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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)

Primary Purpose

Triple Negative Breast Neoplasms

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab
Carboplatin
Paclitaxel
Doxorubicin
Epirubicin
Cyclophosphamide
Placebo
Granulocyte colony stimulating factor: Filgrastim or Pegfilgastrim
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Triple Negative Breast Neoplasms focused on measuring PD1, PD-1, PDL1, PD-L1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Virginia G. Piper Cancer Center Pharmacy - Scottsdale Healthcare ( Site 0089)
  • Arizona Oncology Associates PC- HOPE ( Site 8001)
  • Cedars Sinai Medical Center ( Site 0091)
  • Pacific Cancer Care ( Site 0069)
  • ICRI ( Site 0072)
  • University of Colorado Cancer Center ( Site 0021)
  • Yale University School of Medicine ( Site 0054)
  • Christiana Hospital ( Site 0029)
  • Univ of Miami-Sylvester Comprehensive Cancer Center- Kendall satellite ( Site 0079)
  • The University of Chicago Medical Center ( Site 0047)
  • North Shore University Health System ( Site 0081)
  • Orchard Healthcare Research Inc. ( Site 0049)
  • Goshen Center for Cancer Care ( Site 0010)
  • University of Iowa Hospital and Clinics ( Site 0038)
  • New England Cancer Specialists ( Site 0005)
  • Henry Ford Hospital ( Site 0003)
  • Minnesota Oncology Hematology, PA ( Site 8013)
  • Rutgers Cancer Institute of New Jersey ( Site 0073)
  • Broome Oncology, LLC ( Site 8002)
  • Nyack Hospital Infusion Center ( Site 0059)
  • TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0044)
  • Oncology Hematology Care, Inc. ( Site 8011)
  • Providence Portland Medical Center ( Site 0052)
  • Northwest Cancer Specialists, P.C. ( Site 8008)
  • Magee - Women's Hospital ( Site 0011)
  • Rhode Island Hospital ( Site 0060)
  • The West Clinic, P.C. ( Site 0078)
  • Texas Oncology-Austin Central ( Site 8005)
  • Parkland Health and Hospital System ( Site 0093)
  • Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 8006)
  • Simmons Cancer Center ( Site 0094)
  • UT Southwestern Medical Center ( Site 0030)
  • Moncrief Cancer Institute ( Site 0092)
  • Texas Oncology-Memorial City ( Site 8003)
  • Houston Methodist Cancer Center ( Site 0013)
  • Texas Oncology- Plano East ( Site 8010)
  • Texas Oncology-San Antonio Northeast ( Site 8012)
  • Texas Oncology-Tyler ( Site 8007)
  • University of Virginia ( Site 0022)
  • Virginia Cancer Specialists, PC ( Site 8009)
  • Bon Secours Cancer Institute Medical Oncology at St. Mary's ( Site 0033)
  • Peninsula Cancer Institute, LLC ( Site 0041)
  • Virginia Oncology Associates ( Site 8000)
  • Kadlec Clinic Hematology and Oncology ( Site 0087)
  • Seattle Cancer Care Alliance ( Site 0068)
  • Medical Oncology Associates (Summit Cancer Centers) ( Site 0014)
  • YVMH dba Vrigina Mason Memorial/North Star Lodge Cancer Center ( Site 8004)
  • Royal North Shore Hospital ( Site 2000)
  • Westmead Hospital ( Site 2002)
  • Royal Adelaide Hospital ( Site 2008)
  • Cabrini Health ( Site 2009)
  • Frankston Hospital ( Site 2010)
  • Royal Brisbane and Women s Hospital ( Site 2003)
  • St John of God Subiaco Hospital ( Site 2006)
  • Hospital Nossa Senhora da Conceicao ( Site 0203)
  • UOPECCAN - Uniao Oeste Paranaense de Estudos e Combate ao Cancer ( Site 0206)
  • Universidade de Caxias do Sul ( Site 0201)
  • Hospital Erasto Gaertner ( Site 0207)
  • Instituto do Cancer do Ceara ( Site 0205)
  • Hospital Araujo Jorge ( Site 0204)
  • Hospital Sao Lucas da PUCRS ( Site 0200)
  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto ( Site 0208)
  • Instituto do Cancer de Sao Paulo - ICESP ( Site 0211)
  • Tom Baker Cancer Centre ( Site 0105)
  • The Ottawa Hospital - Cancer Care ( Site 0100)
  • Princess Margaret Cancer Centre ( Site 0103)
  • Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0106)
  • Jewish General Hospital ( Site 0101)
  • CIUSSS de l'Estrie-CHUS ( Site 0102)
  • CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0104)
  • Oncomedica S.A. ( Site 0404)
  • Oncologos del Occidente S.A. ( Site 0405)
  • Hospital Universitario San Ignacio ( Site 0401)
  • Instituto Nacional de Cancerologia [Bogota-Colombia] ( Site 0403)
  • Hemato Oncologos S.A. ( Site 0400)
  • Instituto De Cancerologia S.A. ( Site 0406)
  • CHU Jean Minjoz ( Site 0917)
  • Polyclinique Bordeaux Nord Aquitaine ( Site 0911)
  • Centre Francois Baclesse ( Site 0907)
  • Centre Jean Perrin ( Site 0903)
  • Clinique Victor Hugo ( Site 0901)
  • Hopital prive du Confluent ( Site 0902)
  • Institut Curie ( Site 0909)
  • Hopital Saint Louis ( Site 0908)
  • Hopital Diaconesses Croix Saint Simon ( Site 0905)
  • CHU de la Miletrie Poitiers ( Site 0913)
  • Institut Claudius Regaud IUCT Oncopole ( Site 0914)
  • HELIOS Klinikum Berlin-Buch ( Site 1005)
  • Gynaekologisches Zentrum ( Site 1004)
  • Universitaetsklinikum Erlangen ( Site 1001)
  • Kliniken Essen Mitte ( Site 1012)
  • Universitaetsklinik und Poliklinik Halle/Saale ( Site 1008)
  • Universitaetsklinikum Hamburg-Eppendorf ( Site 1007)
  • Klinikum der Universit. Muenchen ( Site 1002)
  • Caritasklinik St. Theresia ( Site 1011)
  • Universitaets-Frauenklinik Tuebingen ( Site 1003)
  • Bon Secours Hospital ( Site 1551)
  • St Vincents University Hospital ( Site 1550)
