Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2024-512279-10 | Other Identifier | European Medicines Agency |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Alliance Foundation Trials, LLC. | OTHER |
| NSABP Foundation Inc | NETWORK |
| GBG Forschungs GmbH | OTHER |
Not provided
Not provided
Not provided
Not provided
The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sacituzumab govitecan-hziy (SG) + Pembrolizumab | Experimental | Participants will receive SG 10 mg/kg intravenously on Days 1 and 8 of 21-day cycles and pembrolizumab 200 mg intravenously on Day 1 of 21-day cycles for 8 cycles. Treatment will be administered until a maximum of 8 cycles, local or distant disease recurrence, unacceptable toxicity, physician decision, consent withdrawal, or death. |
|
| Treatment of Physician's Choice (TPC): Pembrolizumab or Pembrolizumab + Capecitabine | Active Comparator | Participants will receive one of the following TPC regimens determined prior to randomization:
Treatment will be administered until a maximum of 8 cycles, local or distant disease recurrence, unacceptable toxicity, physician decision, consent withdrawal, or death. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacituzumab govitecan-hziy (SG) | Drug | Administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Invasive Disease-free Survival (iDFS) | iDFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): invasive local, regional, or distant recurrence, invasive contralateral breast cancer. | Up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from the date of randomization until death due to any cause. | Up to 96 months |
| Distant Disease-free Survival (dDFS) | dDFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): distant recurrence, or second primary invasive cancer. |
Not provided
Key Inclusion Criteria:
Age > 18 years, with residual invasive triple negative breast cancer (TNBC) in the breast or lymph nodes after neoadjuvant therapy and surgery:
Adequate excision and surgical removal of all clinically evident of disease in the breast and/or lymph nodes and have adequately recovered from surgery.
Submission of both pre-neoadjuvant treatment diagnostic biopsy and resected residual invasive disease tissue.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Individuals must have received appropriate radiotherapy aligned with local/institutional practice and have recovered prior to starting study treatment.
Adequate organ function.
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Contact | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Oncology | Recruiting | Birmingham | Alabama | 35243 | United States | |
| Clearview Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38922307 | Derived | Tolaney SM, DeMichele A, Takano T, Rugo HS, Perou C, Lynce F, Parsons HA, Santa-Maria CA, Rocque GB, Yao W, Sun SW, Mocci S, Partridge AH, Carey LA. OptimICE-RD: sacituzumab govitecan + pembrolizumab vs pembrolizumab (+/- capecitabine) for residual triple-negative breast cancer. Future Oncol. 2024;20(31):2343-2355. doi: 10.1080/14796694.2024.2357534. Epub 2024 Jun 26. |
| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Pembrolizumab | Drug | Administered intravenously |
|
|
| Capecitabine | Drug | Tablets administered orally |
|
|
| Up to 60 months |
| Recurrence-free Survival (RFS) | RFS is defined as the time from the date of randomization to death from any cause or one of the following events (whichever occurs first): invasive local, regional, or distant recurrence. | Up to 60 months |
| Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | First dose date up to 38 months plus 30 days |
| Percentage of Participants Experiencing Laboratory Abnormalities | First dose date up to 38 months plus 30 days |
| Time to Worsening (TTW) of Quality of Life (QoL) Based on Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B) Trial Outcome Index (TOI) Scores | TTW of FACT-B TOI scores will be analyzed for each index, the TTW of FACT-B scores will be measured from the randomization date and to the time the participants first experienced a first score of worsening. | Up to 60 months |
| Recruiting |
| Huntsville |
| Alabama |
| 35805 |
| United States |
| Palo Verde Hematology Oncology | Recruiting | Glendale | Arizona | 85304 | United States |
| Mayo Clinic Hospital | Withdrawn | Phoenix | Arizona | 85054 | United States |
