Clinical trial NCT03036488: Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-522/KEYNOTE-522)
Official title: A Phase III, Randomized, Double-blind Study to Evaluate Pembrolizumab Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy for Triple Negative Breast Cancer (TNBC)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Triple Negative Breast Neoplasms
Keywords: PD1
PD-1
PDL1
PD-L1
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2017-01-30
Enrollment: 1174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) plus chemotherapy vs placebo plus chemotherapy as neoadjuvant therapy and pembrolizumab vs placebo as adjuvant therapy in participants who have triple negative breast cancer (TNBC).

After a screening phase of approximately 28 days, each participant will receive neoadjuvant study treatment (Pembrolizumab + Chemotherapy OR Placebo + Chemotherapy) based on the randomization schedule for approximately 24 weeks (8 cycles). Each participant will then undergo definitive surgery 3-6 weeks after conclusion of the last cycle of the neoadjuvant study treatment. After definitive surgery, each participant will receive adjuvant study treatment (Pembrolizumab OR Placebo) for approximately 27 weeks (9 cycles). Following adjuvant study treatment, each participant will be monitored for safety, survival and disease recurrence.

The primary study hypothesis is that pembrolizumab is superior to placebo, in combination with chemotherapy, as measured by the rate of Pathological Complete Response (pCR) and/or Event-free Survival (EFS), in participants with locally advanced TNBC.


Eligibility criteria: Inclusion Criteria:

* Has newly diagnosed, locally advanced, centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
* Has previously untreated locally advanced non-metastatic (M0) TNBC defined as the following combined primary tumor (T) and regional lymph node (N) staging per current American Joint Committee of Cancer (AJCC) staging criteria for breast cancer as assessed by the investigator based on radiological and/or clinical assessment:

  * T1c, N1-N2
  * T2, N0-N2
  * T3, N0-N2
  * T4a-d, N0-N2
* Provides a core needle biopsy consisting of at least 2 separate tumor cores from the primary tumor at screening to the central laboratory.
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 10 days of treatment initiation.
* Demonstrates adequate organ function.
* Males and female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 12 months after the last dose of study treatment for participants who have received cyclophosphamide, and 6 months after the last dose of study treatment for participants who did not.

Exclusion Criteria:

* Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
* Has received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months.
* Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death - ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated antigen-4 \[CTLA-4\], OX-40, CD137 \[tumor necrosis factor receptor superfamily member 9 (TNFRSF9)\]) or has previously participated in a pembrolizumab (MK-3475) clinical study.
* Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 4 weeks of the first dose of treatment in this current study.
* Has received a live vaccine within 30 days of the first dose of study treatment.
* Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (i.e., dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
* Has a known history of Human Immunodeficiency Virus (HIV).
* Has known active Hepatitis B or Hepatitis C.
* Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
* Has an active infection requiring systemic therapy.
* Has significant cardiovascular disease, such as: history of myocardial infarction, acute coronary syndrome or coronary angioplasty/stenting/bypass grafting within the last 6 months OR congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV or history of CHF NYHA Class III or IV.
* Is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the screening visit through 12 months after the last dose of study treatment for participants who have received cyclophosphamide, and for 6 months after the last dose of study treatment for participants who have not.
* Has a known hypersensitivity to the components of the study treatment or its analogs.
* Has a known history of active tuberculosis (TB, Bacillus Tuberculosis).

