AzTrials
AzTrials

Breast NeoplasmsPhase 3NCT07060807

A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)

A Phase 3 study testing Patritumab deruxtecan, Paclitaxel and Nab-paclitaxel in people with Breast Neoplasms, run by Merck Sharp & Dohme LLC at 205 sites in 26 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

Researchers are looking for other ways to treat breast cancer (BC) that is hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) and either unresectable locally advanced or metastatic. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Neoplasms
What is being tested?
Patritumab deruxtecan, Paclitaxel and Nab-paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
205 sitesin 26 countries
Study dates
21 Jul 2025to 14 Jul 2033
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

  • The main inclusion criteria include but are not limited to the following:
  • Has a diagnosis of hormone receptor positive (HR+)/human epidermal growth factor receptor 2 (HER2)- invasive breast carcinoma that is either locally advanced disease not amenable to resection with curative intent (herein called unresectable) or metastatic disease not treatable with curative intent
  • Has centrally-confirmed HR+ and HER2- results and human epidermal growth factor receptor 3 (HER3) evaluable results from a biopsy obtained from a distant metastatic site or a locally advanced lesion on or after the time of diagnosis of locally advanced unresectable or metastatic breast cancer. A new biopsy obtained after progression of the most recent line of therapy is preferred
  • Must have had progression or recurrence on prior cyclin-dependent kinase (CDK)4/6 inhibitor + endocrine therapy (ET) with one of the following:
  • Radiographic disease progression, as assessed by the investigator, on CDK4/6 inhibitor + ET as 1L for treatment of unresectable locally advanced or metastatic HR+/HER2- breast cancer. CDK4/6 inhibitor + ET must be the only line of therapy received in the advanced setting, or
  • Disease recurrence, either radiographic and/or confirmed histologically via biopsy as assessed by the investigator, while on adjuvant ET in combination with a CDK4/6 inhibitor OR within 24 months from the date of last dose of adjuvant CDK4/6 inhibitor
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  • Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology
  • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
  • Has an Eastern Cooperative Oncology Group performance status of 0 or 1 assessed within 7 days before randomization

Who cannot join

  • The main exclusion criteria include but are not limited to the following:
  • Has breast cancer amenable to treatment with curative intent
  • Is eligible to receive additional endocrine-based treatment in the advanced setting as determined by the investigator
  • Has a known germline breast cancer gene (BRCA) mutation (deleterious or suspected deleterious) where poly (ADP-ribose) polymerase (PARP) inhibitor(s) is a potential treatment option
  • Has current visceral crisis or is at risk for impending visceral crisis that has or may cause imminent organ compromise and/or other life-threatening complications
  • Has any of the following: a pulse oximeter reading <92% at rest, or requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
Show all 18Show fewer
  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
  • Has ≥Grade 2 peripheral neuropathy.
  • Has clinically significant corneal disease
  • Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer
  • Has received prior treatment with an anti-HER3 antibody and/or antibody-drug conjugate that consists of a topoisomerase I inhibitor (eg, T-DXd) or any other topoisomerase I inhibitor therapy
  • Has received prior systemic anticancer therapy within 4 weeks (or 5 half-lives, whichever is shorter) before randomization; participants previously treated with ET plus a CDK4/6 inhibitor may participate as long as at least 2 weeks have elapsed since the last dose of therapy was administered
  • Has received prior radiotherapy for non-central nervous system disease, or required corticosteroids for radiation-related toxicities, within 14 days of the first dose of study intervention
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
  • Has known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has history of (noninfectious) interstitial lung disease (ILD) or pneumonitis irrespective of steroid use, or has current ILD or suspected ILD, or ILD that cannot be ruled out by imaging at Screening
  • Has severe hypersensitivity (≥Grade 3) to HER3-DXd and/or any of its excipients
  • Has severe hypersensitivity (≥Grade 3) to all the available TPC and/or any of their excipients

Trial locations and contacts

205 sites in 26 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

205 sites in 26 countries

United States35 sites, 35 recruiting

  • Presbyterian Kaseman Hospital ( Site 0072)

    Albuquerque, New Mexico, 87110

    Study Coordinator, 505-925-0405

    Recruiting

  • University of New Mexico Comprehensive Cancer Center ( Site 0047)

    Albuquerque, New Mexico, 87131

    Study Coordinator, 505-272-4946

    Recruiting

  • AdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0024)

    Altamonte Springs, Florida, 32701

    Study Coordinator, 407-834-5151

    Recruiting

  • Novant Health Cancer Institute ( Site 0019)

    Charlotte, North Carolina, 28204

    Study Coordinator, 980-302-6500

    Recruiting

  • TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0020)

    Cincinnati, Ohio, 45220

    Study Coordinator, 513-865-9460

    Recruiting

  • Texas Oncology - DFW ( Site 8003)

    Dallas, Texas, 75246

    Study Coordinator, 214-370-1794

    Recruiting

  • Southern Cancer Center (SCC) ( Site 8000)

    Daphne, Alabama, 36526

    Study Coordinator, 251-607-5283

    Recruiting

  • JPS Health Network ( Site 0067)

    Fort Worth, Texas, 76104

    Study Coordinator, 817-702-8049

    Recruiting

  • St. Marys Hospital and Regional Medical Center-SCL Health Cancer Centers of Colorado ( Site 0021)

    Grand Junction, Colorado, 81501

    Study Coordinator, 970-298-7638

    Recruiting

  • John Theurer Cancer Center at Hackensack University Medical Center ( Site 0001)

    Hackensack, New Jersey, 07601

    Study Coordinator, 551-996-5900

    Recruiting

  • Texas Oncology - Gulf Coast ( Site 8006)

    Houston, Texas, 77024

    Study Coordinator, 713-467-1722

    Recruiting

  • Oncology Consultants P.A. ( Site 0061)

