiting
CHU HELORA - Hopital de Jolimont
Haine-Saint-Paul, 7100
- Not yet recruiting
Universitair Ziekenhuis Leuven
Leuven, 3000
- Recruiting
Centre Hospitalier Chretien - Clinique MontLegia
Liège, 4000
- Recruiting
Maag-,Darm- en Leverziekten AZ Turnhout
Turnhout, 2300
- Recruiting
Oncologisch Dagziekenhuis AZ Turnhout Campus Sint-Elisabeth
Turnhout, 2300
Ireland7 sites, 7 recruiting
- Recruiting
Cork University Hospital,Department of Medical Onncology
Cork, T12 DC4A
- Recruiting
Bon Secours Hospital
Cork, T12 DV56
- Recruiting
St Vincents University Hospital
Dublin, D04 T6F4
- Recruiting
Mater Misericordiae University Hospital
Dublin, D07 R2WY
- Recruiting
Mater Private Hospital
Dublin, D07 WKW8
- Recruiting
Beaumont Hospital
Dublin, D09 V2N0
- Recruiting
University Hospital Waterford
Waterford, X91 ER8E
South Korea7 sites, 7 recruiting
- Recruiting
Gachon University Gil Medical Center
Incheon, 21565
- Recruiting
Korea University Anam Hospital
Seoul, 02841
- Recruiting
Seoul National University Hospital
Seoul, 03080
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
- Recruiting
Asan Medical Center
Seoul, 05505
- Recruiting
Samsung Medical Center
Seoul, 06351
- Recruiting
Korea University Guro Hospital
Seoul, 08308
Argentina6 sites, 6 recruiting
- Recruiting
Instituto Medico Especializado Alexander Fleming
Buenos Aires, 1426
- Recruiting
Hospital Britanico de Buenos Aires
CABA, 1280
- Recruiting
IONC Instituto Oncologico de Cordoba Fundacion Richardet Longo
Córdoba, X5001 HWE
- Recruiting
CEMAIC - Centro Medico Privado
Córdoba
- Recruiting
Centro de Investigacion Pergamino SA
Pergamino, Buenos Aires, 2700
- Recruiting
Instituto Medico de la Fundacion Estudios Clinicos
Rosario, Santa Fe Province, S2000DEJ
Taiwan6 sites, 6 recruiting
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833, (R.O.C.)
- Recruiting
National Cheng Kung University Hospital
Tainan, 704, R.O.C.
- Recruiting
National Taiwan University Hospital
Taipei, 100 ROC
- Recruiting
National Taiwan University Hospital Clinical Trial Pharmacy
Taipei, 10048
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
- Recruiting
Chang Gung Memorial Hospital LinKou
Taoyuan, 333 (R.O.C.)
Austria5 sites, 5 recruiting
- Recruiting
Uniklinikum Salzburg, Landeskrankenhaus
Salzburg, 5020
- Not yet recruiting
AKH - Medizinische Universitat Wien
Vienna, 1090
- Recruiting
Klinikum Wels-Grieskirchen GmbH Austria
Wels, Upper Austria, A-4600
- Recruiting
Klinikum Wels-Grieskirchen GmbH Austria
Wels, 4600
- Not yet recruiting
Landesklinikum Wiener Neustadt
Wiener Neustadt, 2700
Canada5 sites, 5 recruiting
- Recruiting
Jewish General Hospital
Montreal, Quebec, H3T 1E2
- Recruiting
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6
- Recruiting
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
- Recruiting
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5
- Recruiting
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Greece5 sites, 5 recruiting
- Recruiting
Athens Medical Center - Psychikon branch
Athens, Attikí, 11525
- Not yet recruiting
University General Hospital "Attikon"
Athens, Chaidari, 124 62
- Recruiting
Evgenidion Clinic Agia Trias Oncology Department
Athens, 11528
- Not yet recruiting
"University General Hospital of Heraklion Oncology Unit "
Heraklion, Crete, 71500
- Recruiting
"Papageorgiou" General Hospital of Thessaloniki 2nd Internal Medicine/Oncology Clinic of Aristotle
Nea Efkarpia, Thessaloniki, 56403
Netherlands4 sites, 4 recruiting
- Recruiting
Netherlands Cancer Institute
Amsterdam, 1066 CX
- Recruiting
Klinische Farmacie
Nieuwegein, 3534 CM
- Recruiting
St. Antonius Ziekenhuis - Ziekenhuis Utrecht
Utrecht, 3543 AZ
- Recruiting
Viecuri Medisch Centrum
Venlo, 5912 BL
Portugal4 sites, 4 recruiting
- Recruiting
Hospital Garcia de Orta
Almada, 2805-267
- Recruiting
Unidade Local de Saude da Guarda-Hospital Sousa Martins
Guarda, 6300-035
- Recruiting
Fundacao Champalimaud
Lisbon, 1400-038
- Recruiting
Centro Hospitalar Universitário de Santo Antonio,E.P.E.
