Breast Cancer Clinical Trials

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A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin/Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer

Status: Recruiting
Location: See all (264) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Researchers are looking for new ways to treat types of breast cancer that are both: * High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment * Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone. Sacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread. The main goals of this study are to learn if people who receive sac-TMT, pembrolizumab, and chemotherapy: * Have fewer cancer cells found in the tumors and lymph nodes removed during surgery compared to those who receive only pembrolizumab and chemotherapy * Live longer without the cancer growing, spreading, or coming back compared to people who receive only pembrolizumab with chemotherapy

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

∙ The main inclusion criteria include but are not limited to the following:

• Has previously untreated high-risk, early-stage, non-metastatic (M0) breast cancer (BC), defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per AJCC 8th edition criteria as assessed by the investigator based on radiological and/or clinical assessment:

‣ cT1c, N1-N2

⁃ cT2, N0-N2

⁃ cT4a-d, N0-N2

• The participant must have a centrally confirmed diagnosis of BC that is triple-negative or HR-low+/HER2- (defined as estrogen receptor (ER)-low+ expression in 1% to 10% cells and HER2-), as by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.

• Provides a core needle biopsy from the primary breast tumor at screening to the central laboratory.

• Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 28 days before treatment randomization.

• Demonstrates adequate organ function.

Locations
United States
Arizona
Banner MD Anderson Cancer Center ( Site 0066)
RECRUITING
Gilbert
Mayo Clinic Cancer Center ( Site 0034)
RECRUITING
Phoenix
University of Arizona Cancer Center ( Site 0035)
RECRUITING
Tucson
California
Roy and Patricia Disney Family Cancer Center ( Site 0055)
RECRUITING
Burbank
Providence Medical Foundation ( Site 0080)
RECRUITING
Fullerton
Hoag Memorial Hospital Presbyterian ( Site 0010)
RECRUITING
Newport Beach
Helios Clinical Research ( Site 0061)
RECRUITING
Whittier
Colorado
Intermountain Health Cancer Center Saint Joseph ( Site 0062)
RECRUITING
Denver
Intermountain Health St. Mary's Regional Hospital ( Site 0054)
RECRUITING
Grand Junction
Florida
AdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0044)
RECRUITING
Altamonte Springs
Florida Cancer Specialists - South ( Site 7004)
RECRUITING
Fort Myers
Bioresearch Partner ( Site 0072)
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Hialeah
Mayo Clinic Hospital ( Site 0013)
RECRUITING
Jacksonville
Florida Cancer Specialists - North ( Site 7002)
RECRUITING
St. Petersburg
Indiana
Fort Wayne Medical Oncology and Hematology ( Site 0084)
RECRUITING
Fort Wayne
Franciscan Health ( Site 0077)
RECRUITING
Indianapolis
Louisiana
Ochsner Clinic Foundation ( Site 0021)
RECRUITING
New Orleans
Louisiana State University Health Sciences Shreveport ( Site 0053)
RECRUITING
Shreveport
Maryland