  • Oncology institute ( Site 1601)
  • Assaf Harofeh MC ( Site 1605)
  • Hadassah Ein Karem - Sharett Institute of Oncology ( Site 1600)
  • Rabin-Medical Center ( Site 1604)
  • Sheba Medical Center ( Site 1602)
  • Sourasky Medical Center ( Site 1603)
  • Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 1101)
  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia ( Site 1103)
  • Ospedale San Luca, AZIENDA USL2 TOSCANA NORD OVEST ( Site 1105)
  • Ospedale Civile di Macerata ( Site 1104)
  • Istituto Europeo di Oncologia ( Site 1106)
  • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1102)
  • Aichi Cancer Center Hospital ( Site 2502)
  • National Cancer Center Hospital East ( Site 2518)
  • National Hospital Organization Hokkaido Cancer Center ( Site 2512)
  • Hyogo College of Medicine Hospital ( Site 2506)
  • Tokai University Hospital ( Site 2517)
  • St. Marianna University School of Medicine Hospital ( Site 2516)
  • Kindai University Hospital ( Site 2507)
  • Saitama Medical University International Medical Center ( Site 2513)
  • Saitama Cancer Center ( Site 2510)
  • Shizuoka Cancer Center Hospital and Research Institute ( Site 2514)
  • Chiba Cancer Center ( Site 2519)
  • Hiroshima City Hiroshima Citizens Hospital ( Site 2501)
  • Social medical corporation Hakuaikai Sagara Hospital ( Site 2508)
  • Kumamoto University Hospital ( Site 2515)
  • National Hospital Organization Osaka National Hospital ( Site 2505)
  • National Cancer Center Hospital ( Site 2500)
  • St.Luke's International Hospital ( Site 2511)
  • Toranomon Hospital ( Site 2503)
  • The Cancer Institute Hospital of JFCR ( Site 2509)
  • Seoul National University Hospital ( Site 2101)
  • Severance Hospital Yonsei University Health System ( Site 2100)
  • Asan Medical Center ( Site 2102)
  • Samsung Medical Center ( Site 2103)
  • Mazowiecki Szpital Onkologiczny ( Site 1713)
  • Centrum Onkologii Instytut im. Marii Skłodowskiej Curie ( Site 1717)
  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1708)
  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1712)
  • Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1701)
  • Centrum Onkologii Instytut im. Marii Sklodowskiej Curie ( Site 1719)
  • Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli ( Site 1700)
  • Dolnoslaskie Centrum Onkologii. ( Site 1702)
  • Fundacao Champalimaud ( Site 2444)
  • Hospital de Santa Maria, E.P.E. ( Site 2445)
  • Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 2446)
  • Arkhangelsk Clinical Oncological Dispensary ( Site 1810)
  • Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1805)
  • Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1806)
  • Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 1801)
  • GBU RO Regional Clinical Oncological Dispensary ( Site 1808)
  • Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1803)
  • Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1804)
  • National Cancer Centre Singapore ( Site 2600)
  • ICO L Hospitalet ( Site 1305)
  • Hospital Quiron de Madrid ( Site 1303)
  • Hospital del Mar ( Site 1306)
  • Instituto Oncologico Baselga.Hospital Quiron. ( Site 1312)
  • Hospital General Universitari Vall d Hebron ( Site 1301)
  • Hospital Universitario Reina Sofia ( Site 1304)
  • Hospital Universitario Ramon y Cajal ( Site 1300)
  • Complejo Hospitalario Universitario de Santiago ( Site 1308)
  • Hospital Universitario Virgen del Rocio ( Site 1314)
  • Hospital Clinico Univ de Valencia ( Site 1313)
  • Linkopings Universitetssjukhus ( Site 1402)
  • Karolinska Universitetssjukhuset Solna ( Site 1404)
  • Norrlands Universitetssjukhus ( Site 1401)
  • Akademiska Sjukhuset ( Site 1403)
  • Taipei Veterans General Hospital ( Site 2302)
  • National Cheng Kung University Hospital ( Site 2305)
  • National Taiwan University Hospital ( Site 2301)
  • MacKay Memorial Hospital ( Site 2303)
  • Koo Foundation Sun Yat-Sen Cancer Center ( Site 2304)
  • Linkou Chang Gung Memorial Hospital ( Site 2300)
  • Samsun Ondokuz Mayıs Universitesi Tıp Fakultesi Hastanesi ( Site 1910)
  • Adana Acıbadem Hospital Department of Medical Oncology ( Site 1906)
  • Baskent Unıversity Adana Kısla Hospital ( Site 1903)
  • Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1912)
  • Abdurrahman Yurtaslan Oncology Training and Research Hospital ( Site 1909)
  • Ozel Medicana International Ankara Hastanesi ( Site 1915)
  • Antalya Memorial Hospital Department of Medical Oncology ( Site 1908)
  • Trakya University Medical Faculty Balkan Oncology Hospital ( Site 1901)
  • Acibadem Altunizade Hastanesi ( Site 1900)
  • İstanbul University Cerrahpaşa Medical Faculty ( Site 1904)
  • Amerikan Hospital Medical ( Site 1902)
  • Memorial Sisli Hastanesi ( Site 1913)
  • Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 1905)
  • Izmir Medical Park Hospital Department of Medical Oncology ( Site 1907)
  • Colchester General Hospital ( Site 1508)
  • Barts Cancer Institute ( Site 1500)
  • St George s Hospital ( Site 1516)
  • Maidstone Hospital ( Site 1511)
  • The James Cook University Hospital ( Site 1515)
  • Nottingham University Hospitals NHS Trust ( Site 1505)
  • Royal Cornwall Hospitals NHS Trust ( Site 1504)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pembrolizumab + Chemotherapy