| Arizona Oncology Associates | Withdrawn | Prescott Valley | Arizona | 86314 | United States |
| Alta Bates Summit Medical Center | Recruiting | Berkeley | California | 94704 | United States |
| Community Cancer Institute | Withdrawn | Clovis | California | 93611 | United States |
| PIH Health Whittier Hospital | Recruiting | Downey | California | 90241 | United States |
| Compassionate Cancer Care Medical Group - Inc | Recruiting | Fountain Valley | California | 92708 | United States |
| Los Angeles Cancer Network | Recruiting | Los Angeles | California | 90017 | United States |
| USC Norris Comprehensive Cancer Center | Withdrawn | Los Angeles | California | 90033 | United States |
| Cedars-Sinai Cancer at Beverly Hills | Recruiting | Los Angeles | California | 90048 | United States |
| Hoag Memorial Hospital Presbyterian | Recruiting | Newport Beach | California | 92663 | United States |
| Emad Ibrahim, MD, INC | Withdrawn | Redlands | California | 92373 | United States |
| Sutter Institute for Medical Research | Recruiting | Sacramento | California | 95816 | United States |
| City of Hope (Duarte) | Recruiting | San Francisco | California | 94143 | United States |
| UCSF Medical Center | Recruiting | San Francisco | California | 94143 | United States |
| Sansum Clinic | Recruiting | Santa Barbara | California | 93105 | United States |
| Stockton Hematology Oncology Medical Group | Recruiting | Stockton | California | 95204 | United States |
| University of Colorado Cancer Center | Withdrawn | Aurora | Colorado | 80045 | United States |
| Norwalk Hospital | Withdrawn | Danbury | Connecticut | 06810 | United States |
| Stamford Hospital | Recruiting | Stamford | Connecticut | 06902 | United States |
| MedStar Georgetown University Hospital | Recruiting | Washington D.C. | District of Columbia | 20007 | United States |
| MedStar Washington Hospital Center | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
| Morton Plant Hospital - Bay Care | Withdrawn | Clearwater | Florida | 00337 | United States |
| University of Florida | Withdrawn | Gainesville | Florida | 32610 | United States |
| Mayo Clinic Florida | Recruiting | Jacksonville | Florida | 32224 | United States |
| Cancer Specialists of North Florida | Recruiting | Jacksonville | Florida | 32256 | United States |
| Jupiter Medical Center | Recruiting | Jupiter | Florida | 33458 | United States |
| Mount Sinai Comprehensive Cancer Center | Recruiting | Miami Beach | Florida | 33140 | United States |
| Midland Florida Clinical Research Center, L | Withdrawn | Orange City | Florida | 32763 | United States |
| Orlando Health | Active, not recruiting | Orlando | Florida | 32806 | United States |
| Cancer Care Centers of Brevard, Inc | Recruiting | Palm Bay | Florida | 32909 | United States |
| Memorial Healthcare System | Recruiting | Pembroke Pines | Florida | 33028 | United States |
| Sacred Heart Medical Oncology Group | Withdrawn | Pensacola | Florida | 32504 | United States |
| Sylvester Comprehensive Cancer Center | Recruiting | Plantation | Florida | 33324 | United States |
| Cleveland Clinic Florida, Martin North Hospital | Withdrawn | Stuart | Florida | 34994 | United States |
| St. Joseph's Hospital | Withdrawn | Tampa | Florida | 33614 | United States |
| Weston Hospital | Withdrawn | Weston | Florida | 33331 | United States |
| University Cancer & Blood Center, LLC. | Recruiting | Athens | Georgia | 30607 | United States |
| Piedmont Cancer Institute | Recruiting | Atlanta | Georgia | 30318 | United States |
| Northside Hospital | Recruiting | Atlanta | Georgia | 30342 | United States |
| Northwest Georgia Oncology Centers, PC | Recruiting | Marietta | Georgia | 30060 | United States |
| Southeastern Regional Medical Center, Inc. dba City of Hope Atlanta | Recruiting | Newnan | Georgia | 30265 | United States |
| Pearlman Cancer Center | Recruiting | Valdosta | Georgia | 31602 | United States |
| St Lukes Mountain States Tumor Institute | Withdrawn | Boise | Idaho | 83712 | United States |
| Kootenai Health | Recruiting | Coeur d'Alene | Idaho | 83814 | United States |
| Northwestern Medicine | Recruiting | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center | Recruiting | Chicago | Illinois | 60612 | United States |
| University of Illinois | Withdrawn | Chicago | Illinois | 60612 | United States |