Primary outcomes:
measure: Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery
timeFrame: Up to approximately 27-30 weeks
measure: Event-free Survival (EFS) as assessed by Investigator
timeFrame: Up to approximately 8 years
Secondary outcomes:
measure: pCR rate using an alternative definition, ypT0 ypN0 (i.e., no invasive or noninvasive residual in breast or nodes) at the time of definitive surgery
timeFrame: Up to approximately 27-30 weeks
measure: pCR rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery
timeFrame: Up to approximately 27-30 weeks
measure: EFS in participants with tumors expressing PD-L1
timeFrame: Up to approximately 8 years
measure: pCR rate using an alternative definition, ypT0/Tis (i.e., absence of invasive cancer in the breast irrespective of ductal carcinoma in situ or nodal involvement) at the time of definitive surgery
timeFrame: Up to approximately 27-30 weeks
measure: Overall survival (OS)
timeFrame: Up to approximately 8 years
measure: Percentage of participants who experience an adverse event (AE)
timeFrame: Up to approximately 61 weeks
measure: Percentage of participants who discontinue study treatment due to an AE
timeFrame: Up to approximately 57 weeks
measure: European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Core 30 Questionnaire (QLQ-C30) score
timeFrame: Up to approximately 27-30 weeks
measure: EORTC Breast Cancer-Specific QoL Questionnaire (QLQ-BR23) score
timeFrame: Up to approximately 27-30 weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Virginia G. Piper Cancer Center Pharmacy - Scottsdale Healthcare ( Site 0089)
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates PC- HOPE ( Site 8001)
state: Arizona
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center ( Site 0091)
state: California
city: Monterey
country: United States
facility: Pacific Cancer Care ( Site 0069)
state: California
city: Whittier
country: United States
facility: ICRI ( Site 0072)
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center ( Site 0021)
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine ( Site 0054)
state: Connecticut
city: Newark
country: United States
facility: Christiana Hospital ( Site 0029)
state: Delaware
city: Miami
country: United States
facility: Univ of Miami-Sylvester Comprehensive Cancer Center- Kendall satellite ( Site 0079)
state: Florida
city: Chicago
country: United States
facility: The University of Chicago Medical Center ( Site 0047)
state: Illinois
city: Evanston
country: United States
facility: North Shore University Health System ( Site 0081)
state: Illinois
city: Skokie
country: United States
facility: Orchard Healthcare Research Inc. ( Site 0049)
state: Illinois
city: Goshen
country: United States
facility: Goshen Center for Cancer Care ( Site 0010)
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospital and Clinics ( Site 0038)
state: Iowa
city: Scarborough
country: United States
facility: New England Cancer Specialists ( Site 0005)
state: Maine
city: Detroit
country: United States
facility: Henry Ford Hospital ( Site 0003)
state: Michigan
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology, PA ( Site 8013)
state: Minnesota
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey ( Site 0073)
state: New Jersey
city: Johnson City
country: United States
facility: Broome Oncology, LLC ( Site 8002)
state: New York
city: Nyack
country: United States
facility: Nyack Hospital Infusion Center ( Site 0059)
state: New York
city: Cincinnati
country: United States
facility: TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0044)
state: Ohio
city: Cincinnati
country: United States
facility: Oncology Hematology Care, Inc. ( Site 8011)
state: Ohio
city: Portland
country: United States
facility: Providence Portland Medical Center ( Site 0052)
state: Oregon
city: Portland
country: United States
facility: Northwest Cancer Specialists, P.C. ( Site 8008)
state: Oregon
city: Pittsburgh
country: United States
facility: Magee - Women's Hospital ( Site 0011)
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital ( Site 0060)
state: Rhode Island
city: Germantown
country: United States
facility: The West Clinic, P.C. ( Site 0078)
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology-Austin Central ( Site 8005)
state: Texas
city: Dallas
country: United States
facility: Parkland Health and Hospital System ( Site 0093)
state: Texas
city: Dallas
country: United States
facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 8006)
state: Texas
city: Dallas
country: United States
facility: Simmons Cancer Center ( Site 0094)
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center ( Site 0030)
state: Texas
city: Fort Worth
country: United States
facility: Moncrief Cancer Institute ( Site 0092)
state: Texas
city: Houston
country: United States
facility: Texas Oncology-Memorial City ( Site 8003)
state: Texas
city: Houston
country: United States
facility: Houston Methodist Cancer Center ( Site 0013)
state: Texas
city: Plano
country: United States
facility: Texas Oncology- Plano East ( Site 8010)
state: Texas
city: San Antonio
country: United States
facility: Texas Oncology-San Antonio Northeast ( Site 8012)
state: Texas
city: Tyler
country: United States
facility: Texas Oncology-Tyler ( Site 8007)
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia ( Site 0022)
state: Virginia
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, PC ( Site 8009)
state: Virginia
city: Midlothian
country: United States
facility: Bon Secours Cancer Institute Medical Oncology at St. Mary's ( Site 0033)
state: Virginia
city: Newport News
country: United States
facility: Peninsula Cancer Institute, LLC ( Site 0041)
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates ( Site 8000)
state: Virginia
city: Kennewick
country: United States
facility: Kadlec Clinic Hematology and Oncology ( Site 0087)
state: Washington
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance ( Site 0068)
state: Washington
city: Spokane
country: United States
facility: Medical Oncology Associates (Summit Cancer Centers) ( Site 0014)
state: Washington
city: Yakima
country: United States
facility: YVMH dba Vrigina Mason Memorial/North Star Lodge Cancer Center ( Site 8004)
state: Washington
city: Sydney
country: Australia
facility: Royal North Shore Hospital ( Site 2000)
state: New South Wales
city: Sydney
country: Australia
facility: Westmead Hospital ( Site 2002)
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital ( Site 2008)
state: South Australia
city: East Malvern
country: Australia
facility: Cabrini Health ( Site 2009)
state: Victoria
city: Franskton
country: Australia
facility: Frankston Hospital ( Site 2010)
city: Herston
country: Australia
facility: Royal Brisbane and Women s Hospital ( Site 2003)
city: Perth
country: Australia
facility: St John of God Subiaco Hospital ( Site 2006)
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao ( Site 0203)
state: Rio Grande Do Sul
city: Cascavel
country: Brazil
facility: UOPECCAN - Uniao Oeste Paranaense de Estudos e Combate ao Cancer ( Site 0206)
city: Caxias do Sul
country: Brazil
facility: Universidade de Caxias do Sul ( Site 0201)
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner ( Site 0207)
city: Fortaleza
country: Brazil
facility: Instituto do Cancer do Ceara ( Site 0205)
city: Goiania
country: Brazil
facility: Hospital Araujo Jorge ( Site 0204)
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas da PUCRS ( Site 0200)
city: Sao Jose do Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto ( Site 0208)
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer de Sao Paulo - ICESP ( Site 0211)
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre ( Site 0105)
state: Alberta
city: Ottawa
country: Canada
facility: The Ottawa Hospital - Cancer Care ( Site 0100)
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre ( Site 0103)
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0106)
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital ( Site 0101)
state: Quebec
city: Sherbrooke
country: Canada
facility: CIUSSS de l'Estrie-CHUS ( Site 0102)
state: Quebec
city: Quebec
country: Canada
facility: CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0104)
city: Monteria
country: Colombia
facility: Oncomedica S.A. ( Site 0404)
state: Cordoba
city: Pereira
country: Colombia
facility: Oncologos del Occidente S.A. ( Site 0405)
state: Risaralda
city: Bogota
country: Colombia
facility: Hospital Universitario San Ignacio ( Site 0401)
city: Bogota
country: Colombia
facility: Instituto Nacional de Cancerologia [Bogota-Colombia] ( Site 0403)
city: Cali
country: Colombia
facility: Hemato Oncologos S.A. ( Site 0400)
city: Medellin
country: Colombia
facility: Instituto De Cancerologia S.A. ( Site 0406)
city: Besancon
country: France
facility: CHU Jean Minjoz ( Site 0917)
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine ( Site 0911)
city: Caen
country: France
facility: Centre Francois Baclesse ( Site 0907)
city: Clermont-Ferrand Cedex 01
country: France
facility: Centre Jean Perrin ( Site 0903)
city: Le Mans
country: France
facility: Clinique Victor Hugo ( Site 0901)
city: Nantes
country: France
facility: Hopital prive du Confluent ( Site 0902)
city: Paris
country: France
facility: Institut Curie ( Site 0909)
city: Paris
country: France
facility: Hopital Saint Louis ( Site 0908)
city: Paris
country: France
facility: Hopital Diaconesses Croix Saint Simon ( Site 0905)
city: Poitiers
country: France
facility: CHU de la Miletrie Poitiers ( Site 0913)
city: Toulouse Cedex 9
country: France
facility: Institut Claudius Regaud IUCT Oncopole ( Site 0914)
city: Berlin
country: Germany
facility: HELIOS Klinikum Berlin-Buch ( Site 1005)
city: Bonn
country: Germany
facility: Gynaekologisches Zentrum ( Site 1004)
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen ( Site 1001)
city: Essen
country: Germany
facility: Kliniken Essen Mitte ( Site 1012)
city: Halle
country: Germany
facility: Universitaetsklinik und Poliklinik Halle/Saale ( Site 1008)
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf ( Site 1007)
city: Muenchen
country: Germany
facility: Klinikum der Universit. Muenchen ( Site 1002)
city: Saarbruecken
country: Germany
facility: Caritasklinik St. Theresia ( Site 1011)
city: Tubingen
country: Germany
facility: Universitaets-Frauenklinik Tuebingen ( Site 1003)
city: Cork
country: Ireland
facility: Bon Secours Hospital ( Site 1551)
city: Dublin
country: Ireland
facility: St Vincents University Hospital ( Site 1550)
city: Beer Sheva
country: Israel
facility: Oncology institute ( Site 1601)
city: Beer Yaakov-Zerifin
country: Israel
facility: Assaf Harofeh MC ( Site 1605)
city: Jerusalem
country: Israel
facility: Hadassah Ein Karem - Sharett Institute of Oncology ( Site 1600)
city: Petah Tikva
country: Israel
facility: Rabin-Medical Center ( Site 1604)
city: Ramat-Gan
country: Israel
facility: Sheba Medical Center ( Site 1602)
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center ( Site 1603)
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 1101)
state: FC
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia ( Site 1103)
city: Lucca
country: Italy
facility: Ospedale San Luca, AZIENDA USL2 TOSCANA NORD OVEST ( Site 1105)
city: Macerata
country: Italy
facility: Ospedale Civile di Macerata ( Site 1104)
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia ( Site 1106)
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1102)
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital ( Site 2502)
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 2518)
state: Chiba
city: Sapporo
country: Japan
facility: National Hospital Organization Hokkaido Cancer Center ( Site 2512)
state: Hokkaido
city: Nishinomiya
country: Japan
facility: Hyogo College of Medicine Hospital ( Site 2506)
state: Hyogo
city: Isehara
country: Japan
facility: Tokai University Hospital ( Site 2517)
state: Kanagawa
city: Kawasaki
country: Japan
facility: St. Marianna University School of Medicine Hospital ( Site 2516)
state: Kanagawa
city: Osakasayama
country: Japan
facility: Kindai University Hospital ( Site 2507)
state: Osaka
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center ( Site 2513)
state: Saitama
city: Kitaadachi-gun
country: Japan
facility: Saitama Cancer Center ( Site 2510)
state: Saitama
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 2514)
state: Shizuoka
city: Chiba
country: Japan
facility: Chiba Cancer Center ( Site 2519)
city: Hiroshima
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital ( Site 2501)
city: Kagoshima
country: Japan
facility: Social medical corporation Hakuaikai Sagara Hospital ( Site 2508)
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital ( Site 2515)
city: Osaka
country: Japan
facility: National Hospital Organization Osaka National Hospital ( Site 2505)
city: Tokyo
country: Japan
facility: National Cancer Center Hospital ( Site 2500)
city: Tokyo
country: Japan
facility: St.Luke's International Hospital ( Site 2511)
city: Tokyo
country: Japan
facility: Toranomon Hospital ( Site 2503)
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR ( Site 2509)
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 2101)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System ( Site 2100)
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center ( Site 2102)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 2103)
city: Wieliszew
country: Poland
facility: Mazowiecki Szpital Onkologiczny ( Site 1713)
state: Mazowieckie
city: Gliwice
country: Poland
facility: Centrum Onkologii Instytut im. Marii Skłodowskiej Curie ( Site 1717)
state: Slaskie
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1708)
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1712)
city: Gdynia
country: Poland
facility: Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1701)
city: Krakow
country: Poland
facility: Centrum Onkologii Instytut im. Marii Sklodowskiej Curie ( Site 1719)
city: Lublin
country: Poland
facility: Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli ( Site 1700)
city: Wroclaw
country: Poland
facility: Dolnoslaskie Centrum Onkologii. ( Site 1702)
city: Lisboa
country: Portugal
facility: Fundacao Champalimaud ( Site 2444)
city: Lisboa
country: Portugal
facility: Hospital de Santa Maria, E.P.E. ( Site 2445)
city: Porto
country: Portugal
facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 2446)
city: Arkhangelsk
country: Russian Federation
facility: Arkhangelsk Clinical Oncological Dispensary ( Site 1810)
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1805)
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1806)
city: Moscow
country: Russian Federation
facility: Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 1801)
city: Ryazan
country: Russian Federation
facility: GBU RO Regional Clinical Oncological Dispensary ( Site 1808)
city: Saint Petersburg
country: Russian Federation
facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1803)
city: Ufa
country: Russian Federation
facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1804)
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore ( Site 2600)
city: Hospitalet de Llobregat
country: Spain
facility: ICO L Hospitalet ( Site 1305)
state: Barcelona