Placebo + Chemotherapy

Arm Description

Participants receive pembrolizumab every 3 weeks (Q3W) + paclitaxel weekly + carboplatin (weekly or Q3W) x 4 cycles, followed by pembrolizumab Q3W + (doxorubicin OR epirubicin) + cyclophosphamide Q3W x 4 cycles as neoadjuvant therapy prior to surgery; followed by 9 cycles of pembrolizumab Q3W as adjuvant therapy post-surgery. Each cycle is 21 days.

Participants receive placebo (normal saline solution) Q3W + paclitaxel weekly + carboplatin (weekly or Q3W) x 4 cycles, followed by placebo + (doxorubicin OR epirubicin) + cyclophosphamide Q3W x 4 cycles as neoadjuvant therapy prior to surgery; followed by 9 cycles of placebo Q3W as adjuvant therapy post-surgery. Each cycle is 21 days.

Outcomes

Primary Outcome Measures

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
pCR rate (ypT0/Tis ypN0) is defined as the percentage of participants without residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by current American Joint Committee on Cancer (AJCC) staging criteria assessed by the local pathologist at the time of definitive surgery.
Event-free Survival (EFS) as assessed by Investigator
EFS is defined as the time from randomization to any of the following events: progression of disease that precludes surgery, local or distant recurrence, second primary malignancy (breast or other cancers) or death due to any cause.

Secondary Outcome Measures

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
pCR rate (ypT0 ypN0) is defined as the percentage of participants without residual invasive and in situ cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by current AJCC staging criteria assessed by the local pathologist at the time of definitive surgery in all participants and in participants with tumors expressing Programmed Death-Ligand 1 (PD-L1).
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
pCR rate (ypT0/Tis) is defined as the percentage of participants without invasive cancer in the breast irrespective of ductal carcinoma in situ or nodal involvement following completion of neoadjuvant systemic therapy by current AJCC staging criteria assessed by the local pathologist at the time of definitive surgery in participants with tumors expressing PD-L1.
EFS in participants with tumors expressing PD-L1
EFS is defined as the time from randomization to any of the following events: progression of disease that precludes surgery, local or distant recurrence, second primary malignancy (breast or other cancers) or death due to any cause.
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
pCR rate (ypT0/Tis) is defined as the percentage of participants without invasive cancer in the breast irrespective of ductal carcinoma in situ or nodal involvement following completion of neoadjuvant systemic therapy by current AJCC staging criteria assessed by the local pathologist at the time of definitive surgery in all participants and in participants with tumors expressing PD-L1.
Overall survival (OS)
OS is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis will be censored at the date of the last follow-up.
Percentage of participants who experience an adverse event (AE)
An AE is defined as any untoward medical occurrence in a participant administered study treatment which does not necessarily have to have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment or protocol-specified procedure, whether or not considered related to study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE.
Percentage of participants who discontinue study treatment due to an AE
An AE is defined as any untoward medical occurrence in a participant administered study treatment which does not necessarily have to have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment or protocol-specified procedure, whether or not considered related to study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE.
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Core 30 Questionnaire (QLQ-C30) score
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Individual responses are given on a 4-point scale (1=Not at All to 4=Very Much), with a lower score indicating a better outcome. The EORTC-QLQ-C30 score will be presented for all participants and for participants with tumors expressing PD-L1.
EORTC Breast Cancer-Specific QoL Questionnaire (QLQ-BR23) score
The EORTC-QLQ-BR23 is a 23-item questionnaire developed to assess the quality of life of breast cancer patients. Individual responses are given on a 4-point scale (1=Not at All to 4=Very Much), with a lower score indicating a better outcome. The EORTC-QLQ-BR23 score will be presented for all participants and for participants with tumors expressing PD-L1.