| University of Chicago Medical Center | Recruiting | Chicago | Illinois | 60637 | United States |
| NorthShore University Healthsystem | Recruiting | Evanston | Illinois | 60201 | United States |
| Edward Hospital | Recruiting | Naperville | Illinois | 60540 | United States |
| West Suburban Medical Center- River Forest | Withdrawn | River Forest | Illinois | 60305 | United States |
| Edward H. Kaplan MD & Associates - Hematology/Oncology of the North Shore | Withdrawn | Skokie | Illinois | 60076 | United States |
| Springfield Clinic LLP | Withdrawn | Springfield | Illinois | 62702 | United States |
| Carle Cancer Center | Recruiting | Urbana | Illinois | 61801 | United States |
| Franciscan Health Indianapolis | Recruiting | Indianapolis | Indiana | 46237 | United States |
| Investigative Clinical Research of Indiana, LLC | Withdrawn | Indianapolis | Indiana | 46260 | United States |
| IU Health Arnett Hospital | Withdrawn | Lafayette | Indiana | 47904 | United States |
| Franciscan Health Munster | Withdrawn | Munster | Indiana | 46321 | United States |
| Mercy Medical Center | Withdrawn | Cedar Rapids | Iowa | 52403 | United States |
| Mission Cancer & Blood - John Stoddard Cancer Center | Recruiting | Des Moines | Iowa | 50309 | United States |
| University of Iowa Hospitals and Clinics | Recruiting | Iowa City | Iowa | 52242 | United States |
| Cancer Center of Kansas | Recruiting | Wichita | Kansas | 67214 | United States |
| University of Kentucky | Withdrawn | Lexington | Kentucky | 40536 | United States |
| Norton Healthcare, Inc. | Recruiting | Louisville | Kentucky | 40207 | United States |
| Mercy Health | Recruiting | Paducah | Kentucky | 42003 | United States |
| Mary Bird Perkins Cancer Center | Recruiting | Baton Rouge | Louisiana | 70809 | United States |
| University Medical Center New Orleans | Withdrawn | New Orleans | Louisiana | 70112 | United States |
| New England Cancer Specialists | Recruiting | Scarborough | Maine | 04074 | United States |
| Sinai Hospital of Baltimore, Inc. | Recruiting | Baltimore | Maryland | 21215 | United States |
| St. Agnes Hospital | Recruiting | Baltimore | Maryland | 21229 | United States |
| Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center | Recruiting | Baltimore | Maryland | 21231 | United States |
| American Oncology Partners of Maryland, PA | Withdrawn | Bethesda | Maryland | 20817 | United States |
| James M Stockman Cancer Institute | Recruiting | Frederick | Maryland | 21702 | United States |
| Greater Baltimore Medical Center | Recruiting | Towson | Maryland | 21204 | United States |
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
| Dana Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
| Dana-Farber Cancer Institute @Foxborough | Recruiting | Foxborough | Massachusetts | 02035 | United States |
| Dana-Farber Cancer Institude at Merrimack Valley | Recruiting | Methuen | Massachusetts | 01844 | United States |
| Dana Farber Cancer Institute @ Milford Regional Hospital | Recruiting | Milford | Massachusetts | 01757 | United States |
| Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) in Clinical Affiliation with South Shore Hospital | Recruiting | South Weymouth | Massachusetts | 02190 | United States |
| Baystate Medical Center Inc. | Withdrawn | Springfield | Massachusetts | 01199 | United States |
| University of Massachusetts Worcester | Withdrawn | Worcester | Massachusetts | 01655 | United States |
| Henry Ford Health System | Withdrawn | Detroit | Michigan | 48202 | United States |
| Cancer and Hematology Centers of Western Michigan | Recruiting | Grand Rapids | Michigan | 49503 | United States |
| Ascension | Withdrawn | Grosse Pointe Woods | Michigan | 48236 | United States |
| William Beaumont Hospital | Recruiting | Royal Oak | Michigan | 48073 | United States |
| Ascension Providence Hospital Southfield Cancer Center | Withdrawn | Southfield | Michigan | 48075 | United States |
| Trinity Health St. Joseph Mercy Ann Arbor | Withdrawn | Ypsilanti | Michigan | 48197 | United States |
| Minnesota Oncology Hematology, PA | Recruiting | Maplewood | Minnesota | 55109 | United States |
| Virginia Piper Cancer Center (Allina Health) | Recruiting | Minneapolis | Minnesota | 55407 | United States |
| University of Minnesota Medical Center, Fairview | Recruiting | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
| Metro Minnesota Community Oncology | Recruiting | Saint Louis Park | Minnesota | 55426 | United States |
| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
| Baptist Clinical Research Institute | Recruiting | St Louis | Missouri | 63131 | United States |
| Mercy Hospital | Withdrawn | St Louis | Missouri | 63141 | United States |
| Mary Lanning Healthcare - Morrison Cancer Center | Active, not recruiting | Hastings | Nebraska | 68901 | United States |
| Oncology Hematology West - Methodist | Recruiting | Omaha | Nebraska | 68114 | United States |
| Nebraska Methodist Hospital (change from Chi Health Bergan Mercy) | Recruiting | Omaha | Nebraska | 68124 | United States |
| Comprehensive Cancer Centers of Nevada | Withdrawn | Las Vegas | Nevada | 89169 | United States |
| Cancer Care & Hematology Specialists | Withdrawn | Reno | Nevada | 89511 | United States |
| Regional Cancer Care Associates LLC | Recruiting | East Brunswick | New Jersey | 08816 | United States |
| Hunterdon Medical Center | Recruiting | Flemington | New Jersey | 08822 | United States |
| Summit Medical Group, P.A. | Withdrawn | Florham Park | New Jersey | 07932 | United States |
| Rutgers Health | Recruiting | New Brunswick | New Jersey | 08901 | United States |
| Overlook Medical Center | Recruiting | Summit | New Jersey | 07901 | United States |
| University of New Mexico | Recruiting | Albuquerque | New Mexico | 87131 | United States |
| San Juan Oncology Associates | Recruiting | Farmington | New Mexico | 87401 | United States |
| New York Oncology Hematology (NYOH) | Withdrawn | Amsterdam | New York | 12010 | United States |
| Roswell Park Cancer Institute | Withdrawn | Buffalo | New York | 14263 | United States |
| Hematology Oncology Associates of Central New York, PC | Recruiting | East Syracuse | New York | 13057 | United States |
| Northwell Health | Recruiting | Lake Success | New York | 11042 | United States |
| Laura and Isaac Perlmutter Cancer Canter | Recruiting | New York | New York | 10016 | United States |
| Lipson Cancer Institute - Linden Oaks | Recruiting | Rochester | New York | 14618 | United States |
| New York Cancer and Blood Specialists | Recruiting | Shirley | New York | 11967 | United States |
| Stony Brook Medicine | Recruiting | Stony Brook | New York | 11794 | United States |
| SUNY Upstate Medical University | Recruiting | Syracuse | New York | 13210 | United States |
| Montefiore Medical Center | Withdrawn | The Bronx | New York | 10467 | United States |
| Clinical Research Alliance | Withdrawn | Westbury | New York | 11590 | United States |
| White Plains Hospital Physician Associates | Recruiting | White Plains | New York | 10601 | United States |
| Lineberger Comprehensive Cancer Center | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
| Duke Cancer Institute | Recruiting | Durham | North Carolina | 27710 | United States |
| Cone Health Medical Group (Moses Cone Health System) | Recruiting | Greensboro | North Carolina | 27403 | United States |
| East Carolina University Health Medical Center | Withdrawn | Greenville | North Carolina | 27834 | United States |
| FirstHealth Outpatient Cancer Center | Withdrawn | Pinehurst | North Carolina | 28374 | United States |
| UNC Rex Cancer Center | Withdrawn | Raleigh | North Carolina | 27607 | United States |
| UNC Nash Cancer Center | Withdrawn | Rocky Mount | North Carolina | 27804 | United States |
| Atrium Health Wake Forest Baptist | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
| Good Samaritan Hospital | Recruiting | Cincinnati | Ohio | 45220 | United States |
| Oncology Hematology Care, Inc. | Recruiting | Cincinnati | Ohio | 45242 | United States |
| Ohio State University CRS | Recruiting | Columbus | Ohio | 43212 | United States |
| Ohio Health Research Institute | Recruiting | Columbus | Ohio | 43214 | United States |
| Columbus NCORP | Recruiting | Columbus | Ohio | 43215 | United States |
| Anita Stewart Oncology Center | Recruiting | Columbus | Ohio | 43221 | United States |
| Toledo Clinic Cancer Center | Not yet recruiting | Toledo | Ohio | 43623 | United States |
| University of Oklahoma Health Sciences Center | Withdrawn | Oklahoma City | Oklahoma | 73104 | United States |
| St. Charles Health System, Inc. DBA St. Charles Medical Center | Recruiting | Bend | Oregon | 97701 | United States |
| Samaritan Hospital | Recruiting | Corvallis | Oregon | 97330 | United States |
