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.
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).
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There are 190 Locations for this study
Scottsdale Arizona, 85268, United States
Tucson Arizona, 85711, United States
Los Angeles California, 90048, United States
Monterey California, 93940, United States
Whittier California, 90603, United States
Aurora Colorado, 80045, United States
New Haven Connecticut, 06510, United States
Newark Delaware, 19713, United States
Miami Florida, 33176, United States
Chicago Illinois, 60637, United States
Evanston Illinois, 60201, United States
Skokie Illinois, 60077, United States
Goshen Indiana, 46526, United States
Iowa City Iowa, 52242, United States
Scarborough Maine, 04074, United States
Detroit Michigan, 48202, United States
Minneapolis Minnesota, 55404, United States
New Brunswick New Jersey, 08903, United States
Johnson City New York, 13790, United States
Nyack New York, 10960, United States
Cincinnati Ohio, 45220, United States
Cincinnati Ohio, 45242, United States
Portland Oregon, 97213, United States
Portland Oregon, 97227, United States
Pittsburgh Pennsylvania, 15213, United States
Providence Rhode Island, 02903, United States
Germantown Tennessee, 38138, United States
Austin Texas, 78731, United States
Dallas Texas, 75235, United States
Dallas Texas, 75246, United States
Dallas Texas, 75390, United States
Dallas Texas, 75390, United States
Fort Worth Texas, 76104, United States
Houston Texas, 77024, United States
Houston Texas, 77030, United States
Plano Texas, 75075, United States
San Antonio Texas, 78217, United States
Tyler Texas, 75702, United States
Charlottesville Virginia, 22903, United States
Fairfax Virginia, 22031, United States
Midlothian Virginia, 23114, United States
Newport News Virginia, 23601, United States
Norfolk Virginia, 23502, United States
Kennewick Washington, 99336, United States
Seattle Washington, 98109, United States
Spokane Washington, 99208, United States
Yakima Washington, 98902, United States
Sydney New South Wales, 2065, Australia
Sydney New South Wales, 2145, Australia
Adelaide South Australia, 5000, Australia
East Malvern Victoria, 3145, Australia
Franskton , 3199, Australia
Herston , 4029, Australia
Perth , 6008, Australia
Porto Alegre Rio Grande Do Sul, 91350, Brazil
Cascavel , 85806, Brazil
Caxias do Sul , 95070, Brazil
Curitiba , 81520, Brazil
Fortaleza , 60430, Brazil
Goiania , 74605, Brazil
Porto Alegre , 90610, Brazil
Sao Jose do Rio Preto , 15090, Brazil
Sao Paulo , 01246, Brazil
Calgary Alberta, T2N 4, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M5G 2, Canada
Montreal Quebec, H2X 0, Canada
Montreal Quebec, H3T 1, Canada
Sherbrooke Quebec, J1H 5, Canada
Quebec , G1S 4, Canada
Monteria Cordoba, 23000, Colombia
Pereira Risaralda, 66100, Colombia
Bogota , 11023, Colombia
Bogota , 11041, Colombia
Cali , 76000, Colombia
Medellin , 05002, Colombia
Besancon , 25000, France
Bordeaux , 33077, France
Caen , 14000, France
Clermont-Ferrand Cedex 01 , 63001, France
Le Mans , 72015, France
Nantes , 44277, France
Paris , 75005, France
Paris , 75010, France
Paris , 75020, France
Poitiers , 86021, France
Toulouse Cedex 9 , 31059, France
Berlin , 13125, Germany
Bonn , 53111, Germany
Erlangen , 91054, Germany
Essen , 45136, Germany
Halle , 06120, Germany
Hamburg , 20246, Germany
Muenchen , 80337, Germany
Saarbruecken , 66113, Germany
Tubingen , 72076, Germany
Cork , T12 D, Ireland
Dublin , D04 T, Ireland
Beer Sheva , 84101, Israel
Beer Yaakov-Zerifin , 70300, Israel
Jerusalem , 91120, Israel
Petah Tikva , 49414, Israel
Ramat-Gan , 52656, Israel
Tel Aviv , 64239, Israel
Meldola FC, 47014, Italy
Brescia , 25100, Italy
Lucca , 55100, Italy
Macerata , 62100, Italy
Milano , 20141, Italy
Napoli , 80131, Italy
Nagoya Aichi, 464-8, Japan
Kashiwa Chiba, 277-8, Japan
Sapporo Hokkaido, 003-0, Japan
Nishinomiya Hyogo, 663-8, Japan
Isehara Kanagawa, 259-1, Japan
Kawasaki Kanagawa, 216-8, Japan
Osakasayama Osaka, 589-8, Japan
Hidaka Saitama, 350-1, Japan
Kitaadachi-gun Saitama, 362-0, Japan
Sunto-gun Shizuoka, 411-8, Japan
Chiba , 260-8, Japan
Hiroshima , 730-8, Japan
Kagoshima , 892-0, Japan
Kumamoto , 860-8, Japan
Osaka , 540-0, Japan
Tokyo , 104-0, Japan
Tokyo , 104-8, Japan
Tokyo , 105-8, Japan
Tokyo , 135-8, Japan
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Wieliszew Mazowieckie, 05-13, Poland
Gliwice Slaskie, 44-10, Poland
Bydgoszcz , 85-79, Poland
Bydgoszcz , 85-79, Poland
Gdynia , 81-51, Poland
Krakow , 31-11, Poland
Lublin , 20-09, Poland
Wroclaw , 53-41, Poland
Lisboa , 1400-, Portugal
Lisboa , 1600-, Portugal
Porto , 4200-, Portugal
Arkhangelsk , 16304, Russian Federation
Chelyabinsk , 45408, Russian Federation
Kazan , 42002, Russian Federation
Moscow , 11547, Russian Federation
Ryazan , 39004, Russian Federation
Saint Petersburg , 19775, Russian Federation
Ufa , 45005, Russian Federation
Singapore , 16961, Singapore
Hospitalet de Llobregat Barcelona, 08908, Spain
Pozuelo de Alarcon Madrid, 28223, Spain
Barcelona , 08003, Spain
Barcelona , 08023, Spain
Barcelona , 08035, Spain
Cordoba , 14004, Spain
Madrid , 28034, Spain
Santiago de Compostela , 15706, Spain
Sevilla , 41013, Spain
Valencia , 46011, Spain
Linkoping , 581 8, Sweden
Solna , 171 6, Sweden
Umea , 901 8, Sweden
Uppsala , 751 8, Sweden
Taipei Beitou, 11217, Taiwan
Tainan , 704, Taiwan
Taipei , 100, Taiwan
Taipei , 105, Taiwan
Taipei , 11259, Taiwan
Taoyuan , 333, Taiwan
Samsun Atakum, 55280, Turkey
Adana , 01130, Turkey
Adana , 01250, Turkey
Ankara , 06100, Turkey
Ankara , 06200, Turkey
Ankara , 06510, Turkey
Antalya , 07020, Turkey
Edirne , 22030, Turkey
Istambul , 34662, Turkey
Istanbul , 34098, Turkey
Istanbul , 34365, Turkey
Istanbul , 34384, Turkey
Izmir , 35040, Turkey
Izmir , 35575, Turkey
Colchester Essex, CO4 5, United Kingdom
London , EC1M , United Kingdom
London , SW17 , United Kingdom
Maidstone , ME16 , United Kingdom
Middlesbrough , TS4 3, United Kingdom
Nottingham , NG5 1, United Kingdom
Truro , TR1 3, United Kingdom
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