Full Information

First Posted
January 27, 2017
Last Updated
June 28, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03036488
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 7, 2017 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple Negative Breast Neoplasms
Keywords
PD1, PD-1, PDL1, PD-L1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1174 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pembrolizumab + Chemotherapy
Arm Type
Experimental
Arm Description
Participants receive pembrolizumab every 3 weeks (Q3W) + paclitaxel weekly + carboplatin (weekly or Q3W) x 4 cycles, followed by pembrolizumab Q3W + (doxorubicin OR epirubicin) + cyclophosphamide Q3W x 4 cycles as neoadjuvant therapy prior to surgery; followed by 9 cycles of pembrolizumab Q3W as adjuvant therapy post-surgery. Each cycle is 21 days.
Arm Title
Placebo + Chemotherapy
Arm Type
Active Comparator
Arm Description
Participants receive placebo (normal saline solution) Q3W + paclitaxel weekly + carboplatin (weekly or Q3W) x 4 cycles, followed by placebo + (doxorubicin OR epirubicin) + cyclophosphamide Q3W x 4 cycles as neoadjuvant therapy prior to surgery; followed by 9 cycles of placebo Q3W as adjuvant therapy post-surgery. Each cycle is 21 days.
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
MK-3475, KEYTRUDA®
Intervention Description
On Day 1 of each cycle in the neoadjuvant and adjuvant phases of the study for a total of 17 cycles; intravenous (IV) infusion.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
PARAPLATIN®
Intervention Description
On Day 1 of Cycles 1-4 of the neoadjuvant phase of the study OR on Days 1, 8, 15 of Cycles 1-4 of the neoadjuvant phase of the study; IV infusion.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
TAXOL®
Intervention Description
On Days 1, 8 and 15 of Cycles 1-4 in the neoadjuvant phase of the study; IV infusion.
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Other Intervention Name(s)
ADRIAMYCIN®
Intervention Description
On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV injection.
Intervention Type
Drug
Intervention Name(s)
Epirubicin
Other Intervention Name(s)
ELLENCE®
Intervention Description
On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV injection.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
CYTOXAN®
Intervention Description
On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV infusion.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
normal saline solution or dextrose: On Day 1 of each cycle in the neoadjuvant and adjuvant phases of the study for a total of 17 cycles; IV infusion
Intervention Type
Biological
Intervention Name(s)
Granulocyte colony stimulating factor: Filgrastim or Pegfilgastrim
Other Intervention Name(s)
NEUPOGEN®, NEULASTA®
Intervention Description
For prevention of neutropenia, filgrastim 5 μg/kg/day via subcutaneous (SC) injection administered per standard of care after chemotherapy OR pegfilgastrim 100 µg/kg (individualized) or 6 mg (general approach) via SC injection administered per standard of care.
Primary Outcome Measure Information:
Title
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
Description
pCR rate (ypT0/Tis ypN0) is defined as the percentage of participants without residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by current American Joint Committee on Cancer (AJCC) staging criteria assessed by the local pathologist at the time of definitive surgery.
Time Frame
Up to approximately 27-30 weeks
Title
Event-free Survival (EFS) as assessed by Investigator
Description
EFS is defined as the time from randomization to any of the following events: progression of disease that precludes surgery, local or distant recurrence, second primary malignancy (breast or other cancers) or death due to any cause.
Time Frame
Up to approximately 8 years
Secondary Outcome Measure Information:
Title
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
Description
pCR rate (ypT0 ypN0) is defined as the percentage of participants without residual invasive and in situ cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by current AJCC staging criteria assessed by the local pathologist at the time of definitive surgery in all participants and in participants with tumors expressing Programmed Death-Ligand 1 (PD-L1).
Time Frame
Up to approximately 27-30 weeks
Title
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
Description
pCR rate (ypT0/Tis) is defined as the percentage of participants without invasive cancer in the breast irrespective of ductal carcinoma in situ or nodal involvement following completion of neoadjuvant systemic therapy by current AJCC staging criteria assessed by the local pathologist at the time of definitive surgery in participants with tumors expressing PD-L1.
Time Frame
Up to approximately 27-30 weeks
Title
EFS in participants with tumors expressing PD-L1
Description
EFS is defined as the time from randomization to any of the following events: progression of disease that precludes surgery, local or distant recurrence, second primary malignancy (breast or other cancers) or death due to any cause.
Time Frame
Up to approximately 8 years
Title
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
Description
pCR rate (ypT0/Tis) is defined as the percentage of participants without invasive cancer in the breast irrespective of ductal carcinoma in situ or nodal involvement following completion of neoadjuvant systemic therapy by current AJCC staging criteria assessed by the local pathologist at the time of definitive surgery in all participants and in participants with tumors expressing PD-L1.
Time Frame
Up to approximately 27-30 weeks
Title
Overall survival (OS)
Description
OS is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis will be censored at the date of the last follow-up.