Porto, 4099-001
Australia3 sites, 3 recruiting
- Not yet recruiting
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050
- Recruiting
St Vincent's Hospital
Fitzroy, Victoria, 3065
- Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Chile3 sites, 3 recruiting
- Recruiting
Biocenter
Concepción
- Recruiting
Centro de estudios clinicos SAGA
Santiago
- Recruiting
Oncocentro Apys
Viña del Mar, Valparaiso
Norway3 sites, 3 recruiting
- Recruiting
Sjukehusapoteket i Bergen [Bergen Hospital Pharmacy]
Bergen, N0-5053
- Recruiting
Helse Bergen HF, Haukeland University Hospital
Bergen, NO-5021
- Recruiting
Oslo University Hospital (OUH) - The Norwegian Radium Hospital
Oslo, 0379
Slovakia2 sites, 2 recruiting
- Recruiting
Narodny Onkologicky ustav II.Onkologicka Klinika LFUK a NOU
Bratislava, 833 10
- Recruiting
Narodny onkologicky ustav nemocnica lekaren
Bratislava, 833 10
Switzerland2 sites, 2 recruiting
- Recruiting
Zuripharm AG
Schlieren, 8952
- Recruiting
Universitatsspital Zurich - Klinik fur Medizinische Onkologie und Hamatologie USZ
Zurich, 8091
About this study
Official title: An Open-label Randomized Phase 3 Study of Tucatinib in Combination With Trastuzumab and mFOLFOX6 Versus mFOLFOX6 Given With or Without Either Cetuximab or Bevacizumab as First-line Treatment for Subjects With HER2+ Metastatic Colorectal Cancer
This study is being done to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also determine what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease.
Participants in this study have colorectal cancer that has spread through the body (metastatic) and/or cannot be removed with surgery (unresectable).
Read more
Participants will be assigned randomly to the tucatinib group or standard of care group. The tucatinib group will get tucatinib, trastuzumab, and mFOLFOX6. The standard of care group will get either:
- mFOLFOX6 alone,
- mFOLFOX6 with bevacizumab, or
- mFOLFOX6 with cetuximab mFOLFOX6 is a combination of multiple drugs. All of the drugs given in this study are used to treat this type of cancer.
- Conditions
- Colorectal Neoplasms
- Being tested
- tucatinib, trastuzumab, bevacizumab, cetuximab, oxaliplatin
- Keywords
- Colorectal Cancer, CRC, Seattle Genetics
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tucatinibDrug
Also called TUKYSA, ONT-380, ARRY-380, PF-07265792
300mg given by mouth (orally) twice daily
trastuzumabDrug
Also called Herceptin
8mg/kg loading dose will be given into the vein (IV; intravenously) on Cycle 1 day 1, followed by 6mg/kg given by IV every 3 weeks thereafter.
bevacizumabDrug
Also called Avastin
5mg/kg given by IV every 2 weeks
cetuximabDrug
Also called Erbitux
400mg/m2 loading dose will be given by IV on Cycle 1 day 1, followed by 250mg/m2 given by IV weekly
oxaliplatinDrug
85mg/m2 given by IV every 2 weeks. Component of mFOLFOX6.
leucovorinDrug
400mg/ m2 given by IV every 2 weeks. Component of mFOLFOX6.