Mercy Medical Center - Baltimore ( Site 0015)
RECRUITING
Baltimore
Maine
New England Cancer Specialists ( Site 0051)
RECRUITING
Westbrook
Missouri
Saint Luke's Cancer Institute ( Site 0059)
RECRUITING
Kansas City
Washington University Siteman Cancer Center ( Site 0031)
RECRUITING
St Louis
North Dakota
Altru Health System ( Site 0057)
RECRUITING
Grand Forks
Nebraska
Cancer Partners of Nebraska ( Site 0068)
RECRUITING
Lincoln
New Jersey
Hackensack Univ Medical Center (HUMC) ( Site 0007)
RECRUITING
Hackensack
Rutgers Cancer Institute of New Jersey ( Site 0076)
RECRUITING
New Brunswick
Nevada
Optum Care Cancer Center ( Site 0050)
RECRUITING
Las Vegas
Renown Regional Medical Center ( Site 0041)
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Reno
Ohio
Good Samaritan Hospital-TriHealth Cancer institute ( Site 0027)
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Cincinnati
South Carolina
Medical University of South Carolina-Hollings Cancer Center ( Site 0016)
RECRUITING
Charleston
St Francis Cancer Center ( Site 0093)
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Greenville
South Dakota
Avera McKennan Hospital ( Site 0002)
RECRUITING
Sioux Falls
Avera Cancer Institute - Yankton ( Site 0089)
RECRUITING
Yankton
Tennessee
Tennessee Cancer Specialists ( Site 7001)
RECRUITING
Knoxville
Nashville General Hospital ( Site 0017)
RECRUITING
Nashville
Vanderbilt-Ingram Cancer Center ( Site 0038)
RECRUITING
Nashville
Texas
Hendrick Medical Center ( Site 0009)
RECRUITING
Abilene
JPS Oncology and Infusion Center ( Site 0083)
RECRUITING
Fort Worth
Kelsey-Seybold Clinic ( Site 0042)
RECRUITING
Houston
Kelsey-Seybold Clinic ( Site 0088)
RECRUITING
Houston
Oncology Consultants P.A. ( Site 0073)
RECRUITING
Houston
Texas Oncology - San Antonio ( Site 8004)
RECRUITING
San Antonio
Utah
Intermountain Medical Center ( Site 0074)
RECRUITING
Murray
Virginia
Bon Secours Cancer Institute at St. Francis ( Site 0048)
RECRUITING
Midlothian
Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 8005)
RECRUITING
Roanoke
Washington
Fred Hutchinson Cancer Center ( Site 0069)
RECRUITING
Seattle
Cancer Care Northwest ( Site 0003)
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Spokane
Northwest Medical Specialties, PLLC ( Site 0067)
RECRUITING
Tacoma
Wisconsin
University of Wisconsin-Madison ( Site 0024)
RECRUITING
Madison
Other Locations
Argentina
Centro de Educación Médica e Investigaciones clínicas Dr. Norberto Quirno (CEMIC) ( Site 6005)
RECRUITING
Buenos Aires
Hospital Italiano de Buenos Aires-ginecology ( Site 6003)
RECRUITING
Buenos Aires
Sanatorio Finochietto ( Site 6007)
RECRUITING
Buenos Aires
Sanatorio Allende - Nueva Córdoba ( Site 6000)
RECRUITING
Córdoba
Sanatorio de la Cañada - Córdoba ( Site 6001)
RECRUITING
Córdoba
Instituto de Investigaciones Clinicas Mar del Plata ( Site 6008)
RECRUITING
Mar Del Plata
Sanatorio Parque ( Site 6002)
RECRUITING
Rosario
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L ( Site 6006)
RECRUITING
San Miguel De Tucumán
Fundacion Ars Medica ( Site 6004)
RECRUITING
San Salvador De Jujuy
Australia
Chris O'Brien Lifehouse ( Site 1206)
RECRUITING
Camperdown
Monash Health ( Site 1201)
RECRUITING
Clayton
Macquarie University ( Site 1203)
RECRUITING
North Ryde
Belgium
AZORG Campus Aalst-Moorselbaan ( Site 3201)
RECRUITING