Time Frame
Up to approximately 8 years
Title
Percentage of participants who experience an adverse event (AE)
Description
An AE is defined as any untoward medical occurrence in a participant administered study treatment which does not necessarily have to have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment or protocol-specified procedure, whether or not considered related to study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE.
Time Frame
Up to approximately 61 weeks
Title
Percentage of participants who discontinue study treatment due to an AE
Description
An AE is defined as any untoward medical occurrence in a participant administered study treatment which does not necessarily have to have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment or protocol-specified procedure, whether or not considered related to study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE.
Time Frame
Up to approximately 57 weeks
Title
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Core 30 Questionnaire (QLQ-C30) score
Description
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Individual responses are given on a 4-point scale (1=Not at All to 4=Very Much), with a lower score indicating a better outcome. The EORTC-QLQ-C30 score will be presented for all participants and for participants with tumors expressing PD-L1.
Time Frame
Up to approximately 27-30 weeks
Title
EORTC Breast Cancer-Specific QoL Questionnaire (QLQ-BR23) score
Description
The EORTC-QLQ-BR23 is a 23-item questionnaire developed to assess the quality of life of breast cancer patients. Individual responses are given on a 4-point scale (1=Not at All to 4=Very Much), with a lower score indicating a better outcome. The EORTC-QLQ-BR23 score will be presented for all participants and for participants with tumors expressing PD-L1.
Time Frame
Up to approximately 27-30 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Virginia G. Piper Cancer Center Pharmacy - Scottsdale Healthcare ( Site 0089)
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85268
Country
United States
Facility Name
Arizona Oncology Associates PC- HOPE ( Site 8001)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
Cedars Sinai Medical Center ( Site 0091)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Pacific Cancer Care ( Site 0069)
City
Monterey
State/Province
California
ZIP/Postal Code
93940
Country
United States
Facility Name
ICRI ( Site 0072)
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
University of Colorado Cancer Center ( Site 0021)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale University School of Medicine ( Site 0054)
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Christiana Hospital ( Site 0029)
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Univ of Miami-Sylvester Comprehensive Cancer Center- Kendall satellite ( Site 0079)
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
The University of Chicago Medical Center ( Site 0047)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1447
Country
United States
Facility Name
North Shore University Health System ( Site 0081)
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Orchard Healthcare Research Inc. ( Site 0049)
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Goshen Center for Cancer Care ( Site 0010)
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Facility Name
University of Iowa Hospital and Clinics ( Site 0038)
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
New England Cancer Specialists ( Site 0005)
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Henry Ford Hospital ( Site 0003)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Minnesota Oncology Hematology, PA ( Site 8013)
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey ( Site 0073)
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Broome Oncology, LLC ( Site 8002)
City
Johnson City
State/Province
New York
ZIP/Postal Code
13790
Country
United States
Facility Name
Nyack Hospital Infusion Center ( Site 0059)
City
Nyack
State/Province
New York
ZIP/Postal Code
10960
Country
United States
Facility Name
TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0044)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Oncology Hematology Care, Inc. ( Site 8011)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Providence Portland Medical Center ( Site 0052)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Northwest Cancer Specialists, P.C. ( Site 8008)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Magee - Women's Hospital ( Site 0011)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Rhode Island Hospital ( Site 0060)
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
The West Clinic, P.C. ( Site 0078)
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Texas Oncology-Austin Central ( Site 8005)
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Parkland Health and Hospital System ( Site 0093)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 8006)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Simmons Cancer Center ( Site 0094)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9015
Country
United States
Facility Name
UT Southwestern Medical Center ( Site 0030)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9179
Country
United States
Facility Name
Moncrief Cancer Institute ( Site 0092)
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Texas Oncology-Memorial City ( Site 8003)
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Houston Methodist Cancer Center ( Site 0013)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Oncology- Plano East ( Site 8010)
City
Plano
State/Province
Texas
ZIP/Postal Code
75075
Country
United States
Facility Name
Texas Oncology-San Antonio Northeast ( Site 8012)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Texas Oncology-Tyler ( Site 8007)
