Breast Cancer Clinical Trial

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)

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.

View Eligibility Criteria

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).

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

1174

Study ID:

NCT03036488

Recruitment Status:

Active, not recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 190 Locations for this study

See Locations Near You

Virginia G. Piper Cancer Center Pharmacy - Scottsdale Healthcare ( Site 0089)
Scottsdale Arizona, 85268, United States
Arizona Oncology Associates PC- HOPE ( Site 8001)
Tucson Arizona, 85711, United States
Cedars Sinai Medical Center ( Site 0091)
Los Angeles California, 90048, United States
Pacific Cancer Care ( Site 0069)
Monterey California, 93940, United States
ICRI ( Site 0072)
Whittier California, 90603, United States
University of Colorado Cancer Center ( Site 0021)
Aurora Colorado, 80045, United States
Yale University School of Medicine ( Site 0054)
New Haven Connecticut, 06510, United States
Christiana Hospital ( Site 0029)
Newark Delaware, 19713, United States
Univ of Miami-Sylvester Comprehensive Cancer Center- Kendall satellite ( Site 0079)
Miami Florida, 33176, United States
The University of Chicago Medical Center ( Site 0047)
Chicago Illinois, 60637, United States
North Shore University Health System ( Site 0081)
Evanston Illinois, 60201, United States
Orchard Healthcare Research Inc. ( Site 0049)
Skokie Illinois, 60077, United States
Goshen Center for Cancer Care ( Site 0010)
Goshen Indiana, 46526, United States
University of Iowa Hospital and Clinics ( Site 0038)
Iowa City Iowa, 52242, United States
New England Cancer Specialists ( Site 0005)
Scarborough Maine, 04074, United States
Henry Ford Hospital ( Site 0003)
Detroit Michigan, 48202, United States
Minnesota Oncology Hematology, PA ( Site 8013)
Minneapolis Minnesota, 55404, United States
Rutgers Cancer Institute of New Jersey ( Site 0073)
New Brunswick New Jersey, 08903, United States
Broome Oncology, LLC ( Site 8002)
Johnson City New York, 13790, United States
Nyack Hospital Infusion Center ( Site 0059)
Nyack New York, 10960, United States
TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0044)
Cincinnati Ohio, 45220, United States
Oncology Hematology Care, Inc. ( Site 8011)
Cincinnati Ohio, 45242, United States
Providence Portland Medical Center ( Site 0052)
Portland Oregon, 97213, United States
Northwest Cancer Specialists, P.C. ( Site 8008)
Portland Oregon, 97227, United States
Magee - Women's Hospital ( Site 0011)
Pittsburgh Pennsylvania, 15213, United States
Rhode Island Hospital ( Site 0060)
Providence Rhode Island, 02903, United States
The West Clinic, P.C. ( Site 0078)
Germantown Tennessee, 38138, United States
Texas Oncology-Austin Central ( Site 8005)
Austin Texas, 78731, United States
Parkland Health and Hospital System ( Site 0093)
Dallas Texas, 75235, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 8006)
Dallas Texas, 75246, United States
Simmons Cancer Center ( Site 0094)
Dallas Texas, 75390, United States
UT Southwestern Medical Center ( Site 0030)
Dallas Texas, 75390, United States
Moncrief Cancer Institute ( Site 0092)
Fort Worth Texas, 76104, United States
Texas Oncology-Memorial City ( Site 8003)
Houston Texas, 77024, United States
Houston Methodist Cancer Center ( Site 0013)
Houston Texas, 77030, United States
Texas Oncology- Plano East ( Site 8010)
Plano Texas, 75075, United States
Texas Oncology-San Antonio Northeast ( Site 8012)
San Antonio Texas, 78217, United States
Texas Oncology-Tyler ( Site 8007)
Tyler Texas, 75702, United States
University of Virginia ( Site 0022)
Charlottesville Virginia, 22903, United States
Virginia Cancer Specialists, PC ( Site 8009)
Fairfax Virginia, 22031, United States
Bon Secours Cancer Institute Medical Oncology at St. Mary's ( Site 0033)
Midlothian Virginia, 23114, United States