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Quiron de Madrid ( Site 1303)
state: Madrid
city: Barcelona
country: Spain
facility: Hospital del Mar ( Site 1306)
city: Barcelona
country: Spain
facility: Instituto Oncologico Baselga.Hospital Quiron. ( Site 1312)
city: Barcelona
country: Spain
facility: Hospital General Universitari Vall d Hebron ( Site 1301)
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia ( Site 1304)
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal ( Site 1300)
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago ( Site 1308)
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio ( Site 1314)
city: Valencia
country: Spain
facility: Hospital Clinico Univ de Valencia ( Site 1313)
city: Linkoping
country: Sweden
facility: Linkopings Universitetssjukhus ( Site 1402)
city: Solna
country: Sweden
facility: Karolinska Universitetssjukhuset Solna ( Site 1404)
city: Umea
country: Sweden
facility: Norrlands Universitetssjukhus ( Site 1401)
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset ( Site 1403)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital ( Site 2302)
state: Beitou
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 2305)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 2301)
city: Taipei
country: Taiwan
facility: MacKay Memorial Hospital ( Site 2303)
city: Taipei
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center ( Site 2304)
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital ( Site 2300)
city: Samsun
country: Turkey
facility: Samsun Ondokuz Mayıs Universitesi Tıp Fakultesi Hastanesi ( Site 1910)
state: Atakum
city: Adana
country: Turkey
facility: Adana Acıbadem Hospital Department of Medical Oncology ( Site 1906)
city: Adana
country: Turkey
facility: Baskent Unıversity Adana Kısla Hospital ( Site 1903)
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1912)
city: Ankara
country: Turkey
facility: Abdurrahman Yurtaslan Oncology Training and Research Hospital ( Site 1909)
city: Ankara
country: Turkey
facility: Ozel Medicana International Ankara Hastanesi ( Site 1915)
city: Antalya
country: Turkey
facility: Antalya Memorial Hospital Department of Medical Oncology ( Site 1908)
city: Edirne
country: Turkey
facility: Trakya University Medical Faculty Balkan Oncology Hospital ( Site 1901)
city: Istambul
country: Turkey
facility: Acibadem Altunizade Hastanesi ( Site 1900)
city: Istanbul
country: Turkey
facility: İstanbul University Cerrahpaşa Medical Faculty ( Site 1904)
city: Istanbul
country: Turkey
facility: Amerikan Hospital Medical ( Site 1902)
city: Istanbul
country: Turkey
facility: Memorial Sisli Hastanesi ( Site 1913)
city: Izmir
country: Turkey
facility: Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 1905)
city: Izmir
country: Turkey
facility: Izmir Medical Park Hospital Department of Medical Oncology ( Site 1907)
city: Colchester
country: United Kingdom
facility: Colchester General Hospital ( Site 1508)
state: Essex
city: London
country: United Kingdom
facility: Barts Cancer Institute ( Site 1500)
city: London
country: United Kingdom
facility: St George s Hospital ( Site 1516)
city: Maidstone
country: United Kingdom
facility: Maidstone Hospital ( Site 1511)
city: Middlesbrough
country: United Kingdom
facility: The James Cook University Hospital ( Site 1515)
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust ( Site 1505)
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospitals NHS Trust ( Site 1504)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Schmid P, Cortes J, Dent R, McArthur H, Pusztai L, Kummel S, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Im SA, Untch M, Fasching PA, Mouret-Reynier MA, Foukakis T, Ferreira M, Cardoso F, Zhou X, Karantza V, Tryfonidis K, Aktan G, O'Shaughnessy J; KEYNOTE-522 Investigators. Overall Survival with Pembrolizumab in Early-Stage Triple-Negative Breast Cancer. N Engl J Med. 2024 Nov 28;391(21):1981-1991. doi: 10.1056/NEJMoa2409932. Epub 2024 Sep 15.
citation: Schmid P, Cortes J, Dent R, Pusztai L, McArthur H, Kummel S, Bergh J, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Untch M, Fasching PA, Cardoso F, Andersen J, Patt D, Danso M, Ferreira M, Mouret-Reynier MA, Im SA, Ahn JH, Gion M, Baron-Hay S, Boileau JF, Ding Y, Tryfonidis K, Aktan G, Karantza V, O'Shaughnessy J; KEYNOTE-522 Investigators. Event-free Survival with Pembrolizumab in Early Triple-Negative Breast Cancer. N Engl J Med. 2022 Feb 10;386(6):556-567. doi: 10.1056/NEJMoa2112651.
citation: Perez-Garcia J, Soberino J, Racca F, Gion M, Stradella A, Cortes J. Atezolizumab in the treatment of metastatic triple-negative breast cancer. Expert Opin Biol Ther. 2020 Sep;20(9):981-989. doi: 10.1080/14712598.2020.1769063. Epub 2020 May 25.
citation: Schmid P, Cortes J, Pusztai L, McArthur H, Kummel S, Bergh J, Denkert C, Park YH, Hui R, Harbeck N, Takahashi M, Foukakis T, Fasching PA, Cardoso F, Untch M, Jia L, Karantza V, Zhao J, Aktan G, Dent R, O'Shaughnessy J; KEYNOTE-522 Investigators. Pembrolizumab for Early Triple-Negative Breast Cancer. N Engl J Med. 2020 Feb 27;382(9):810-821. doi: 10.1056/NEJMoa1910549.