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
University of Virginia ( Site 0022)
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Virginia Cancer Specialists, PC ( Site 8009)
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Bon Secours Cancer Institute Medical Oncology at St. Mary's ( Site 0033)
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23114
Country
United States
Facility Name
Peninsula Cancer Institute, LLC ( Site 0041)
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23601
Country
United States
Facility Name
Virginia Oncology Associates ( Site 8000)
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Kadlec Clinic Hematology and Oncology ( Site 0087)
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
Seattle Cancer Care Alliance ( Site 0068)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Medical Oncology Associates (Summit Cancer Centers) ( Site 0014)
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Facility Name
YVMH dba Vrigina Mason Memorial/North Star Lodge Cancer Center ( Site 8004)
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Facility Name
Royal North Shore Hospital ( Site 2000)
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Westmead Hospital ( Site 2002)
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Royal Adelaide Hospital ( Site 2008)
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Cabrini Health ( Site 2009)
City
East Malvern
State/Province
Victoria
ZIP/Postal Code
3145
Country
Australia
Facility Name
Frankston Hospital ( Site 2010)
City
Franskton
ZIP/Postal Code
3199
Country
Australia
Facility Name
Royal Brisbane and Women s Hospital ( Site 2003)
City
Herston
ZIP/Postal Code
4029
Country
Australia
Facility Name
St John of God Subiaco Hospital ( Site 2006)
City
Perth
ZIP/Postal Code
6008
Country
Australia
Facility Name
Hospital Nossa Senhora da Conceicao ( Site 0203)
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
UOPECCAN - Uniao Oeste Paranaense de Estudos e Combate ao Cancer ( Site 0206)
City
Cascavel
ZIP/Postal Code
85806-300
Country
Brazil
Facility Name
Universidade de Caxias do Sul ( Site 0201)
City
Caxias do Sul
ZIP/Postal Code
95070-560
Country
Brazil
Facility Name
Hospital Erasto Gaertner ( Site 0207)
City
Curitiba
ZIP/Postal Code
81520-060
Country
Brazil
Facility Name
Instituto do Cancer do Ceara ( Site 0205)
City
Fortaleza
ZIP/Postal Code
60430-230
Country
Brazil
Facility Name
Hospital Araujo Jorge ( Site 0204)
City
Goiania
ZIP/Postal Code
74605-070
Country
Brazil
Facility Name
Hospital Sao Lucas da PUCRS ( Site 0200)
City
Porto Alegre
ZIP/Postal Code
90610-900
Country
Brazil
Facility Name
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto ( Site 0208)
City
Sao Jose do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Instituto do Cancer de Sao Paulo - ICESP ( Site 0211)
City
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Tom Baker Cancer Centre ( Site 0105)
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
The Ottawa Hospital - Cancer Care ( Site 0100)
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Princess Margaret Cancer Centre ( Site 0103)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0106)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0C1
Country
Canada
Facility Name
Jewish General Hospital ( Site 0101)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
CIUSSS de l'Estrie-CHUS ( Site 0102)
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
CHU de Quebec Universite Laval - Hopital du Saint-Sacrement ( Site 0104)
City
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
Facility Name
Oncomedica S.A. ( Site 0404)
City
Monteria
State/Province
Cordoba
ZIP/Postal Code
230002
Country
Colombia
Facility Name
Oncologos del Occidente S.A. ( Site 0405)
City
Pereira
State/Province
Risaralda
ZIP/Postal Code
661002
Country
Colombia
Facility Name
Hospital Universitario San Ignacio ( Site 0401)
City
Bogota
ZIP/Postal Code
110231
Country
Colombia
Facility Name
Instituto Nacional de Cancerologia [Bogota-Colombia] ( Site 0403)
City
Bogota
ZIP/Postal Code
110411
Country
Colombia
Facility Name
Hemato Oncologos S.A. ( Site 0400)
City
Cali
ZIP/Postal Code
760001
Country
Colombia
Facility Name
Instituto De Cancerologia S.A. ( Site 0406)
City
Medellin
ZIP/Postal Code
050024
Country
Colombia
Facility Name
CHU Jean Minjoz ( Site 0917)
City
Besancon
ZIP/Postal Code
25000
Country
France
Facility Name
Polyclinique Bordeaux Nord Aquitaine ( Site 0911)
City
Bordeaux
ZIP/Postal Code
33077
Country
France
Facility Name
Centre Francois Baclesse ( Site 0907)
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Centre Jean Perrin ( Site 0903)
City
Clermont-Ferrand Cedex 01
ZIP/Postal Code
63001
Country
France
Facility Name
Clinique Victor Hugo ( Site 0901)
City
Le Mans
ZIP/Postal Code
72015
Country
France
Facility Name
Hopital prive du Confluent ( Site 0902)
City
Nantes
ZIP/Postal Code
44277
Country
France
Facility Name
Institut Curie ( Site 0909)
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Hopital Saint Louis ( Site 0908)
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hopital Diaconesses Croix Saint Simon ( Site 0905)
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
CHU de la Miletrie Poitiers ( Site 0913)
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Institut Claudius Regaud IUCT Oncopole ( Site 0914)
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
HELIOS Klinikum Berlin-Buch ( Site 1005)
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Gynaekologisches Zentrum ( Site 1004)
City
Bonn
ZIP/Postal Code
53111
Country
Germany
Facility Name
Universitaetsklinikum Erlangen ( Site 1001)
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Kliniken Essen Mitte ( Site 1012)
City
Essen
ZIP/Postal Code
45136
Country