Aalst
UZ Gent ( Site 3202)
RECRUITING
Ghent
Jessa Ziekenhuis ( Site 3200)
RECRUITING
Hasselt
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 3204)
RECRUITING
Liège
CHU UCL Namur/Site Sainte Elisabeth ( Site 3203)
RECRUITING
Namur
Brazil
Fundação Pio XII - Hospital de Câncer de Barretos ( Site 6108)
RECRUITING
Barretos
Clínica de Oncologia Reichow ( Site 6112)
RECRUITING
Blumenau
PRONUTRIR ( Site 6120)
RECRUITING
Fortaleza
Hospital Araújo Jorge ( Site 6100)
RECRUITING
Goiânia
Liga Norte Riograndense Contra o Câncer ( Site 6111)
RECRUITING
Natal
Associação Hospitalar Beneficente São Vicente de Paulo ( Site 6115)
RECRUITING
Passo Fundo
Hospital São Lucas da PUCRS ( Site 6103)
RECRUITING
Porto Alegre
Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 6102)
RECRUITING
Porto Alegre
INCA Hospital do Câncer III ( Site 6107)
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Rio De Janeiro
Hospital de Base de São José do Rio Preto ( Site 6101)
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São José Do Rio Preto
Canada
Royal Victoria Regional Health Centre ( Site 0233)
RECRUITING
Barrie
Health Sciences North ( Site 0234)
RECRUITING
Greater Sudbury
Centre Hospitalier de l'Université de Montréal ( Site 0201)
RECRUITING
Montreal
Jewish General Hospital ( Site 0200)
RECRUITING
Montreal
McGill University Health Centre ( Site 0202)
RECRUITING
Montreal
Lakeridge Health ( Site 0225)
RECRUITING
Oshawa
The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0209)
RECRUITING
Ottawa
CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0203)
RECRUITING
Québec
Sault Area Hospital ( Site 0226)
RECRUITING
Sault Ste. Marie
CIUSSS de l'Estrie-CHUS ( Site 0206)
RECRUITING
Sherbrooke
NL Health Services ( Site 0232)
RECRUITING
St. John's
Princess Margaret Cancer Centre ( Site 0208)
RECRUITING
Toronto
Chile
Bradfordhill ( Site 6202)
RECRUITING
Santiago
Centro de Estudios Clínicos SAGA ( Site 6205)
RECRUITING
Santiago
FALP ( Site 6200)
RECRUITING
Santiago
ONCOCENTRO APYS ( Site 6204)
RECRUITING
Viña Del Mar
China
Beijing Cancer Hospital ( Site 2201)
RECRUITING
Beijing
The First Hospital Of Jilin University ( Site 2207)
RECRUITING
Changchun
Xiangya Hospital of Central South University ( Site 2225)
RECRUITING
Changsha
Deyang City People's Hospital ( Site 2244)
RECRUITING
Deyang
Guangdong Maternity and Child Health Care Hospital ( Site 2251)
RECRUITING
Guangzhou
Harbin Medical University Cancer Hospital ( Site 2204)
RECRUITING
Haerbin
The Second Affiliated Hospital of Zhejiang University School of Medicine ( Site 2212)
RECRUITING
Hangzhou
Zhejiang Cancer Hospital ( Site 2211)
ACTIVE_NOT_RECRUITING
Hangzhou
Zhejiang Provincial People's Hospital ( Site 2215)
RECRUITING
Hangzhou
Anhui Provincial Cancer Hospital ( Site 2234)
RECRUITING
Hefei
Jiangmen Center Hospital ( Site 2243)
RECRUITING
Jiangmen
Jinan Central Hospital ( Site 2249)
RECRUITING
Jinan
Shandong Cancer Hospital ( Site 2205)
RECRUITING
Jinan
Yunnan Province Cancer Hospital ( Site 2226)
RECRUITING
Kunming
LinYi Cancer Hospital ( Site 2248)
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Linyi
Liuzhou People's Hospital ( Site 2259)
RECRUITING
Liuchow
The Third Hospital Of Nanchang ( Site 2218)
RECRUITING
Nanchang
Jiangsu Province Hospital ( Site 2216)
RECRUITING
Nanjing