levoleucovorinDrug
200mg/ m2 given by IV every 2 weeks. May be given in place of leucovorin. Component of mFOLFOX6.
fluorouracilDrug
400mg/m2 given by IV bolus then 2400mg/m2 given by continuous IV infusion (over 46-48 hours) every 2 weeks. Component of mFOLFOX6.
| Study group | Role | What they receive |
|---|---|---|
| Tucatinib Arm | Experimental | Tucatinib + trastuzumab + mFOLFOX6 Receives: Drug: tucatinib; Drug: trastuzumab; Drug: oxaliplatin; Drug: leucovorin; Drug: levoleucovorin; Drug: fluorouracil |
| Standard of Care Arm | Active comparator | Either (1) mFOLFOX6, (2) mFOLFOX6 and bevacizumab, or (3) mFOLFOX6 and cetuximab Receives: Drug: bevacizumab; Drug: cetuximab; Drug: oxaliplatin; Drug: leucovorin; Drug: levoleucovorin; Drug: fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by Blinded Independent Central Review (BICR)
The time from the date of randomization to the BICR assessment of disease progression according to RECIST v1.1 or death from any cause
Measured: Up to approximately 3 years
Secondary outcomes (12)
Overall survival (OS)
The time from randomization to death from any cause
Measured: Up to approximately 6 years
Confirmed objective response rate (cORR) per RECIST v1.1 by BICR
The proportion of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1, as assessed by BICR
Measured: Up to approximately 3 years
PFS per RECIST v1.1 by investigator assessment
The time from the date of randomization to the investigator assessment of disease progression according to RECIST v1.1 or death from any cause
Measured: Up to approximately 3 years
cORR per RECIST v1.1 by investigator assessment
The proportion of participants with confirmed CR or PR according to RECIST v1.1, as assessed by investigators
Measured: Up to approximately 3 years
Duration of response (DOR) per RECIST v1.1 by BICR
The time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of disease progression per RECIST v1.1 or death from any cause
Measured: Up to approximately 3 years
DOR per RECIST v1.1 by investigator assessment
The time from first documentation of objective response (CR or PR that is subsequently confirmed) to the first documentation of disease progression per RECIST v1.1 or death from any cause
Measured: Up to approximately 3 years
Time to second progression or death (PFS2)
The time from randomization to disease progression on the next-line of therapy, or death from any cause
Measured: Up to approximately 3 years
Incidence of adverse events (AEs)
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Measured: Through 30 days after the last study treatment; approximately 1 year
Incidence of dose alterations
Measured: Through 30 days after the last study treatment; approximately 1 year
Trough concentration (Ctrough)
PK parameter
Measured: Approximately 4 months
Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQC30) score
Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores. Scale scores range from 0-100. For functioning and global health status/quality of life (QoL) scales, higher scores indicate better functioning or global health status/quality of life (QoL). For symptom scales, higher scores indicate greater symptom burden.
Measured: Through 30-37 days after the last study treatment; approximately 1 year
Time to meaningful change in EORTC QLQ30 score
The time from baseline to the first onset of a ≥10-point changes in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores. Scale scores range from 0-100.
For functioning and global health status/QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden.
Measured: Through 30-37 days after the last study treatment; approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start24 Oct 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion3 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Seagen, a wholly owned subsidiary of PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seagen, a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05253651
- Sponsor's protocol ID
- SGNTUC-029
- Other IDs
- C4251008, 2024-514180-25-00
- Acronym
- MOUNTAINEER-03
- Status last verified
- Jul 2026
- First submitted
- 14 Feb 2022
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Strickler JH, Bekaii-Saab T, Cercek A, Heinemann V, Nakamura Y, Raghav K, Siena S, Tabernero J, Van Cutsem E, Yoshino T, Ramos J, Guan X, Andre T. MOUNTAINEER-03 phase III study design: first-line mFOLFOX6 + tucatinib + trastuzumab for HER2+ metastatic colorectal cancer. Future Oncol. 2025 Feb;21(3):303-311. doi: 10.1080/14796694.2024.2441101. Epub 2024 Dec 26.
PubMed 39723627