Germany
Facility Name
Universitaetsklinik und Poliklinik Halle/Saale ( Site 1008)
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Universitaetsklinikum Hamburg-Eppendorf ( Site 1007)
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Klinikum der Universit. Muenchen ( Site 1002)
City
Muenchen
ZIP/Postal Code
80337
Country
Germany
Facility Name
Caritasklinik St. Theresia ( Site 1011)
City
Saarbruecken
ZIP/Postal Code
66113
Country
Germany
Facility Name
Universitaets-Frauenklinik Tuebingen ( Site 1003)
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Bon Secours Hospital ( Site 1551)
City
Cork
ZIP/Postal Code
T12 DV56
Country
Ireland
Facility Name
St Vincents University Hospital ( Site 1550)
City
Dublin
ZIP/Postal Code
D04 T6F4
Country
Ireland
Facility Name
Oncology institute ( Site 1601)
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
Facility Name
Assaf Harofeh MC ( Site 1605)
City
Beer Yaakov-Zerifin
ZIP/Postal Code
7030001
Country
Israel
Facility Name
Hadassah Ein Karem - Sharett Institute of Oncology ( Site 1600)
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Rabin-Medical Center ( Site 1604)
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Sheba Medical Center ( Site 1602)
City
Ramat-Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Sourasky Medical Center ( Site 1603)
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 1101)
City
Meldola
State/Province
FC
ZIP/Postal Code
47014
Country
Italy
Facility Name
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia ( Site 1103)
City
Brescia
ZIP/Postal Code
25100
Country
Italy
Facility Name
Ospedale San Luca, AZIENDA USL2 TOSCANA NORD OVEST ( Site 1105)
City
Lucca
ZIP/Postal Code
55100
Country
Italy
Facility Name
Ospedale Civile di Macerata ( Site 1104)
City
Macerata
ZIP/Postal Code
62100
Country
Italy
Facility Name
Istituto Europeo di Oncologia ( Site 1106)
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1102)
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Aichi Cancer Center Hospital ( Site 2502)
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Facility Name
National Cancer Center Hospital East ( Site 2518)
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
National Hospital Organization Hokkaido Cancer Center ( Site 2512)
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
Facility Name
Hyogo College of Medicine Hospital ( Site 2506)
City
Nishinomiya
State/Province
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Tokai University Hospital ( Site 2517)
City
Isehara
State/Province
Kanagawa
ZIP/Postal Code
259-1193
Country
Japan
Facility Name
St. Marianna University School of Medicine Hospital ( Site 2516)
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
Kindai University Hospital ( Site 2507)
City
Osakasayama
State/Province
Osaka
ZIP/Postal Code
589-8511
Country
Japan
Facility Name
Saitama Medical University International Medical Center ( Site 2513)
City
Hidaka
State/Province
Saitama
ZIP/Postal Code
350-1298
Country
Japan
Facility Name
Saitama Cancer Center ( Site 2510)
City
Kitaadachi-gun
State/Province
Saitama
ZIP/Postal Code
362-0806
Country
Japan
Facility Name
Shizuoka Cancer Center Hospital and Research Institute ( Site 2514)
City
Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Facility Name
Chiba Cancer Center ( Site 2519)
City
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Facility Name
Hiroshima City Hiroshima Citizens Hospital ( Site 2501)
City
Hiroshima
ZIP/Postal Code
730-8518
Country
Japan
Facility Name
Social medical corporation Hakuaikai Sagara Hospital ( Site 2508)
City
Kagoshima
ZIP/Postal Code
892-0833
Country
Japan
Facility Name
Kumamoto University Hospital ( Site 2515)
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
National Hospital Organization Osaka National Hospital ( Site 2505)
City
Osaka
ZIP/Postal Code
540-0006
Country
Japan
Facility Name
National Cancer Center Hospital ( Site 2500)
City
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Facility Name
St.Luke's International Hospital ( Site 2511)
City
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
Toranomon Hospital ( Site 2503)
City
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
The Cancer Institute Hospital of JFCR ( Site 2509)
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Seoul National University Hospital ( Site 2101)
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital Yonsei University Health System ( Site 2100)
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center ( Site 2102)
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center ( Site 2103)
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Mazowiecki Szpital Onkologiczny ( Site 1713)
City
Wieliszew
State/Province
Mazowieckie
ZIP/Postal Code
05-135
Country
Poland
Facility Name
Centrum Onkologii Instytut im. Marii Skłodowskiej Curie ( Site 1717)
City
Gliwice
State/Province
Slaskie
ZIP/Postal Code
44-101
Country
Poland
Facility Name
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1708)
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1712)
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 1701)
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Facility Name
Centrum Onkologii Instytut im. Marii Sklodowskiej Curie ( Site 1719)
City
Krakow
ZIP/Postal Code
31-115
Country
Poland
Facility Name
Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli ( Site 1700)
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Dolnoslaskie Centrum Onkologii. ( Site 1702)
City
Wroclaw
ZIP/Postal Code
53-413
Country
Poland
Facility Name
Fundacao Champalimaud ( Site 2444)
City
Lisboa
ZIP/Postal Code
1400-038
Country
Portugal
Facility Name
Hospital de Santa Maria, E.P.E. ( Site 2445)
City
Lisboa
ZIP/Postal Code
1600-190
Country
Portugal
Facility Name
Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 2446)