| Willamette Valley Cancer Institute and Research Center | Recruiting | Eugene | Oregon | 97401 | United States |
| Asante Rogue Regional Medical Center | Withdrawn | Medford | Oregon | 97504 | United States |
| Providence Cancer Institute - Oncology Clinical Trials | Withdrawn | Portland | Oregon | 97213 | United States |
| Oregon Health & Science University | Recruiting | Portland | Oregon | 97239 | United States |
| Saint Luke's University Hospital | Withdrawn | Bethlehem | Pennsylvania | 18015 | United States |
| Lancaster General Health | Recruiting | Lancaster | Pennsylvania | 17601 | United States |
| University of Pennsylvania Abramson Cancer Center | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| UPMC Magee-Womens Hospital | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
| Guthrie Clinical Research | Recruiting | Sayre | Pennsylvania | 18840 | United States |
| Reading Hospital and Medical Center | Withdrawn | West Reading | Pennsylvania | 19611 | United States |
| Lankenau Medical Center | Recruiting | Wynnewood | Pennsylvania | 19106 | United States |
| Cancer Care Associates of York | Recruiting | York | Pennsylvania | 17403 | United States |
| Providence Health | Recruiting | Providence | Rhode Island | 02905 | United States |
| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29425 | United States |
| Spartanburg Medical Center | Recruiting | Spartanburg | South Carolina | 29303 | United States |
| Monument Health Cancer Care Institute | Recruiting | Rapid City | South Dakota | 57701 | United States |
| Avera Cancer Institute | Recruiting | Sioux Falls | South Dakota | 57105 | United States |
| Ballad Health Cancer Care - Kingsport | Withdrawn | Kingsport | Tennessee | 37660 | United States |
| Center for Biomedical Research, LLC | Withdrawn | Knoxville | Tennessee | 37909 | United States |
| University of Tennessee | Recruiting | Knoxville | Tennessee | 37920 | United States |
| Hendrick Health System | Withdrawn | Abilene | Texas | 79601 | United States |
| Texas Oncology | Recruiting | Austin | Texas | 78731 | United States |
| Texas Oncology | Recruiting | El Paso | Texas | 79902 | United States |
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| Joe Arrington Cancer Research and Treatment Center | Withdrawn | Lubbock | Texas | 79410 | United States |
| Texas Oncology | Recruiting | San Antonio | Texas | 78240 | United States |
| Huntsman Cancer Institute | Recruiting | Salt Lake City | Utah | 84112 | United States |
| University of Virginia | Recruiting | Charlottesville | Virginia | 22908 | United States |
| Inova Fairfax Hospital | Recruiting | Fairfax | Virginia | 22031 | United States |
| Bon Secours Cancer Institute at St. Francis | Recruiting | Midlothian | Virginia | 23114 | United States |
| Virginia Commonwealth University Medical Center | Withdrawn | Richmond | Virginia | 23298 | United States |
| Oncology and Hematology Associates of Southwest Virginia, Inc | Recruiting | Wytheville | Virginia | 24382 | United States |
| Providence Regional Cancer System | Recruiting | Lacey | Washington | 98503 | United States |
| MultiCare Regional Cancer Center - Tacoma | Recruiting | Puyallup | Washington | 98372 | United States |
| Northwest Medical Specialties, PLLC | Recruiting | Puyallup | Washington | 98373 | United States |
| University of Washington | Withdrawn | Renton | Washington | 98055 | United States |
| Medical Oncology Associates | Withdrawn | Spokane | Washington | 99208 | United States |
| West Virginia University Hospital | Recruiting | Morgantown | West Virginia | 26505 | United States |
| ThedaCare Regional Cancer Center | Withdrawn | Appleton | Wisconsin | 54911 | United States |
| Ascension St. Francis Reiman Cancer Center | Recruiting | Franklin | Wisconsin | 53132 | United States |
| HSHS Saint Mary's Hospital Medical Center - Green Bay | Withdrawn | Green Bay | Wisconsin | 54303 | United States |
| University of Wisconsin | Withdrawn | Madison | Wisconsin | 53792 | United States |
| Macarthur Cancer Therapy Centre, Campbelltown Hospital | Recruiting | Campbelltown | New South Wales | 2560 | Australia |
| Kinghorn Cancer Centre | Recruiting | Darlinghurst | New South Wales | 2010 | Australia |
| Lake Macquarie Private Hospital | Recruiting | Gateshead | New South Wales | 2290 | Australia |
| Port Macquarie Base Hospital | Recruiting | Port Macquarie | New South Wales | 2444 | Australia |