Peninsula Cancer Institute, LLC ( Site 0041)
Newport News Virginia, 23601, United States
Virginia Oncology Associates ( Site 8000)
Norfolk Virginia, 23502, United States
Kadlec Clinic Hematology and Oncology ( Site 0087)
Kennewick Washington, 99336, United States
Seattle Cancer Care Alliance ( Site 0068)
Seattle Washington, 98109, United States
Medical Oncology Associates (Summit Cancer Centers) ( Site 0014)
Spokane Washington, 99208, United States
YVMH dba Vrigina Mason Memorial/North Star Lodge Cancer Center ( Site 8004)
Yakima Washington, 98902, United States
Royal North Shore Hospital ( Site 2000)
Sydney New South Wales, 2065, Australia
Westmead Hospital ( Site 2002)
Sydney New South Wales, 2145, Australia
Royal Adelaide Hospital ( Site 2008)
Adelaide South Australia, 5000, Australia
Cabrini Health ( Site 2009)
East Malvern Victoria, 3145, Australia
Frankston Hospital ( Site 2010)
Franskton , 3199, Australia
Royal Brisbane and Women s Hospital ( Site 2003)
Herston , 4029, Australia
St John of God Subiaco Hospital ( Site 2006)
Perth , 6008, Australia
Hospital Nossa Senhora da Conceicao ( Site 0203)
Porto Alegre Rio Grande Do Sul, 91350, Brazil
UOPECCAN - Uniao Oeste Paranaense de Estudos e Combate ao Cancer ( Site 0206)
Cascavel , 85806, Brazil
Universidade de Caxias do Sul ( Site 0201)
Caxias do Sul , 95070, Brazil
Hospital Erasto Gaertner ( Site 0207)
Curitiba , 81520, Brazil
Instituto do Cancer do Ceara ( Site 0205)
Fortaleza , 60430, Brazil
Hospital Araujo Jorge ( Site 0204)
Goiania , 74605, Brazil
Hospital Sao Lucas da PUCRS ( Site 0200)
Porto Alegre , 90610, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto ( Site 0208)
Sao Jose do Rio Preto , 15090, Brazil
Instituto do Cancer de Sao Paulo - ICESP ( Site 0211)
Sao Paulo , 01246, Brazil
Tom Baker Cancer Centre ( Site 0105)
Calgary Alberta, T2N 4, Canada
The Ottawa Hospital - Cancer Care ( Site 0100)
Ottawa Ontario, K1H 8, Canada
Princess Margaret Cancer Centre ( Site 0103)
Toronto Ontario, M5G 2, Canada
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0106)
Montreal Quebec, H2X 0, Canada
Jewish General Hospital ( Site 0101)
Montreal Quebec, H3T 1, Canada
CIUSSS de l'Estrie-CHUS ( Site 0102)
Sherbrooke Quebec, J1H 5, Canada
CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0104)
Quebec , G1S 4, Canada
Oncomedica S.A. ( Site 0404)
Monteria Cordoba, 23000, Colombia
Oncologos del Occidente S.A. ( Site 0405)
Pereira Risaralda, 66100, Colombia
Hospital Universitario San Ignacio ( Site 0401)
Bogota , 11023, Colombia
Instituto Nacional de Cancerologia [Bogota-Colombia] ( Site 0403)
Bogota , 11041, Colombia
Hemato Oncologos S.A. ( Site 0400)
Cali , 76000, Colombia
Instituto De Cancerologia S.A. ( Site 0406)
Medellin , 05002, Colombia
CHU Jean Minjoz ( Site 0917)
Besancon , 25000, France
Polyclinique Bordeaux Nord Aquitaine ( Site 0911)
Bordeaux , 33077, France
Centre Francois Baclesse ( Site 0907)
Caen , 14000, France
Centre Jean Perrin ( Site 0903)
Clermont-Ferrand Cedex 01 , 63001, France
Clinique Victor Hugo ( Site 0901)
Le Mans , 72015, France
Hopital prive du Confluent ( Site 0902)
Nantes , 44277, France
Institut Curie ( Site 0909)
Paris , 75005, France
Hopital Saint Louis ( Site 0908)
Paris , 75010, France
Hopital Diaconesses Croix Saint Simon ( Site 0905)
Paris , 75020, France
CHU de la Miletrie Poitiers ( Site 0913)
Poitiers , 86021, France
Institut Claudius Regaud IUCT Oncopole ( Site 0914)
Toulouse Cedex 9 , 31059, France
HELIOS Klinikum Berlin-Buch ( Site 1005)
Berlin , 13125, Germany
Gynaekologisches Zentrum ( Site 1004)
Bonn , 53111, Germany
Universitaetsklinikum Erlangen ( Site 1001)
Erlangen , 91054, Germany
Kliniken Essen Mitte ( Site 1012)
Essen , 45136, Germany
Universitaetsklinik und Poliklinik Halle/Saale ( Site 1008)
Halle , 06120, Germany
Universitaetsklinikum Hamburg-Eppendorf ( Site 1007)
Hamburg , 20246, Germany
Klinikum der Universit. Muenchen ( Site 1002)
Muenchen , 80337, Germany
Caritasklinik St. Theresia ( Site 1011)