    Houston, Texas, 77030

    Study Coordinator, 713-516-4968

    Recruiting

  • Queens Hospital Cancer Center ( Site 0011)

    Jamaica, New York, 11432

    Study Coordinator, 718-883-4133

    Recruiting

  • Baptist Health Lexington ( Site 0050)

    Lexington, Kentucky, 40503

    Study Coordinator, 859-509-3044

    Recruiting

  • Baptist Health Hamburg ( Site 0071)

    Lexington, Kentucky, 40509

    Study Coordinator, 859-639-7827

    Recruiting

  • Los Angeles Hematology Oncology Medical Group ( Site 0026)

    Los Angeles, California, 90017

    Study Coordinator, 626-627-6666

    Recruiting

  • Circuit Clinical/SSM Health Dean Medical Group ( Site 0039)

    Madison, Wisconsin, 53715

    Study Coordinator, 608-355-2033

    Recruiting

  • Texas Oncology - Central/South Texas ( Site 8005)

    McAllen, Texas, 78503

    Study Coordinator, 956-687-5150

    Recruiting

  • SCRI Oncology Partners ( Site 7000)

    Nashville, Tennessee, 37203

    Study Coordinator, 615-329-7274

    Recruiting

  • Tennessee Oncology ( Site 0068)

    Nashville, Tennessee, 37203

    Study Coordinator, 615-320-5090

    Recruiting

  • Rutgers Cancer Institute of New Jersey ( Site 0033)

    New Brunswick, New Jersey, 08903

    Study Coordinator, 732-235-2465

    Recruiting

  • Medical Oncology Hematology Consultants (MOHC) ( Site 8002)

    Newark, Delaware, 19713

    Study Coordinator, 302-366-1200

    Recruiting

  • Hoag Memorial Hospital Presbyterian ( Site 0025)

    Newport Beach, California, 92663

    Study Coordinator, 949-764-5501

    Recruiting

  • Virginia Oncology Associates (VOA) ( Site 8001)

    Norfolk, Virginia, 23502

    Study Coordinator, 757-368-5033

    Recruiting

  • University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0058)

    Pittsburgh, Pennsylvania, 15213

    Study Coordinator, 412-641-6500

    Recruiting

  • Cancer Care Specialists ( Site 9503)

    Reno, Nevada, 89511

    Study Coordinator, 775-329-0222x230

    Recruiting

  • Presbyterian Rust Jorgensen Cancer ( Site 0073)

    Rio Rancho, New Mexico, 87124

    Study Coordinator, 505-253-7878

    Recruiting

  • Mays Cancer Center ( Site 0049)

    San Antonio, Texas, 78229

    Study Coordinator, 210-450-3838

    Recruiting

  • Comprehensive Hematology Oncology ( Site 0060)

    St. Petersburg, Florida, 33709

    Study Coordinator, 727-344-6569

    Recruiting

  • Northwest Medical Specialties, PLLC ( Site 0062)

    Tacoma, Washington, 98405

    Study Coordinator, 253-841-4296

    Recruiting

  • The University of Arizona Cancer Center - North Campus ( Site 0055)

    Tucson, Arizona, 85719

    Study Coordinator, 520-626-0191

    Recruiting

  • Optum Medical Care, PC ( Site 0009)

    Westbury, New York, 11590

    Study Coordinator, 516-488-2918

    Recruiting

  • Shenandoah Oncology ( Site 8004)

    Winchester, Virginia, 22601

    Study Coordinator, 540-662-1108

    Recruiting

  • Novant Health Oncology Specialists ( Site 0074)

    Winston-Salem, North Carolina, 27103

    Study Coordinator, 336-277-8800

    Recruiting

  • Cancer Care Associates Of York ( Site 0063)

    York, Pennsylvania, 17403

    Study Coordinator, 717-741-9229

    Recruiting

Other trials in United States

China24 sites, 23 recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences ( Site 3100)

    Beijing, Beijing Municipality, 100021

    Active, not recruiting

  • Peking University People's Hospital ( Site 3138)

    Beijing, Beijing Municipality, 100044

    Study Coordinator, 010-88326666

    Recruiting

  • Jilin Cancer Hospital ( Site 3116)

    Changchun, Jilin, 132000

    Study Coordinator, 0431-80596065

    Recruiting

  • Hunan Cancer Hospital ( Site 3134)

    Changsha, Hunan, 410013

    Study Coordinator, 0731-89762160

    Recruiting

  • Sichuan Cancer Hospital. ( Site 3110)

    Chengdu, Sichuan, 610041

    Study Coordinator, 02885420509

    Recruiting

  • West China Hospital of Sichuan University ( Site 3139)

    Chengdu, Sichuan, 610041

    Study Coordinator, 028-85422114

    Recruiting

  • The First Affiliated Hospital of Chongqing Medical University ( Site 3101)

    Chongqing, Chongqing Municipality, 400016

    Study Coordinator, 02389011515

    Recruiting

  • The First Affiliated hospital of Xiamen University ( Site 3120)

    Fujian, Fujian, 361003

    Study Coordinator, 0592-2137327

    Recruiting

  • Sun Yat-Sen University Cancer Center ( Site 3102)

    Guangzhou, Guangdong, 510060

    Study Coordinator, 020-87342479

    Recruiting

  • Sir Run Run Shaw Hospital ( Site 3117)

    Hangzhou, Zhejiang, 310016

    Study Coordinator, +8657186960497

    Recruiting

  • Zhejiang Cancer Hospital ( Site 3109)

    Hangzhou, Zhejiang, 310022

    Study Coordinator, 0571-88122072

    Recruiting

  • Anhui Provincial Cancer Hospital ( Site 3140)

    Hefei, Anhui, 230088

    Study Coordinator, 0551-65327666

    Recruiting

  • Jiangmen Central Hospital ( Site 3132)

    Jiangmen, Guangdong, 529000

    Study Coordinator, 0750-3989521

    Recruiting

  • Affiliated Cancer Hospital of Shandong First Medical University ( Site 3115)

    Jinan, Shandong, 250117

    Study Coordinator, 0531-67626073

    Recruiting

  • Taizhou Hospital of Zhejiang Province ( Site 3137)

    Linhai, Zhejiang, 317000

    Study Coordinator, +86 0516 85120120

    Recruiting

  • Nanchang People's Hospital ( Site 3124)

    Nanchang, Jiangxi, 330008

    Study Coordinator, 0791-86728121

    Recruiting

  • Jiangsu Cancer Hospital ( Site 3107)

    Nanjing, Jiangsu, 210009

    Study Coordinator, +8602583283415

    Recruiting

  • Jiangsu Province Hospital ( Site 3105)

    Nanjing, Jiangsu, 210029

    Study Coordinator, 02568308145

    Recruiting

  • Guangxi Medical University Affiliated Tumor Hospital ( Site 3118)

    Nanning, Guangxi, 530021

    Study Coordinator, 0771-5331955

    Recruiting

  • Xinjiang Medical University Cancer Hospital - Urumqi ( Site 3112)

    Ürümqi, Xinjiang, 830000

    Study Coordinator, +8609917819133

    Recruiting

  • Chongqing Three Gorges Central Hospital's ( Site 3128)

    Wanzhou, Chongqing Municipality, 404000

    Study Coordinator, 02358103238

    Recruiting

  • Xi'an International Medical Center Hospital ( Site 3122)

    Xi'an, Shaanxi, 710100

    Study Coordinator, 02968302436

    Recruiting

  • Xiangyang Central Hospital ( Site 3123)

    Xiangyang, Hubei, 441106

    Study Coordinator, +8607102810910

    Recruiting

  • Henan Cancer Hospital ( Site 3108)

    Zhengzhou, Henan, 450008

    Study Coordinator, 0371-65588007

    Recruiting

Other trials in China

Japan20 sites, 20 recruiting

  • Akita University Hospital ( Site 3207)

    Akita, 010-8543

    Study Coordinator, +81-18-834-1111

    Recruiting

  • Chiba Cancer Center ( Site 3203)

    Chiba, 260-8717

    Study Coordinator, +81-43-264-5431

    Recruiting

  • National Cancer Center Hospital ( Site 3206)

    Chūō, Tokyo, 104-0045

    Study Coordinator, +81-3-3542-2511

    Recruiting

  • National Hospital Organization Kyushu Cancer Center ( Site 3208)

    Fukuoka, 811-1395

    Study Coordinator, +81-92-541-3231

    Recruiting

  • Fukushima Medical University Hospital ( Site 3212)

    Fukushima, 960-1295

    Study Coordinator, +81-24-547-1111

    Recruiting

  • Saitama Medical University International Medical Center ( Site 3220)

    Hidaka, Saitama, 350-1298

    Study Coordinator, +81-42-984-4111

    Recruiting

  • Kansai Medical University Hospital ( Site 3213)

    Hirakata, Osaka, 573-1191

    Study Coordinator, +81-72-804-0101

    Recruiting

  • Hiroshima City Hiroshima Citizens Hospital ( Site 3214)

    Hiroshima, 730-8518

    Study Coordinator, +81-82-221-2291

    Recruiting

  • Social medical corporation Hakuaikai Sagara Hospital ( Site 3219)

    Kagoshima, 892-0833

    Study Coordinator, +81-99-224-1800

    Recruiting

  • National Hospital Organization Shikoku Cancer Center ( Site 3218)

    Matsuyama, Ehime, 791-0280

    Study Coordinator, +81-89-999-1111

    Recruiting

  • Toranomon Hospital ( Site 3205)

    Minato, Tokyo, 105-8470

    Study Coordinator, +81-3-3588-1111

    Recruiting

  • Aichi Cancer Center ( Site 3200)

    Nagoya, Aichi-ken, 464-8681

    Study Coordinator, +81-52-762-6111

    Recruiting

  • Nagoya City University Hospital ( Site 3210)

    Nagoya, Aichi-ken, 467-8602

    Study Coordinator, +81-52-858-7215

    Recruiting

  • Okayama University Hospital ( Site 3217)

    Okayama, 700-8558

    Study Coordinator, +81-86-223-7151

    Recruiting

  • National Hospital Organization Osaka National Hospital ( Site 3201)

    Osaka, 540-0006

    Study Coordinator, +81-6-6942-1331

    Recruiting

  • Kindai University Hospital ( Site 3204)

    Sakai, Osaka, 590-0197

    Study Coordinator, +81-72-366-0221

    Recruiting

  • National Hospital Organization Hokkaido Cancer Center ( Site 3215)

    Sapporo, Hokkaido, 003-0804

    Study Coordinator, +81-11-811-9111

    Recruiting

  • Showa Medical University Hospital ( Site 3209)

    Shinagawa, Tokyo, 142-8666

    Study Coordinator, +81-3-3784-8000

    Recruiting

  • Shizuoka Cancer Center ( Site 3202)

    Sunto-gun, Shizuoka, 411-8777

    Study Coordinator, +81-55-989-5222

    Recruiting

  • Mie University Hospital ( Site 3216)

    Tsu, Mie-ken, 514-8507

    Study Coordinator, +81-59-231-5246

    Recruiting

Other trials in Japan

Turkey (Türkiye)11 sites, 10 recruiting

  • Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 2107)

    Adana, 01120

    Study Coordinator, +905353067506

    Recruiting

  • Adana Medical Park Seyhan Hastanesi ( Site 2110)

    Adana, 1140

    Study Coordinator, +905459001670

    Recruiting

  • Hacettepe Universite Hastaneleri ( Site 2100)

    Ankara, 06230

    Study Coordinator, +903123052935

    Recruiting

  • Memorial Ankara Hastanesi ( Site 2106)

    Ankara, 06520

    Study Coordinator, +903122536622

    Recruiting

  • Gazi University Health Research and Application Center Gazi Hospital ( Site 2101)

    Ankara, 06560

    Study Coordinator, +90 312 202 44 44

    Recruiting

  • Ankara Bilkent Şehir Hastanesi ( Site 2105)

    Ankara, 6800

    Completed

  • Dicle Üniversitesi ( Site 2102)

    Diyarbakır, 21280

    Study Coordinator, +90 412 248 80 01

    Recruiting

  • Koç Üniversitesi Hastanesi ( Site 2104)

    Istanbul, 34010

    Study Coordinator, 08502508250

    Recruiting

  • Mersin Sehir Eğitim ve Araştırma Hastanesi ( Site 2103)

    Mersin, 33240

    Study Coordinator, +903247517411

    Recruiting

  • Recep Tayyip Erdogan University Training and Research Hospital ( Site 2108)

    Rize, 53020

    Study Coordinator, +905069939926

    Recruiting

  • Samsun Medical Park Hastanesi ( Site 2109)

    Samsun, 55200

    Study Coordinator, +90 362 311 40 40

    Recruiting

Other trials in Turkey (Türkiye)

Argentina7 sites, 7 recruiting

  • Fundación Respirar ( Site 0201)

    Buenos Aires, Buenos Aires F.D., C1426AAL

    Study Coordinator, +541170781548

    Recruiting

  • Instituto Alexander Fleming ( Site 0202)

    CABA, C1426DRB

    Study Coordinator, +541132218900

    Recruiting

  • Hospital Aleman ( Site 0200)

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1118AAT

    Study Coordinator, +541148277000X2306

    Recruiting

  • Hospital Italiano de Córdoba ( Site 0206)

    Córdoba, X5004BAL

    Study Coordinator, +543514106500

    Recruiting

  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0205)

    Mar del Plata, Buenos Aires, B7600FZO

    Study Coordinator, +542234963224

    Recruiting

  • Centro Privado de RMI Rio Cuarto ( Site 0207)

    Río Cuarto, Córdoba Province, X5800ALB

    Study Coordinator, +543584620273

    Recruiting

  • Instituto de Oncología de Rosario ( Site 0208)

    Rosario, Santa Fe Province, S2000KZE

    Study Coordinator, +543414218909

    Recruiting

Other trials in Argentina

Poland7 sites, 7 recruiting

  • Bialostockie Centrum Onkologii ( Site 1604)

    Bialystok, Podlaskie Voivodeship, 15-027

    Study Coordinator, +48856646888

    Recruiting

  • Centrum Onkologii im prof Franciszka Lukaszczyka ( Site 1618)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

    Study Coordinator, +48523743344

    Recruiting

  • Szpital Wojewodzki im.M.Kopernika. ( Site 1607)

    Koszalin, West Pomeranian Voivodeship, 75-581

    Study Coordinator, +48943488400

    Recruiting

  • Salve Medica sp. z o.o. sp. k. ( Site 1615)

    Lodz, Łódź Voivodeship, 91-211

    Study Coordinator, +48422546440

    Recruiting

  • Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko-Mazurskim Centrum Onko ( Site 1614)

    Olsztyn, Warmian-Masurian Voivodeship, 10-228

    Study Coordinator, 48895398610

    Recruiting

  • Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku-Oncologii, Chemioterapii ( Site 1616)

    Słupsk, Pomeranian Voivodeship, 76-200

    Study Coordinator, +48598460390

    Recruiting

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 1600)

    Warsaw, Masovian Voivodeship, 02-781

    Study Coordinator, +48225462522

    Recruiting

Other trials in Poland

Spain7 sites, 7 recruiting

  • CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 1820)

    A Coruña, La Coruna, 15006

    Study Coordinator, +34981178000

    Recruiting

  • Institut Català d'Oncologia (ICO) - Badalona ( Site 1823)

    Badalona, Barcelona, 08916

    Study Coordinator, +34934978925

    Recruiting

  • Hospital Clinic de Barcelona ( Site 1821)

    Barcelona, 08036

    Study Coordinator, +34932275400

    Recruiting

  • Hospital Universitario Ramon y Cajal ( Site 1824)

    Madrid, 28034

    Study Coordinator, 913368263

    Recruiting

  • Hospital Clinico San Carlos... ( Site 1822)

    Madrid, 28040

    Study Coordinator, +34913303000 484816

    Recruiting

  • Hospital Universitario Marques de Valdecilla ( Site 1825)

    Santander, Cantabria, 39008

    Study Coordinator, 942212100 ext 73351

    Recruiting

  • Hospital Universitario Virgen de Valme ( Site 1826)

    Seville, 41014

    Study Coordinator, 955015273

    Recruiting

Other trials in Spain

Taiwan7 sites, 7 recruiting

  • Ditmanson Medical Foundation Chia-Yi Christian Hospital ( Site 2806)

    Chiayi City, Chiayi, 600

    Study Coordinator, +88652765041x3190

    Recruiting

  • Taichung Veterans General Hospital ( Site 2803)

    Taichung, 407

    Study Coordinator, +886423592525x5031

    Recruiting

  • National Cheng Kung University Hospital ( Site 2804)

    Tainan, 704302

    Study Coordinator, +88662353535x6729

    Recruiting

  • Chi-Mei Medical Center ( Site 2805)

    Tainan, 710

    Study Coordinator, +88662812811x53571

    Recruiting

  • National Taiwan University Hospital ( Site 2800)

    Taipei, 10048

    Study Coordinator, +886905051082

    Recruiting

  • MacKay Memorial Hospital ( Site 2802)

    Taipei, 10449

    Study Coordinator, +886975835311

    Recruiting

  • National Taiwan University Cancer Center (NTUCC) ( Site 2801)