| Cairns Hospital | Recruiting | Cairns | Queensland | 4870 | Australia |
| Princess Alexandra Hospital | Recruiting | Woolloongabba | Queensland | 4102 | Australia |
| Cancer Research SA | Recruiting | Adelaide | South Australia | 5000 | Australia |
| Bendigo Health | Recruiting | Bendigo | Victoria | 3551 | Australia |
| Monash Medical Centre | Recruiting | Clayton | Victoria | 3168 | Australia |
| Fiona Stanley Hospital | Recruiting | Murdoch | Western Australia | 6150 | Australia |
| Chirec Delta Hospital | Active, not recruiting | Brussels | 1160 | Belgium |
| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
| Clinique CHC MontLégia | Active, not recruiting | Liège | 4000 | Belgium |
| AZ Delta vzw | Active, not recruiting | Roeselare | 8800 | Belgium |
| Ziekenhuls aan de Stroom vzw (ZAS vzw), ZAS Augustinus | Recruiting | Wilrijk | 2610 | Belgium |
| St. de Habitações Individuais Sul QI 15 - Lago Sul, Brasília - DF, Brasil | Recruiting | Brasília | 71681-603 | Brazil |
| Rua Myltho Anselmo da Silva, 870 - Mercês, Curitiba - PR, CEP 80510-130 | Recruiting | Curitiba | 80510-130 | Brazil |
| Oncosite | Recruiting | Ijuí | 98700-000 | Brazil |
| R. Aderbal Ramos da Silva, 148 - Centro, Itajaí - SC, 88300-000, Brasil | Recruiting | Itajaí | 88300-000 | Brazil |
| Av. Miguel Castro, 1355, Nossa Senhora de Nazaré, Natal/RN | Recruiting | Natal | 59062-200 | Brazil |
| Rua Professor Annes Dias, 295 - Centro Histórico, Porto Alegre - RS, , Brasil | Recruiting | Porto Alegre | 90020-090 | Brazil |
| Av. Soledad, 569, sala 1103, Três Figueiras, CEP 90470-340 | Recruiting | Porto Alegre | 90470-340 | Brazil |
| Av. Ipiranga 6690 | Recruiting | Porto Alegre | 90610-000 | Brazil |
| Av. Milton Santos, 123 - Ondina, Salvador - BA, , Brasil | Recruiting | Salvador | 40170-110 | Brazil |
| AMO Clinic - Rio Vermelho | Active, not recruiting | Salvador | 41950-640 | Brazil |
| Av. Brigadeiro Luís Antônio 733, loja 8 | Recruiting | São Paulo | 01317-000 | Brazil |
| Martiiano de Carvalho 965 | Recruiting | São Paulo | 01323-001 | Brazil |
| CIPE Centro Internacional de Pesquisa; A.C. Camargo Cancer Center | Recruiting | São Paulo | 01509-010 | Brazil |
| Rua Gardênia, 710, Edifício Prime, 4º andar, Bairro Jóquei, Teresina - PI, CEP 60449-200 | Recruiting | Teresina | 60449-200 | Brazil |
| CHU Amiens Picardie | Recruiting | Amiens | 80000 | France |
| Pôle Santé Léonard De Vinci - ROC37 | Recruiting | Chambray-lès-Tours | 37170 | France |
| Clinique Victor Hugo | Recruiting | Le Mans | 72000 | France |
| chu de Limoges | Recruiting | Limoges | 87042 | France |
| Institut de Cancérologie de l'Ouest (ICO) - St Herblain | Recruiting | Loire Atlantique | 44 805 | France |
| Hôpital Privé Jean Mermoz | Recruiting | Lyon | 69008 | France |
| Centre D'Oncologie de Gentilly | Recruiting | Nancy | 54000 | France |
| L'Hôpital Privé du Confluent | Recruiting | Nantes | 44277 | France |
| CHU de Nimes | Recruiting | Nîmes | 30029 | France |
| Hopital Privé des Côtes d'Armor - Centre CARIO-HPCA | Recruiting | Plérin | 22190 | France |
| CHU de Poitiers, 2 Rue de la Milétrie | Recruiting | Poitiers | 86021 | France |
| Centre Eugène Marquis | Recruiting | Rennes | 35042 | France |
| Oncopole Claudius Regaud - IUCT-O | Recruiting | Toulouse | 31059 | France |
| Hämatologie-Onkologie im Zentrum MVZ GmbH | Recruiting | Augsburg | 86150 | Germany |
| Schwanebecker Chaussee 50 | Active, not recruiting | Berlin | 13125 | Germany |
| Möllendorffstr. 52, 10367 Berlin 2. Behandlungsstandort: Markt 2-3, 13597 Berlin | Recruiting | Berlin | 13597 | Germany |
| Teutoburger Str. 60 | Recruiting | Bielefeld | 33604 | Germany |
| Josef-Albers-Str.70 | Recruiting | Bottrop | 46236 | Germany |
| Studien GbR Braunschweig | Recruiting | Braunschweig | 38100 | Germany |
| St.-Juergen-Str. 1 | Recruiting | Bremen | 28205 | Germany |
| Hämato-Onkologische Praxis im Medicum | Recruiting | Bremen | 28209 | Germany |
| St. Elisabeth Krankenhaus GmbH | Recruiting | Cologne | 50935 | Germany |
| St. Johannes Hospital | Recruiting | Dortmund | 44137 | Germany |
| Fetscherstraße ,74 | Recruiting | Dresden | 01307 | Germany |
| Kostara Gyn. Oncology Clinic Research UG | Recruiting | Düsseldorf | 40235 | Germany |
| Universitätsstraße, 21-23 | Recruiting | Erlangen | 91054 | Germany |
| Henricistraße 92, 45136 Essen, Germany | Recruiting | Essen | 45136 | Germany |