Saarbruecken , 66113, Germany
Universitaets-Frauenklinik Tuebingen ( Site 1003)
Tubingen , 72076, Germany
Bon Secours Hospital ( Site 1551)
Cork , T12 D, Ireland
St Vincents University Hospital ( Site 1550)
Dublin , D04 T, Ireland
Oncology institute ( Site 1601)
Beer Sheva , 84101, Israel
Assaf Harofeh MC ( Site 1605)
Beer Yaakov-Zerifin , 70300, Israel
Hadassah Ein Karem - Sharett Institute of Oncology ( Site 1600)
Jerusalem , 91120, Israel
Rabin-Medical Center ( Site 1604)
Petah Tikva , 49414, Israel
Sheba Medical Center ( Site 1602)
Ramat-Gan , 52656, Israel
Sourasky Medical Center ( Site 1603)
Tel Aviv , 64239, Israel
Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 1101)
Meldola FC, 47014, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia ( Site 1103)
Brescia , 25100, Italy
Ospedale San Luca, AZIENDA USL2 TOSCANA NORD OVEST ( Site 1105)
Lucca , 55100, Italy
Ospedale Civile di Macerata ( Site 1104)
Macerata , 62100, Italy
Istituto Europeo di Oncologia ( Site 1106)
Milano , 20141, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1102)
Napoli , 80131, Italy
Aichi Cancer Center Hospital ( Site 2502)
Nagoya Aichi, 464-8, Japan
National Cancer Center Hospital East ( Site 2518)
Kashiwa Chiba, 277-8, Japan
National Hospital Organization Hokkaido Cancer Center ( Site 2512)
Sapporo Hokkaido, 003-0, Japan
Hyogo College of Medicine Hospital ( Site 2506)
Nishinomiya Hyogo, 663-8, Japan
Tokai University Hospital ( Site 2517)
Isehara Kanagawa, 259-1, Japan
St. Marianna University School of Medicine Hospital ( Site 2516)
Kawasaki Kanagawa, 216-8, Japan
Kindai University Hospital ( Site 2507)
Osakasayama Osaka, 589-8, Japan
Saitama Medical University International Medical Center ( Site 2513)
Hidaka Saitama, 350-1, Japan
Saitama Cancer Center ( Site 2510)
Kitaadachi-gun Saitama, 362-0, Japan
Shizuoka Cancer Center Hospital and Research Institute ( Site 2514)
Sunto-gun Shizuoka, 411-8, Japan
Chiba Cancer Center ( Site 2519)
Chiba , 260-8, Japan
Hiroshima City Hiroshima Citizens Hospital ( Site 2501)
Hiroshima , 730-8, Japan
Social medical corporation Hakuaikai Sagara Hospital ( Site 2508)
Kagoshima , 892-0, Japan
Kumamoto University Hospital ( Site 2515)
Kumamoto , 860-8, Japan
National Hospital Organization Osaka National Hospital ( Site 2505)
Osaka , 540-0, Japan
National Cancer Center Hospital ( Site 2500)
Tokyo , 104-0, Japan
St.Luke's International Hospital ( Site 2511)
Tokyo , 104-8, Japan
Toranomon Hospital ( Site 2503)
Tokyo , 105-8, Japan
The Cancer Institute Hospital of JFCR ( Site 2509)
Tokyo , 135-8, Japan
Seoul National University Hospital ( Site 2101)
Seoul , 03080, Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 2100)
Seoul , 03722, Korea, Republic of
Asan Medical Center ( Site 2102)
Seoul , 05505, Korea, Republic of
Samsung Medical Center ( Site 2103)
Seoul , 06351, Korea, Republic of
Mazowiecki Szpital Onkologiczny ( Site 1713)
Wieliszew Mazowieckie, 05-13, Poland
Centrum Onkologii Instytut im. Marii Skłodowskiej Curie ( Site 1717)
Gliwice Slaskie, 44-10, Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1708)
Bydgoszcz , 85-79, Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1712)
Bydgoszcz , 85-79, Poland
Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1701)
Gdynia , 81-51, Poland
Centrum Onkologii Instytut im. Marii Sklodowskiej Curie ( Site 1719)
Krakow , 31-11, Poland
Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli ( Site 1700)
Lublin , 20-09, Poland
Dolnoslaskie Centrum Onkologii. ( Site 1702)
Wroclaw , 53-41, Poland
Fundacao Champalimaud ( Site 2444)
Lisboa , 1400-, Portugal
Hospital de Santa Maria, E.P.E. ( Site 2445)
Lisboa , 1600-, Portugal
Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 2446)
Porto , 4200-, Portugal
Arkhangelsk Clinical Oncological Dispensary ( Site 1810)
Arkhangelsk , 16304, Russian Federation
Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1805)
Chelyabinsk , 45408, Russian Federation
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1806)
Kazan , 42002, Russian Federation
Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 1801)
Moscow , 11547, Russian Federation
GBU RO Regional Clinical Oncological Dispensary ( Site 1808)
Ryazan , 39004, Russian Federation
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1803)
Saint Petersburg , 19775, Russian Federation
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1804)
Ufa , 45005, Russian Federation
National Cancer Centre Singapore ( Site 2600)
Singapore , 16961, Singapore
ICO L Hospitalet ( Site 1305)
Hospitalet de Llobregat Barcelona, 08908, Spain
Hospital Quiron de Madrid ( Site 1303)
Pozuelo de Alarcon Madrid, 28223, Spain
Hospital del Mar ( Site 1306)
Barcelona , 08003, Spain
Instituto Oncologico Baselga.Hospital Quiron. ( Site 1312)
Barcelona , 08023, Spain
Hospital General Universitari Vall d Hebron ( Site 1301)
Barcelona , 08035, Spain
Hospital Universitario Reina Sofia ( Site 1304)
Cordoba , 14004, Spain
Hospital Universitario Ramon y Cajal ( Site 1300)
Madrid , 28034, Spain
Complejo Hospitalario Universitario de Santiago ( Site 1308)
Santiago de Compostela , 15706, Spain
Hospital Universitario Virgen del Rocio ( Site 1314)
Sevilla , 41013, Spain
Hospital Clinico Univ de Valencia ( Site 1313)
Valencia , 46011, Spain
Linkopings Universitetssjukhus ( Site 1402)
Linkoping , 581 8, Sweden
Karolinska Universitetssjukhuset Solna ( Site 1404)
Solna , 171 6, Sweden
Norrlands Universitetssjukhus ( Site 1401)
Umea , 901 8, Sweden
Akademiska Sjukhuset ( Site 1403)
Uppsala , 751 8, Sweden
Taipei Veterans General Hospital ( Site 2302)
Taipei Beitou, 11217, Taiwan
National Cheng Kung University Hospital ( Site 2305)
Tainan , 704, Taiwan
National Taiwan University Hospital ( Site 2301)
Taipei , 100, Taiwan
MacKay Memorial Hospital ( Site 2303)
Taipei , 105, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center ( Site 2304)
Taipei , 11259, Taiwan
Linkou Chang Gung Memorial Hospital ( Site 2300)
Taoyuan , 333, Taiwan
Samsun Ondokuz Mayıs Universitesi Tıp Fakultesi Hastanesi ( Site 1910)
Samsun Atakum, 55280, Turkey
Adana Acıbadem Hospital Department of Medical Oncology ( Site 1906)
Adana , 01130, Turkey
Baskent Unıversity Adana Kısla Hospital ( Site 1903)
Adana , 01250, Turkey
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1912)
Ankara , 06100, Turkey
Abdurrahman Yurtaslan Oncology Training and Research Hospital ( Site 1909)
Ankara , 06200, Turkey
Ozel Medicana International Ankara Hastanesi ( Site 1915)
Ankara , 06510, Turkey
Antalya Memorial Hospital Department of Medical Oncology ( Site 1908)
Antalya , 07020, Turkey
Trakya University Medical Faculty Balkan Oncology Hospital ( Site 1901)
Edirne , 22030, Turkey
Acibadem Altunizade Hastanesi ( Site 1900)
Istambul , 34662, Turkey
İstanbul University Cerrahpaşa Medical Faculty ( Site 1904)
Istanbul , 34098, Turkey
Amerikan Hospital Medical ( Site 1902)
Istanbul , 34365, Turkey
Memorial Sisli Hastanesi ( Site 1913)
Istanbul , 34384, Turkey
Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 1905)
Izmir , 35040, Turkey
Izmir Medical Park Hospital Department of Medical Oncology ( Site 1907)
Izmir , 35575, Turkey
Colchester General Hospital ( Site 1508)
Colchester Essex, CO4 5, United Kingdom
Barts Cancer Institute ( Site 1500)
London , EC1M , United Kingdom
St George s Hospital ( Site 1516)
London , SW17 , United Kingdom
Maidstone Hospital ( Site 1511)
Maidstone , ME16 , United Kingdom
The James Cook University Hospital ( Site 1515)
Middlesbrough , TS4 3, United Kingdom
Nottingham University Hospitals NHS Trust ( Site 1505)
Nottingham , NG5 1, United Kingdom
Royal Cornwall Hospitals NHS Trust ( Site 1504)
Truro , TR1 3, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

1174

Study ID:

NCT03036488

Recruitment Status:

Active, not recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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