    Taipei, 106

    Study Coordinator, +886905051082

    Recruiting

Other trials in Taiwan

Brazil6 sites, 6 recruiting

  • ANIMI - Unidade de Tratamento Oncologico ( Site 0306)

    Lages, Santa Catarina, 88501-001

    Study Coordinator, +554933805220

    Recruiting

  • Liga Norte Riograndense Contra o Câncer ( Site 0301)

    Natal, Rio Grande do Norte, 59062-000

    Study Coordinator, +558440095595

    Recruiting

  • Hospital do Câncer Mãe de Deus ( Site 0300)

    Porto Alegre, Rio Grande do Sul, 90470-340

    Study Coordinator, +555132344345

    Recruiting

  • Hospital de Câncer de Recife ( Site 0302)

    Recife, Pernambuco, 50040-000

    Study Coordinator, +558132178084

    Recruiting

  • Instituto de Oncologia Saint Gallen ( Site 0308)

    Santa Cruz do Sul, Rio Grande do Sul, 96830-180

    Study Coordinator, +555130568686

    Recruiting

  • Hospital Paulistano ( Site 0304)

    São Paulo, 01321-001

    Study Coordinator, +5511944716385

    Recruiting

Other trials in Brazil

Chile6 sites, 6 recruiting

  • Fundación Arturo López Pérez ( Site 0400)

    Santiago, Region M. de Santiago, 7500921

    Study Coordinator, +56224205098

    Recruiting

  • Oncovida ( Site 0402)

    Santiago, Region M. de Santiago, 7500994

    Study Coordinator, +56225992900

    Recruiting

  • Centro de Oncología de Precisión ( Site 0410)

    Santiago, Region M. de Santiago, 7560908

    Study Coordinator, +56225189885

    Recruiting

  • Clínica MEDS La Dehesa ( Site 0405)

    Santiago, Region M. de Santiago, 7691236

    Study Coordinator, +56224996400

    Recruiting

  • Bradfordhill ( Site 0401)

    Santiago, Region M. de Santiago, 8420383

    Study Coordinator, +56229490970

    Recruiting

  • CIDO SpA ( Site 0408)

    Temuco, Araucania, 4810218

    Study Coordinator, 56934016366

    Recruiting

Other trials in Chile

Italy6 sites, 6 recruiting

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 1507)

    Bergamo, Lombardy, 24127

    Study Coordinator, +390352674366

    Recruiting

  • Istituto Europeo di Oncologia IRCCS ( Site 1508)

    Milan, Lombardy, 20141

    Study Coordinator, +390257490439

    Recruiting

  • Ospedale San Raffaele. ( Site 1502)

    Milan, 20132

    Study Coordinator, +390226436530

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1501)

    Milan, 20133

    Study Coordinator, +390223902849

    Recruiting

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Oncologia Clinica Sperimentale di Senologia ( Site 1506)

    Naples, 80131

    Study Coordinator, +39 08117770442

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1500)

    Roma, 00144

    Study Coordinator, 00390630157337

    Recruiting

Other trials in Italy

South Korea6 sites, 6 recruiting

  • Gangnam Severance Hospital, Yonsei University Health System ( Site 2701)

    Gangnam-gu, Seoul, 06273

    Study Coordinator, +82220193305

    Recruiting

  • Samsung Medical Center ( Site 2704)

    Gangnam-gu, Seoul, 06351

    Study Coordinator, +82234101780

    Recruiting

  • Seoul National University Hospital ( Site 2702)

    Jongno-Gu, Seoul, 03080

    Study Coordinator, +82220720850

    Recruiting

  • Seoul National University Bundang Hospital ( Site 2703)

    Seongnam, Kyonggi-do, 13620

    Study Coordinator, +82317877384

    Recruiting

  • Severance Hospital Yonsei University Health System ( Site 2700)

    Seoul, 03722

    Study Coordinator, +82222288135

    Recruiting

  • Asan Medical Center ( Site 2705)

    Seoul, 05505

    Study Coordinator, +82230103217

    Recruiting

Other trials in South Korea

Australia5 sites, 5 recruiting

  • Blacktown Hospital-Blacktown Cancer and Haematology Centre - Medical Oncology ( Site 2300)

    Blacktown, New South Wales, 2148

    Study Coordinator, 02 8670 5077

    Recruiting

  • Chris O'Brien Lifehouse ( Site 2302)

    Camperdown, New South Wales, 2050

    Study Coordinator, +61 2 85140922

    Recruiting

  • Monash Medical Centre ( Site 2301)

    Clayton, Victoria, 3168

    Study Coordinator, +61 3 85722941

    Recruiting

  • The Alfred Hospital ( Site 2305)

    Melbourne, Victoria, 3004

    Study Coordinator, 03 9076 2000

    Recruiting

  • Sir Charles Gairdner Hospital ( Site 2304)

    Nedlands, Western Australia, 6009

    Study Coordinator, 08 6457 3333

    Recruiting

Other trials in Australia

Canada5 sites, 5 recruiting

  • The Moncton Hospital ( Site 0101)

    Moncton, New Brunswick, E1C 6Z8

    Study Coordinator, 5068575756

    Recruiting

  • Centre Hospitalier de l'Université de Montréal ( Site 0113)

    Montreal, Quebec, H2X 3E4

    Study Coordinator, 5148908000

    Recruiting

  • Saskatoon Cancer Centre ( Site 0106)

    Saskatoon, Saskatchewan, S7N 4H4

    Study Coordinator, 306-655-2662

    Recruiting

  • Sunnybrook Research Institute ( Site 0105)

    Toronto, Ontario, M4N 3M5

    Study Coordinator, 416-480-5248

    Recruiting

  • Princess Margaret Cancer Center ( Site 0116)

    Toronto, Ontario, M5G 2M9

    Study Coordinator, 416-946-4501

    Recruiting

Other trials in Canada

Colombia5 sites, 5 recruiting

  • FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0502)

    Bogotá, Bogota D.C., 110131

    Study Coordinator, (+57) 3183662238

    Recruiting

  • Instituto Nacional De Cancerologia ( Site 0504)

    Bogotá, Bogota D.C., 111511

    Study Coordinator, +57 3004224753

    Recruiting

  • Promotora Médica Las Américas S.A. ( Site 0503)

    Medellín, Antioquia, 050025

    Study Coordinator, +573043826133

    Recruiting

  • IMAT S.A.S ( Site 0500)

    Montería, Departamento de Córdoba, 230002

    Study Coordinator, +57 300 2152346

    Recruiting

  • Sociedad De Oncología y Hematología Del Cesar SAS ( Site 0501)

    Valledupar, Cesar Department, 200001

    Study Coordinator, +5755602310

    Recruiting

Other trials in Colombia

Germany5 sites, 5 recruiting

  • Klinikum Chemnitz gGmbH ( Site 1016)

    Chemnitz, Saxony, 09116

    Study Coordinator, 004937133322200

    Recruiting

  • Klinikum Lippe Detmold ( Site 1008)

    Detmold, North Rhine-Westphalia, 32756

    Study Coordinator, +49 5231 720

    Recruiting

  • Klinikum Dortmund Klinikzentrum Mitte ( Site 1005)

    Dortmund, North Rhine-Westphalia, 44137

    Study Coordinator, +4923195320733

    Recruiting

  • Universitaetsklinikum des Saarlandes-Klinik für Frauenheilkunde, Geburtshilfe und Reproduktionsmedi ( Site 1003)

    Homburg, Saarland, 66424

    Study Coordinator, +4968411628127

    Recruiting

  • Klinikum Mutterhaus der Borromäerinnen ( Site 1018)

    Trier, Rhineland-Palatinate, 54290

    Study Coordinator, +496519472636

    Recruiting

Other trials in Germany

Greece5 sites, 5 recruiting

  • "ALEXANDRA" GENERAL HOSPITAL OF ATHENS - DEPARTMENT OF CLINICAL THERAPEUTICS ( Site 1106)

    Athens, Attica, 115 28

    Study Coordinator, +302132162547

    Recruiting

  • General Hospital of Athens "Laiko" ( Site 1105)

    Athens, Attica, 11527

    Study Coordinator, 0030 2132060954

    Recruiting

  • Aretaieio Hospital ( Site 1103)

    Athens, Attica, 11528

    Study Coordinator, +302107286444

    Recruiting

  • University General Hospital of Heraklion ( Site 1102)

    Heraklion, Irakleio, 71500

    Study Coordinator, +302810392091

    Recruiting

  • European Interbalkan Medical Center-Oncology Department ( Site 1101)

    Thessaloniki, 570 01

    Study Coordinator, 0030 2310400213

    Recruiting

Other trials in Greece

Israel5 sites, 5 recruiting

  • Soroka Medical Center ( Site 1407)

    Beersheba, 8410101

    Study Coordinator, 97286244150

    Recruiting

  • Rambam Health Care Campus ( Site 1401)

    Haifa, 3109601

    Study Coordinator, 972-4-7776234

    Recruiting

  • Shaare Zedek Medical Center ( Site 1406)

    Jerusalem, 9103102

    Study Coordinator, 972-2-6555768

    Recruiting

  • Hadassah Medical Center ( Site 1404)

    Jerusalem, 9112001

    Study Coordinator, 972-2-6777111

    Recruiting

  • Sheba Medical Center ( Site 1400)

    Ramat Gan, 5265601

    Study Coordinator, 972-3-5304436

    Recruiting

Other trials in Israel

Mexico5 sites, 5 recruiting

  • Unidad de Mastologia Avanzada de Chihuahua S.A de C.V ( Site 0602)

    Chihuahua City, 31123

    Study Coordinator, +526144559270

    Recruiting

  • CIO - Centro de Inmuno-Oncología de Occidente ( Site 0600)

    Guadalajara, Jalisco, 44630

    Study Coordinator, +52 3330447001

    Recruiting

  • Laboratorio de Patología Clínica del Hospital Universitario "Dr. José Eleuterio González" ( Site 0604)

    Monterrey, Nuevo León, 64460

    Study Coordinator, +528183338111

    Recruiting

  • Centro de Investigacion Clinica de Oaxaca ( Site 0601)

    Oaxaca City, 68020

    Study Coordinator, +52 9516035559

    Recruiting

  • Cuidados Oncologicos. ( Site 0605)

    Querétaro City, Querétaro, 76000

    Study Coordinator, +52 4422428555

    Recruiting

Other trials in Mexico

Thailand5 sites, 5 recruiting

  • Faculty of Medicine Siriraj Hospital ( Site 2921)

    Bangkoknoi, Bangkok, 10700

    Study Coordinator, +6624141914

    Recruiting

  • Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 2924)

    Dusit, Bangkok, 10300

    Study Coordinator, +6622443461

    Recruiting

  • Songklanagarind Hospital ( Site 2922)

    Hat Yai, Changwat Songkhla, 90110

    Study Coordinator, +6674451469

    Recruiting

  • Maharaj Nakorn Chiang Mai Hospital ( Site 2925)

    Muang, Chiang Mai, 50200

    Study Coordinator, +6653935533

    Recruiting

  • Ramathibodi Hospital. ( Site 2923)

    Ratchathewi, Bangkok, 10400

    Study Coordinator, +6622011672

    Recruiting

Other trials in Thailand

United Kingdom5 sites, 5 recruiting

  • Leicester Royal Infirmary ( Site 2205)

    Leicester, LE1 5WW

    Study Coordinator, +44116 258 6295

    Recruiting

  • University College London Hospital ( Site 2206)

    London, England, NW1 2PG

    Study Coordinator, +442034472930

    Recruiting

  • St Bartholomew s Hospital ( Site 2200)

    London, London, City of, EC1A 7BE

    Study Coordinator, +442073777000

    Recruiting

  • Guy s and St Thomas Hospital NHS Foundation Trust ( Site 2201)

    London, London, City of, SE1 9RT

    Study Coordinator, +442071887188

    Recruiting

  • The Christie NHS Foundation Trust ( Site 2208)

    Manchester, M20 4BX

    Study Coordinator, +441614463000

    Recruiting

Other trials in United Kingdom

France4 sites, 4 recruiting

  • CHRU de Brest ( Site 0904)

    Brest, Finistere, 29200

    Study Coordinator, +33298233987

    Recruiting

  • CENTRE LEON BERARD ( Site 0900)

    Lyon, Rhone, 69008

    Study Coordinator, +33478782654

    Recruiting

  • Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen ( Site 0901)

    Rouen, Seine-Maritime, 76038

    Study Coordinator, +33232082220

    Recruiting

  • Gustave Roussy ( Site 0903)

    Villejuif, Val-de-Marne, 94800

    Study Coordinator, +33142116162

    Recruiting

Other trials in France

Hong Kong4 sites, 4 recruiting

  • Prince of Wales Hospital ( Site 3301)

    Hong Kong

    Study Coordinator, +852 3505 1138

    Recruiting

  • Princess Margaret Hospital. ( Site 3302)

    Hong Kong

    Study Coordinator, +852 2990 1111

    Recruiting

  • Queen Mary Hospital ( Site 3300)

    Hong Kong

    Study Coordinator, 39103339

    Recruiting

  • Tuen Mun Hospital ( Site 3303)

    Hong Kong

    Study Coordinator, +852 2468 5086

    Recruiting

Other trials in Hong Kong

Hungary4 sites, 4 recruiting

  • Semmelweis Egyetem-Belgyógyászati és Hematológiai Klinika ( Site 1202)

    Budapest, 1088

    Study Coordinator, +36 20 825 8397

    Recruiting

  • Országos Onkológiai Intézet-B-Belgyógyászati Onkológiai Osztály ( Site 1201)

    Budapest, 1122

    Study Coordinator, +3612248600

    Recruiting

  • Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 1200)

    Kecskemét, Bács-Kiskun county, 6000

    Study Coordinator, +3676516719

    Recruiting

  • Szabolcs Szatmár Bereg Vármegyei Oktatókórház Oncoradiology ( Site 1203)

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400

    Study Coordinator, +3642599700

    Recruiting

Other trials in Hungary

Peru4 sites, 4 recruiting

  • Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 0702)

    Concepción, Departamento de Junín, 12125

    Study Coordinator, +51958864658

    Recruiting

  • Clínica Internacional - Sede San Borja ( Site 0704)

    San Borja, Lima region, 15036

    Study Coordinator, 516196100

    Recruiting

  • Oncosalud ( Site 0700)

    San Borja, Lima region, 15036

    Study Coordinator, +5112053500 e2233

    Recruiting

  • IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0701)

    San Isidro, Lima region, 15036

    Study Coordinator, 512241598

    Recruiting

Other trials in Peru

Vietnam2 sites, 2 recruiting

  • Hanoi Oncology Hospital ( Site 3030)

    Hanoi, Hanoi, 100000

    Study Coordinator, +84 915546116

    Recruiting

  • Ho Chi Minh City Oncology Hospital ( Site 3032)

    Ho Chi Minh City, 700000

    Study Coordinator, +842836227722

    Recruiting

Other trials in Vietnam

About this study

Official title: An Open-label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan Monotherapy Versus Treatment of Physician's Choice in Hormone Receptor-positive, HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer (HERTHENA-Breast04).

Researchers are looking for other ways to treat breast cancer (BC) that is hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) and either unresectable locally advanced or metastatic.

  • HR positive (HR+) means the cancer cells have proteins that attach to estrogen or progesterone (hormones) which help the cancer to grow and spread
  • HER2 negative (HER2-) means the cancer cells have a low amount of a protein called HER2
  • Unresectable locally advanced means the cancer cannot be completely removed by surgery and has spread into nearby tissue or muscles
  • Metastatic means the cancer has spread to other parts of the body

Treatment for this type of breast cancer usually includes endocrine therapy (ET) and sometimes a second treatment. The main goal of this study is to learn if people who receive patritumab deruxtecan (also known as HER3-DXd and MK-1022) live longer overall or without the cancer growing/spreading, compared to people who receive chemotherapy or a different drug called trastuzumab deruxtecan.

Being tested
Patritumab deruxtecan, Paclitaxel, Nab-paclitaxel, Capecitabine, Pegylated liposomal doxorubicin
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patritumab deruxtecanBiological

    Also called MK-1022, HER3-DXd, U3-1402

    Administered via intravenous (IV) infusion

  • PaclitaxelDrug

    Also called TAXOL®, ONXAL®

    Administered via IV infusion

  • Nab-paclitaxelDrug

    Also called Abraxane®

    Administered via IV infusion

  • CapecitabineDrug

    Also called XELODA®

    Administered via oral tablets

  • Pegylated liposomal doxorubicinDrug

    Also called Doxil®

    Administered via IV infusion

  • Trastuzumab deruxtecanBiological

    Also called T-DXd, Enhertu®

    Administered via IV infusion

  • Rescue MedicationDrug

    Participants receive rescue medications according to each approved drug's product label. Recommended rescue medications include: 5-HT3 receptor antagonist, NK-1 receptor antagonist, and corticosteroids.