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
Arkhangelsk Clinical Oncological Dispensary ( Site 1810)
City
Arkhangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1805)
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1806)
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 1801)
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
GBU RO Regional Clinical Oncological Dispensary ( Site 1808)
City
Ryazan
ZIP/Postal Code
390046
Country
Russian Federation
Facility Name
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1803)
City
Saint Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1804)
City
Ufa
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
National Cancer Centre Singapore ( Site 2600)
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
ICO L Hospitalet ( Site 1305)
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital Quiron de Madrid ( Site 1303)
City
Pozuelo de Alarcon
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Hospital del Mar ( Site 1306)
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Instituto Oncologico Baselga.Hospital Quiron. ( Site 1312)
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
Facility Name
Hospital General Universitari Vall d Hebron ( Site 1301)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Reina Sofia ( Site 1304)
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal ( Site 1300)
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Santiago ( Site 1308)
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio ( Site 1314)
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Clinico Univ de Valencia ( Site 1313)
City
Valencia
ZIP/Postal Code
46011
Country
Spain
Facility Name
Linkopings Universitetssjukhus ( Site 1402)
City
Linkoping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset Solna ( Site 1404)
City
Solna
ZIP/Postal Code
171 64
Country
Sweden
Facility Name
Norrlands Universitetssjukhus ( Site 1401)
City
Umea
ZIP/Postal Code
901 85
Country
Sweden
Facility Name
Akademiska Sjukhuset ( Site 1403)
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Taipei Veterans General Hospital ( Site 2302)
City
Taipei
State/Province
Beitou
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
National Cheng Kung University Hospital ( Site 2305)
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital ( Site 2301)
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
MacKay Memorial Hospital ( Site 2303)
City
Taipei
ZIP/Postal Code
105
Country
Taiwan
Facility Name
Koo Foundation Sun Yat-Sen Cancer Center ( Site 2304)
City
Taipei
ZIP/Postal Code
11259
Country
Taiwan
Facility Name
Linkou Chang Gung Memorial Hospital ( Site 2300)
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Samsun Ondokuz Mayıs Universitesi Tıp Fakultesi Hastanesi ( Site 1910)
City
Samsun
State/Province
Atakum
ZIP/Postal Code
55280
Country
Turkey
Facility Name
Adana Acıbadem Hospital Department of Medical Oncology ( Site 1906)
City
Adana
ZIP/Postal Code
01130
Country
Turkey
Facility Name
Baskent Unıversity Adana Kısla Hospital ( Site 1903)
City
Adana
ZIP/Postal Code
01250
Country
Turkey
Facility Name
Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1912)
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Abdurrahman Yurtaslan Oncology Training and Research Hospital ( Site 1909)
City
Ankara
ZIP/Postal Code
06200
Country
Turkey
Facility Name
Ozel Medicana International Ankara Hastanesi ( Site 1915)
City
Ankara
ZIP/Postal Code
06510
Country
Turkey
Facility Name
Antalya Memorial Hospital Department of Medical Oncology ( Site 1908)
City
Antalya
ZIP/Postal Code
07020
Country
Turkey
Facility Name
Trakya University Medical Faculty Balkan Oncology Hospital ( Site 1901)
City
Edirne
ZIP/Postal Code
22030
Country
Turkey
Facility Name
Acibadem Altunizade Hastanesi ( Site 1900)
City
Istambul
ZIP/Postal Code
34662
Country
Turkey
Facility Name
İstanbul University Cerrahpaşa Medical Faculty ( Site 1904)
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Amerikan Hospital Medical ( Site 1902)
City
Istanbul
ZIP/Postal Code
34365
Country
Turkey
Facility Name
Memorial Sisli Hastanesi ( Site 1913)
City
Istanbul
ZIP/Postal Code
34384
Country
Turkey
Facility Name
Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 1905)
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
Facility Name
Izmir Medical Park Hospital Department of Medical Oncology ( Site 1907)
City
Izmir
ZIP/Postal Code
35575
Country
Turkey
Facility Name
Colchester General Hospital ( Site 1508)
City
Colchester
State/Province
Essex
ZIP/Postal Code
CO4 5JL
Country
United Kingdom
Facility Name
Barts Cancer Institute ( Site 1500)
City
London
ZIP/Postal Code
EC1M 6BQ
Country
United Kingdom
Facility Name
St George s Hospital ( Site 1516)
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Maidstone Hospital ( Site 1511)
City
Maidstone
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
The James Cook University Hospital ( Site 1515)
City
Middlesbrough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust ( Site 1505)
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Royal Cornwall Hospitals NHS Trust ( Site 1504)
City
Truro
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
35139274
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.
Results Reference
derived
PubMed Identifier
32450725
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.
Results Reference
derived
PubMed Identifier
32101663
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.
Results Reference
derived
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trial Information
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=3475-522&&kw=3475-522
Description
Plain Language Summary

Learn more about this 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)

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