Nanjing Drum Tower Hospital ( Site 2217)
RECRUITING
Nanjing
Guangxi Medical University Affiliated Tumor Hospital ( Site 2223)
RECRUITING
Nanning
The Second People's Hospital of Neijiang ( Site 2242)
RECRUITING
Neijiang
Fudan University Shanghai Cancer Center ( Site 2209)
RECRUITING
Shanghai
Xinjiang Medical University Cancer Hospital - Urumqi ( Site 2230)
RECRUITING
Ürümqi
Renmin Hospital of Wuhan University ( Site 2236)
RECRUITING
Wuhan
Wuhan Union Hospital ( Site 2239)
RECRUITING
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 2203)
RECRUITING
Xi'an
The First Affiliated hospital of Xiamen University-Breast Surgery ( Site 2224)
RECRUITING
Xiamen
Henan Cancer Hospital ( Site 2238)
RECRUITING
Zhengzhou
Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 6309)
RECRUITING
Bogotá
FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 6311)
RECRUITING
Bogotá
Fundación Valle del Lili ( Site 6308)
RECRUITING
Cali
Instituto de Cancerología-Oncology ( Site 6302)
RECRUITING
Medellín
IMAT S.A.S ( Site 6300)
RECRUITING
Montería
Oncologos del Occidente ( Site 6303)
RECRUITING
Pereira
Finland
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 3600)
RECRUITING
Helsinki
Oulun yliopistollinen sairaala ( Site 3603)
RECRUITING
Oulu
Tampereen ylipistollinen sairaala ( Site 3601)
RECRUITING
Tampere
France
CHU d'Amiens-Picardie - Hôpital Sud ( Site 3908)
RECRUITING
Amiens
HENRI MONDOR HOSPITAL ( Site 3904)
RECRUITING
Créteil
Centre Georges Francois Leclerc ( Site 3902)
RECRUITING
Dijon
Institut Paoli Calmettes. ( Site 3906)
RECRUITING
Marseille
Centre de Cancerologie du Grand Montpellier ( Site 3910)
RECRUITING
Montpellier
Institut Curie ( Site 3903)
RECRUITING
Paris
Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer-Medical Oncology ( Site 3900)
RECRUITING
Rennes
Germany
Helios Klinikum Berlin-Buch ( Site 4008)
RECRUITING
Berlin
InVO Institut für Versorgungsforschung in der Onkologie ( Site 4009)
RECRUITING
Koblenz
CaritasKlinikum Saarbruecken St. Theresia ( Site 4014)
RECRUITING
Saarbrücken
Greece
Aretaieio Hospital Oncology Unit ( Site 4101)
RECRUITING
Athens
General Hospital of Athens - Laiko ( Site 4104)
RECRUITING
Athens
Metropolitan Hospital ( Site 4102)
RECRUITING
Athens
ATHENS MEDICAL CENTER ( Site 4100)
RECRUITING
Marousi
European Interbalkan Medical Center ( Site 4103)
RECRUITING
Thessaloniki
Guatemala
Asociacion Española de Beneficencia ( Site 6403)
RECRUITING
Guatemala City
CELAN,S.A ( Site 6401)
RECRUITING
Guatemala City
INTEGRA Cancer Institute ( Site 6404)
RECRUITING
Guatemala City
MEDI-K ( Site 6400)
RECRUITING
Guatemala City
Onco Go, S.A ( Site 6402)
RECRUITING
Guatemala City
Hong Kong Special Administrative Region
Hong Kong United Oncology Centre ( Site 1304)
RECRUITING
Jordan
Queen Mary Hospital ( Site 1300)
RECRUITING
Pokfulam
Prince of Wales Hospital ( Site 1301)
RECRUITING
Shatin
Tuen Mun Hospital ( Site 1303)
RECRUITING
Tuenmen
Hungary
Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 4207)
RECRUITING
Kecskemét
Borsod-Abaúj-Zemplén Vármegyei Központi Kórház És Egyetemi Oktatókórház ( Site 4208)
RECRUITING
Miskolc
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Onkoterapias Klinika ( Site 4202)
RECRUITING
Szeged
Israel
Rambam Health Care Campus ( Site 4400)
RECRUITING
Haifa
Meir Medical Center. ( Site 4403)