Study groups in NCT07060807
Study groupRoleWhat they receive
Patritumab DeruxtecanExperimentalParticipants receive patritumab deruxtecan via intravenous (IV) infusion every 3 weeks (Q3W) for approximately 13 months.
Receives: Biological: Patritumab deruxtecan; Drug: Rescue Medication
Treatment of Physician's ChoiceActive comparatorParticipants receive treatment of physician's choice (TPC) for up to 13 months. The TPC may be any of the following options: Paclitaxel (80 mg/m^2) on Days 1, 8, 15, and 22 of each 4-week cycle; Paclitaxel (90 mg/m^2) on Days 1, 8, and 15 of each 4-week cycle; Nab-paclitaxel (100 mg/m^2) on Days 1, 8, and 15 of each 4-week cycle; Capecitabine (1000 mg/m^2) bid on Days 1 to 14 of each 3-week cycle; Pegylated liposomal doxorubicin (50 mg/m^2) on Day 1 of each 4-week cycle; or trastuzumab deruxtecan (T-DXd) (5.4 mg/kg) Q3W.
Receives: Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Capecitabine; Drug: Pegylated liposomal doxorubicin; Biological: Trastuzumab deruxtecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    PFS is defined as the time from first day of study intervention to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by blinded independent central review (BICR). Per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.

    Measured: Up to approximately 45 months

  2. Overall Survival (OS)

    OS is the length of time from when the participant starts treatment until death from any cause.

    Measured: Up to approximately 85 months

Secondary outcomes (12)

  1. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by BICR.

    Measured: Up to approximately 85 months

  2. Duration of Response (DOR)

    For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.

    Measured: Up to approximately 85 months

  3. Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score

    The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to the questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and Quality of Life (QoL; "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better outcome. The change from baseline in GHS (EORTC QLQ-C30 Item 29) and QoL (EORTC QLQ-C30 Item 30) combined score (the standardized average of the raw scores) will be presented.

    Measured: Baseline and up to approximately 85 months

  4. Change from Baseline in the EORTC-QLQ-C30 Physical Functioning (Items 1-5) Combined Score

    The EORTC QLQ-C30 is a cancer specific health-related quality-of-life questionnaire. Participant responses to 5 questions about their physical functioning (Items 1-5) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores indicate better physical functioning. The change from baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) combined score (the standardized average of the raw scores) will be presented.

    Measured: Baseline and up to approximately 85 months

  5. Change from Baseline in the EORTC-QLQ-C30 Emotional Functioning (Items 1-5) Combined Score

    The EORTC QLQ-C30 is a cancer specific health-related quality-of-life questionnaire. Participant responses to 4 questions about their emotional functioning (Items 21-24) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores indicate better emotional functioning. The change from baseline in EORTC QLQ-C30 Emotional Functioning (Items 21-24) combined score (the standardized average of the raw scores) will be presented.

    Measured: Baseline and up to approximately 85 months

  6. Change from Baseline in the EORTC-QLQ-C30 Pain (Items 9 and 19) Combined Score

    The EORTC QLQ-C30 is a cancer specific health-related quality-of-life questionnaire. Participant responses to 2 questions about their pain (Items 9 and 19) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores indicate greater pain. The change from baseline in EORTC QLQ-C30 Pain (Items 9 and 19) combined score (the standardized average of the raw scores) will be presented.

    Measured: Baseline and up to approximately 85 months

  7. Time to First Deterioration (TTD) in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score

    The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to the questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and Quality of Life (QoL; "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better outcome. The TTD from baseline in GHS (EORTC QLQ-C30 Item 29) and QoL (EORTC QLQ-C30 Item 30) combined score (the standardized average of the raw scores), defined as the time from baseline to the first onset of a 10 or more points deterioration from baseline, will be presented.

    Measured: Baseline and up to approximately 85 months

  8. TTD in the EORTC-QLQ-C30 Physical Functioning (Items 1-5) Combined Score

    The EORTC QLQ-C30 is a cancer specific health-related quality-of-life questionnaire. Participant responses to 5 questions about their physical functioning (Items 1-5) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores indicate better physical functioning. The TTD from baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) combined score (the standardized average of the raw scores), defined as the time from baseline to the first onset of a 10 or more points deterioration from baseline, will be presented.

    Measured: Baseline and up to approximately 85 months

  9. TTD in the EORTC-QLQ-C30 Emotional Functioning (Items 1-5) Combined Score

    The EORTC QLQ-C30 is a cancer specific health-related quality-of-life questionnaire. Participant responses to 4 questions about their emotional functioning (Items 21-24) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores indicate better emotional functioning. The TTD from baseline in EORTC QLQ-C30 Emotional Functioning (Items 21-24) combined score (the standardized average of the raw scores) defined as the time from baseline to the first onset of a 10 or more points deterioration from baseline, will be presented.

    Measured: Baseline and up to approximately 85 months

  10. TTD in the EORTC-QLQ-C30 Pain (Items 9 and 19) Combined Score

    The EORTC QLQ-C30 is a cancer specific health-related quality-of-life questionnaire. Participant responses to 2 questions about their pain (Items 9 and 19) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. Higher scores indicate greater pain. The TTD from baseline in EORTC QLQ-C30 Pain (Items 9 and 19) combined score (the standardized average of the raw scores), will be presented.

    Measured: Baseline and up to approximately 85 months

  11. Number of Participants Who Experience One or More Adverse Event (AEs)

    An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who experience an AE will be presented.

    Measured: Up to approximately 85 months

  12. Number of Participants Who Discontinue Study Treatment Due to an AE

    An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The number of participants who discontinue study treatment due to an AE will be presented.

    Measured: Up to approximately 85 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2025
  2. Study start21 Jul 2025
  3. Primary completion14 Jul 2033 (estimated)
  4. Study completion14 Jul 2033 (estimated)

Resources

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
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07060807
Sponsor's protocol ID
1022-016
Other IDs
U1111-1317-5490, 2025-520582-51-00, jRCT2031250297, 2025
Status last verified
Oct 2026
First submitted
2 Jul 2025
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

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