| Klinikum Esslingen | Recruiting | Esslingen am Neckar | 73730 | Germany |
| Gotenstraße 6-8 | Recruiting | Frankfurt am Main | 65929 | Germany |
| Hugstetter Str. 55 | Recruiting | Freiburg im Breisgau | 79106 | Germany |
| Munckelstrasse 27 | Recruiting | Gelsenkirchen | 45879 | Germany |
| MVZ II der Niels Stensen Kliniken | Recruiting | Georgsmarienhütte | 49124 | Germany |
| Straße des Friedens 122 | Recruiting | Gera | 7548 | Germany |
| Hohe Weide 17b | Recruiting | Hamburg | 20259 | Germany |
| Moorkamp 2-6 | Recruiting | Hamburg | 20357 | Germany |
| Am Klinikum 1 | Recruiting | Jena | 07447 | Germany |
| Edgar-von-Gierke-Straße 2 | Active, not recruiting | Karlsruhe | 76137 | Germany |
| Elisabeth Krankenhaus Brustzentrum | Recruiting | Kassel | 34117 | Germany |
| Arnold-Heller-Str. 3 Haus C | Recruiting | Kiel | 24105 | Germany |
| InVO - Institut für Versorgungsforschung in der Onkologie GbR / Praxis für Hämatologie und Onkologie | Recruiting | Koblenz | 56068 | Germany |
| Lutherplatz 40 | Recruiting | Krefeld | 47805 | Germany |
| Fachärztezentrum Langen | Recruiting | Langen | 63225 | Germany |
| Liebigstraße 20 | Recruiting | Leipzig | 04103 | Germany |
| Biedermannstrasse 84 | Recruiting | Leipzig | 4277 | Germany |
| Universitätsklinikum Mannheim | Recruiting | Mannheim | 68167 | Germany |
| Taxisstrasse 3 | Recruiting | Munich | 80637 | Germany |
| Bei der Marienkirche 6 | Not yet recruiting | Mühlhausen | 99974 | Germany |
| Albert-Schweitzer-Campus 1, Building A1, | Recruiting | Münster | 48149 | Germany |
| Starkenburgring 66, 63069 Offenbach | Recruiting | Offenbach | 63069 | Germany |
| Rahel-Straus-Straße 10 | Recruiting | Oldenburg | 26133 | Germany |
| Husenerstr. 81 | Recruiting | Paderborn | 33098 | Germany |
| Charlottenstraße 72 | Recruiting | Potsdam | 14467 | Germany |
| Elisabethenstr. 19, 88212 Ravensburg | Recruiting | Ravensburg | 88212 | Germany |
| Südring 81 | Recruiting | Rostock | 18059 | Germany |
| Wismarsche Strasse 393-397 | Recruiting | Schwerin | 19055 | Germany |
| Harsefelderstraße 8 | Active, not recruiting | Stade | 21680 | Germany |
| Böheimstr. 37 | Active, not recruiting | Stuttgart | 70199 | Germany |
| Schierghoferstrasse 1 | Recruiting | Traunstrein | 83278 | Germany |
| Calwerstrasse 7 | Recruiting | Tübingen | 72076 | Germany |
| Prittwitzstr. 43 | Recruiting | Ulm | 89075 | Germany |
| Beethovenstrasse 20 | Recruiting | Wiesbaden | 65189 | Germany |
| Marienplatz 2 | Not yet recruiting | Witten | 58455 | Germany |
| Klinikum Worms Frauenklinik | Recruiting | Worms | 67550 | Germany |
| Helios University Hospital University Witten/Herdecke | Recruiting | Wuppertal | 42283 | Germany |
| Mater Misericordiae University Hospital | Recruiting | Dublin | D07 R2WY | Ireland |
| St James's Hospital | Recruiting | Dublin | D08NH41 | Ireland |
| Beaumont Hospital | Recruiting | Dublin | D09V2N0 | Ireland |
| University Hospital Limerick | Not yet recruiting | Limerick | V94 F858 | Ireland |
| Cork University Hospital | Recruiting | Wilton | T12 DC4A | Ireland |
| IRCCS Istituto Tumori "Giovanni Paolo II" | Recruiting | Bari | 70124 | Italy |
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Active, not recruiting | Bologna | 40138 | Italy |
| Azienda Ospedaliera Universitaria Careggi | Active, not recruiting | Florence | 50134 | Italy |
| Istituto Romagnolo Per Lo Studio Dei Tumori (IRST) 'Dino Amadori? IRCCS | Recruiting | Meldola | 47014 | Italy |
| Humanitas Istituto Clinico Catanese | Recruiting | Misterbianco | 95125 | Italy |
| AOU Modena | Recruiting | Modena | 41125 | Italy |
| IRCCS Fondazione G. Pascale | Recruiting | Naples | 80131 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | Roma | 168 | Italy |
| Fondazione Policlinico Universitario Campus Bio-Medico di Roma | Recruiting | Rome | 00128 | Italy |
| ASST Papa Giovanni XXIII | Active, not recruiting | Rozzano | 20089 | Italy |
| AOU Città della Salute e della Scienza di Torino | Recruiting | Torino | 10123 | Italy |
| Ospedale Santa Chiara | Recruiting | Trento | 38122 | Italy |
| Soonchunhyang University Cheonan Hospital | Recruiting | Chungcheongnam-do | 31151 | South Korea |
| Kyungpook National University Chilgok Hospital | Recruiting | Daegu | 41404 | South Korea |
| Seoul National University Bundang Hospital | Recruiting | Gyeonggi-do | 13620 | South Korea |