RECRUITING
Kfar Saba
Sheba Medical Center ( Site 4401)
RECRUITING
Ramat Gan
Yitzhak Shamir Medical Center. ( Site 4404)
RECRUITING
Ẕerifin
Italy
Azienda Ospedaliero Universitaria delle Marche ( Site 4509)
RECRUITING
Ancona
Azienda USL Toscana Nord Ovest_Ospedale Civile di Livorno ( Site 4503)
RECRUITING
Livorno
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 4501)
RECRUITING
Milan
Azienda Ospedaliero Universitaria Pisana ( Site 4506)
RECRUITING
Pisa
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 4500)
RECRUITING
Roma
Istituto Nazionale Tumori Regina Elena ( Site 4512)
RECRUITING
Roma
Japan
Akita University Hospital ( Site 2302)
RECRUITING
Akita
Chiba Cancer Center ( Site 2303)
RECRUITING
Chiba
National Cancer Center Hospital ( Site 2305)
RECRUITING
Chūō
Fukushima Medical University Hospital ( Site 2301)
RECRUITING
Fukushima
Kansai Medical University Hospital ( Site 2317)
RECRUITING
Hirakata
Hiroshima City Hiroshima Citizens Hospital ( Site 2318)
RECRUITING
Hiroshima
Kanazawa Medical University Hospital ( Site 2321)
RECRUITING
Kahoku-gun
Kumamoto Shinto General Hospital ( Site 2322)
RECRUITING
Kumamoto
Kyoto University Hospital ( Site 2313)
RECRUITING
Kyoto
National Hospital Organization Shikoku Cancer Center ( Site 2319)
RECRUITING
Matsuyama
Toranomon Hospital ( Site 2307)
RECRUITING
Minato
Nagoya City University Hospital ( Site 2310)
RECRUITING
Nagoya
Naha Nishi Clinic ( Site 2320)
RECRUITING
Naha
Nakagami Hospital ( Site 2323)
RECRUITING
Okinawa
National Hospital Organization Osaka National Hospital ( Site 2315)
RECRUITING
Osaka
Kindai University Hospital ( Site 2316)
RECRUITING
Sakai
National Hospital Organization Hokkaido Cancer Center ( Site 2300)
RECRUITING
Sapporo
Showa Medical University Hospital ( Site 2306)
RECRUITING
Shinagawa
The University of Osaka Hospital ( Site 2314)
RECRUITING
Suita
Shizuoka Cancer Center ( Site 2309)
RECRUITING
Sunto-gun
Mie University Hospital ( Site 2312)
RECRUITING
Tsu
Kanagawa Cancer Center ( Site 2308)
RECRUITING
Yokohama
Malaysia
Hospital Pulau Pinang ( Site 1502)
RECRUITING
George Town
Pantai Hospital Kuala Lumpur ( Site 1500)
RECRUITING
Kuala Lumpur
Sarawak General Hospital ( Site 1504)
RECRUITING
Kuching
University Malaya Medical Centre. ( Site 1503)
RECRUITING
Lembah Pantai
National Cancer Institute ( Site 1501)
RECRUITING
Putrajaya
New Zealand
Auckland City Hospital ( Site 1000)
RECRUITING
Auckland
Norway
Nordlandssykehuset ( Site 3704)
RECRUITING
Bodø
Drammen Sykehus, Vestre Viken HF ( Site 3700)
RECRUITING
Drammen
Akershus Universitetssykehus ( Site 3701)
RECRUITING
Lørenskog
Stavanger Universitetssjukehus ( Site 3702)
RECRUITING
Stavanger
Peru
Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 6605)
RECRUITING
Concepción
Hospital Guillermo Almenara Irigoyen ( Site 6601)
RECRUITING
Lima
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 6600)
RECRUITING
Lima
Oncosalud ( Site 6603)
RECRUITING
Lima
Instituto Regional de Enfermedades Neoplásicas Del Norte ( Site 6606)
RECRUITING
Trujillo
Philippines
THE MEDICAL CITY ( Site 1602)
RECRUITING
Pasig
Poland
Bialostockie Centrum Onkologii im.M.Sklodowskiej-Curie ( Site 4608)
RECRUITING
Bialystok
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 4616)
RECRUITING
Bydgoszcz
Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zaklad Opieki Zdrowotnej ( Site 4619)
RECRUITING
Kielce
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie ( Site 4611)
RECRUITING
Koszalin
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Oddzial w Krakowie ( Site 4612)
RECRUITING
Krakow
Salve Medica sp. z o.o. sp. k. ( Site 4618)
RECRUITING
Lodz
Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko-Mazurskim Centrum Onko ( Site 4614)
RECRUITING
Olsztyn
Wojewódzki Szpital Specjalistyczny im. J. Korczaka w Słupsku ( Site 4600)
RECRUITING
Słupsk
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 4609)
RECRUITING
Warsaw
Portugal
Hospital de Cascais Doutor José de Almeida ( Site 4700)
RECRUITING
Lisbon
Unidade Local de Saude Lisboa Ocidental - Hospital de São Francisco Xavier ( Site 4702)
RECRUITING
Lisbon
Instituto Portugues de Oncologia do Porto ( Site 4705)
RECRUITING
Porto
Republic of Korea
National Cancer Center ( Site 1800)
RECRUITING
Goyang-si
Seoul National University Bundang Hospital ( Site 1801)
RECRUITING
Kyonggi-do
Asan Medical Center ( Site 1803)
RECRUITING
Seoul
Samsung Medical Center ( Site 1807)
RECRUITING
Seoul
Seoul National University Hospital ( Site 1806)
RECRUITING
Seoul
Severance Hospital Yonsei University Health System ( Site 1804)
RECRUITING
Seoul
The Catholic University of Korea. Seoul St. Mary s Hospital ( Site 1802)
RECRUITING
Seoul
Kyungpook National University Chilgok Hospital ( Site 1805)
RECRUITING
Taegu
Romania
Spitalul Clinic Filantropia ( Site 4801)
RECRUITING
Bucharest
Institutul Oncologic Cluj ( Site 4802)
RECRUITING
Cluj-napoca
Singapore
National Cancer Centre Singapore ( Site 1700)
RECRUITING
Singapore
South Africa
Cancercare Rondebosch Oncology ( Site 4906)
RECRUITING
Cape Town
Wits Clinical Research ( Site 4903)
RECRUITING
Johannesburg
CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 4907)
RECRUITING
Port Elizabeth
LIFE GROENKLOOF-Mary Potter Cancer Centre ( Site 4901)
RECRUITING
Pretoria
Sandton Oncology Medical Group (Pty) Ltd ( Site 4900)
RECRUITING
Sandton
Spain
Parc de Salut Mar - Hospital del Mar ( Site 5005)
RECRUITING
Barcelona
Hospital de Basurto ( Site 5007)
RECRUITING
Bilbao
HOSPITAL UNIVERSITARIO DE JAEN ( Site 5003)
RECRUITING
Jaén
Institut Català d'Oncologia - L'Hospitalet ( Site 5001)
RECRUITING
L'hospitalet De Llobregat
Hospital Beata María Ana ( Site 5010)
RECRUITING
Madrid
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 5004)
RECRUITING
Pozuelo De Alarcón
Complejo asistencial universitario de Salamanca ( Site 5000)
RECRUITING
Salamanca
CHUS - Hospital Clinico Universitario ( Site 5006)
RECRUITING
Santiago De Compostela
Hospital Universitario Virgen Macarena ( Site 5002)
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Seville
Hospital General de Valencia ( Site 5008)
RECRUITING
Valencia
Sweden
Södra Älvsborgs Sjukhus Borås ( Site 3804)
RECRUITING
Borås
Skånes Universitetssjukhus Malmö ( Site 3802)
RECRUITING
Malmo
Karolinska Universitetssjukhuset Solna ( Site 3800)
RECRUITING
Stockholm
Akademiska sjukhuset ( Site 3801)
RECRUITING
Uppsala
Taiwan
Taichung Veterans General Hospital ( Site 1904)
RECRUITING
Taichung
MacKay Memorial Hospital ( Site 1903)
RECRUITING
Taipei
National Taiwan University Cancer Center (NTUCC) ( Site 1901)
RECRUITING
Taipei
National Taiwan University Hospital ( Site 1900)
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Taipei
Chang Gung Medical Foundation-Linkou Branch ( Site 1906)
RECRUITING
Taoyuan District
Thailand
Faculty of Medicine Siriraj Hospital ( Site 2000)
RECRUITING
Bangkok
Songklanagarind Hospital ( Site 2002)
RECRUITING
Hat Yai
Maharaj Nakorn Chiang Mai Hospital ( Site 2003)
RECRUITING
Muang
Chulalongkorn University ( Site 2001)
RECRUITING
Pathumwan
Ukraine
COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 5207)
RECRUITING
Cherkasy
Municipal Enterprise Bukovinian сlinical oncology сenter ( Site 5208)
RECRUITING
Chernivtsi
CNCE Precarpathian Clinical Oncologic Center ( Site 5201)
RECRUITING
Ivano-frankivsk
CNE Regional clinical oncology center of Kirovograd regional Council ( Site 5203)
RECRUITING
Kropyvnytsky
Shalimov Institute of Surgery and Transplantation ( Site 5210)
RECRUITING
Kyiv
United Kingdom
Ninewells Hospital and Medical School ( Site 5300)
RECRUITING
Dundee
Huddersfield Royal Infirmary ( Site 5313)
RECRUITING
Huddersfield
St Bartholomew s Hospital ( Site 5302)
RECRUITING
London
Princess Royal University Hospital ( Site 5316)
RECRUITING
Orpington
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2025-06-30
Estimated Completion Date: 2034-12-29
Participants
Target number of participants: 2400
Treatments
Experimental: sac-TMT
Participants receive sacituzumab tirumotecan intravenously (IV) at a dose of 4 mg/kg every 2 weeks (Q2W) + IV pembrolizumab 200 mg every 3 weeks (Q3W), for 12 weeks; then receive IV pembrolizumab 200 mg Q3W and IV carboplatin area under the curve (AUC) 1.5 + IV paclitaxel 80 mg/m\^2 once weekly, for 12 weeks. 3-6 weeks later, participants undergo surgery and optional radiation therapy, and receive IV pembrolizumab 400 mg once every 6 weeks or 200 mg Q3W for up to approximately 28 weeks. Additional adjuvant treatment of physician's choice (TPC) may be administered to participants with residual disease. TPC options are olaparib 300 mg oral twice daily (BID) for 1 year (participants with germline breast cancer susceptibility gene mutation (gBRCAm) only); capecitabine 1000-1250 mg/m\^2 oral twice daily on days 1-14 and 22-35 each cycle for 4 six-week cycles; or doxorubicin 60mg/m\^2 (or epirubicin 90 mg/m\^2) IV infusion Q3W/Q2W + cyclophosphamide 600 mg/m\^2 IV infusion Q3W/Q2W for 4 doses.
Active_comparator: Chemotherapy
Participants receive IV carboplatin AUC 1.5 and paclitaxel 80 mg/m\^2 once weekly, alongside pembrolizumab 200 mg Q3W, for 6 weeks; then receive IV pembrolizumab 200 mg Q3W alongside IV cyclophosphamide 600 mg/m\^2 Q3W and either doxorubicin 60 mg/m\^2 Q3W or epirubicin 90 mg/m\^2 Q3W, for up to 12 weeks. 3-6 weeks later, participants undergo surgery and optional radiation therapy, and receive IV pembrolizumab 400 mg once every 6 weeks or 200 mg Q3W for up to approximately 28 weeks. Additional adjuvant TPC may be administered to participants with residual disease. TPC options are olaparib 300 mg oral BID for 1 year (participants with germline breast cancer susceptibility gene mutation (gBRCAm) only); or capecitabine 1000-1250 mg/m\^2 oral BID on days 1-14 and 22-35 each cycle for 4 six-week cycles.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov

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