| Severance Hospital | Recruiting | Seodaemun-gu | 3722 | South Korea |
| Korea University Anam Hospital | Recruiting | Seoul | 02841 | South Korea |
| Asan Medical Center | Recruiting | Seoul | 05505 | South Korea |
| Gangnam Severance Hospital | Recruiting | Seoul | 06273 | South Korea |
| Seoul National University Hospital | Recruiting | Seoul | 3080 | South Korea |
| Samsung Medical Center | Recruiting | Seoul | 6351 | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Recruiting | Seoul | South Korea |
| Medical Oncology Unit. A Coruña University Hospital | Recruiting | A Coruña | 15006 | Spain |
| ICO Badalona - Hospital Germans Trias I Pujol | Recruiting | Badalona | 08916 | Spain |
| Hospital Universitary of Cruces | Recruiting | Barakaldo | 48903 | Spain |
| Hospital Clinic de Barcelona | Recruiting | Barcelona | 08036 | Spain |
| Hospital del Mar | Recruiting | Barcelona | 8003 | Spain |
| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | 8041 | Spain |
| Consorcio Hospitalario Provincial de Castellón | Recruiting | Castellon | 12002 | Spain |
| Hospital Universitario San Pedro de Alcántara | Recruiting | Cáceres | 10003 | Spain |
| Hospital Reina Sofia | Recruiting | Córdoba | 14004 | Spain |
| Hospital Donostia | Recruiting | Donostia / San Sebastian | 20014 | Spain |
| Hospital General Universitario De Elche | Recruiting | Elche | 03203 | Spain |
| Hospital Universitario de Fuenlabrada | Recruiting | Fuenlabrada | 28942 | Spain |
| Hospital Galdakao | Recruiting | Galdakao | 48960 | Spain |
| Hospital Universitario Virgen de las Nieves | Recruiting | Granada | 18014 | Spain |
| Hospital Universitario Clínico San Cecilio | Recruiting | Granada | 18016 | Spain |
| Hospital Universitario de Jaen | Recruiting | Jaén | 23007 | Spain |
| H. León | Recruiting | León | 24008 | Spain |
| Hospital Arnau de Vilanova | Recruiting | Lleida | 25198 | Spain |
| Hospital Beata María Ana | Recruiting | Madrid | 28007 | Spain |
| Hospital General Universitario Gregorio Maranon | Recruiting | Madrid | 28007 | Spain |
| Althaia Xarxa Assistencial de Manresa | Recruiting | Manresa | 08242 | Spain |
| Hospital Universitario Virgen de la Victoria | Recruiting | Málaga | 29010 | Spain |
| Hosp. Mat-Inf. Carlos Haya | Recruiting | Málaga | 29011 | Spain |
| Hospital General Univers | Recruiting | Murcia | 30008 | Spain |
| Hospital Universitario Morales Meseguer | Withdrawn | Murcia | 30008 | Spain |
| Clínica Universidad de Navarra - Madrid | Recruiting | Pamplona | 31008 | Spain |
| Hospital Universitari Sant Joan de Reus | Recruiting | Reus | 43204 | Spain |
| Hospital Parc Tauli | Recruiting | Sabadell | 08028 | Spain |
| Hospital Universitario de Canarias | Recruiting | San Cristóbal de La Laguna | 38320 | Spain |
| HU Marqués de Valdecilla | Recruiting | Santander | 39008 | Spain |
| Hospital Universitario Virgen Macarena | Recruiting | Seville | 41009 | Spain |
| Hospital Quironsalud Sagrado Corazón | Recruiting | Seville | 41010 | Spain |
| Hospital de Toledo | Recruiting | Toledo | 45007 | Spain |
| Hospital Clínico Universitario de Valencia | Recruiting | Valencia | 46010 | Spain |
| Hospital Clínico Universitario de Valencia | Recruiting | Valencia | 46014 | Spain |
| Hospital Clinico Universitario de Valladolid | Recruiting | Valladolid | 47003 | Spain |
| Isabel la Catolica nº 1-3 | Recruiting | Zaragoza | 50009 | Spain |
| Hull University Teaching Hospitals NHS Trust | Not yet recruiting | Cottingham | HU165JQ | United Kingdom |
| The Clatterbridge Cancer Centre NHS Foundation Trust | Not yet recruiting | Liverpool | L7 8YA | United Kingdom |
| Barts Health NHS Trust | Recruiting | London | EC1M 6QB | United Kingdom |
| Guy's Hospital | Not yet recruiting | London | SE1 9RT | United Kingdom |
| Royal Marsden Hospital | Recruiting | London | SW10 9NH | United Kingdom |
| The Christie NHS Foundation Trust | Recruiting | Manchester | M20 4BX | United Kingdom |
| East and North Hertfordshire NHS Trust | Not yet recruiting | Northwood | HA6 2RN | United Kingdom |
| Taunton and Somerset NHS Foundation Trust | Recruiting | Taunton | TA1 5DA | United Kingdom |
| York Teaching Hospital NHS Foundation Trust | Not yet recruiting | York | YO31 8HE | United Kingdom |
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000608132 | sacituzumab govitecan |
| C582435 | pembrolizumab |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided