AzTrials
AzTrials

Breast NeoplasmsPhase 3NCT04895358

Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49)

A Phase 3 study testing pembrolizumab, paclitaxel and nab-paclitaxel in people with Breast Neoplasms, run by Merck Sharp & Dohme LLC at 256 sites in 31 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The safety and efficacy of pembrolizumab plus the investigator's choice of chemotherapy will be assessed compared to placebo plus the investigator's choice of chemotherapy in the treatment of chemotherapy-candidate hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Neoplasms
What is being tested?
pembrolizumab, paclitaxel and nab-paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
342 participants
Where
256 sitesin 31 countries
Study dates
18 Jun 2021to 18 Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has locally recurrent inoperable or metastatic HR+/HER2- breast cancer, which has not been previously treated with cytotoxic chemotherapy in the noncurative setting
  • Has progressed on prior endocrine therapy and is now a chemotherapy candidate, meeting the characteristics in regard to previous treatments of one of the following 4 groups:
  • Group 1: Has progressed on 2 or more lines of endocrine therapy for advanced/metastatic HR+/HER2-disease, with at least given in combination with a Cyclin-dependent kinase 4/6 (CDK4/6) inhibitor. Prior treatment with mTOR and/or PI3-K inhibitors is allowed. OR
  • GROUP 2a: Has progressed on 1 line of previous endocrine therapy for advanced/metastatic disease AND had a disease recurrence within 24 months of definitive surgery for the primary tumor and while on adjuvant endocrine therapy. Prior use of CDK4/6 inhibitors is required, either in the adjuvant and/or metastatic setting. Prior treatment with mTOR and/or PI3-K inhibitors is allowed. OR
  • GROUP 2b: Has progressed within 12 months of starting 1 line of endocrine therapy with a CDK4/6 inhibitor for advanced/metastatic HR+/HER2- disease. OR
  • GROUP 3: If no prior treatment with a CDK4/6 inhibitor, for advanced/metastatic disease and/or early stage disease (adjuvant), participants must have progressed within 6 months of starting 1 line of endocrine therapy with or without an mTOR or PI3-K inhibitor for metastatic disease AND had a relapse within 24 months of definitive surgery for primary tumor and while receiving adjuvant endocrine therapy.
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  • Has presented a documented radiographic disease progression (as assessed by the investigator and/or histology [biopsy or cytology] for participants presenting with new metastatic lesions) during or after the last administered endocrine therapy prior to entering the study.
  • Is a chemotherapy candidate that meets the criteria specified in the protocol
  • Provides a new or the last obtained core biopsy, preferably consisting of multiple cores, taken from a locally recurrent or a distant (metastatic) lesion not previously irradiated
  • Has centrally confirmed PD-L1 CPS ≥1 and HR+ (estrogen receptor [ER] and/or progesterone receptor [PgR]) /HER2- breast cancer as defined by the most recent American Society of Clinical Oncology (ASCO)/(College of American Pathologists) CAP guidelines on most recent tumor biopsy
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 7 days prior to the first dose of study treatment
  • Has adequate organ function within 10 days prior to the start of study
  • Male participants must agree to the following during the treatment period and for at least 6 months after the last dose of chemotherapy: refrain from donating sperm PLUS either be abstinent from heterosexual intercourse as their preferred and usual lifestyle or use contraception and agree to use a male condom plus partner use of an additional contraceptive
  • A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (WOCBP) OR is a WOCBP and using a highly-effective contraceptive method during the treatment period and for at least 120 days after the last dose of pembrolizumab and 180 days after the last dose of chemotherapy (whichever occurs last), AND agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period
  • A WOCBP must have a negative highly sensitive pregnancy test (urine or serum) within 24 hours for urine or within 72 hours for serum before the first dose of study intervention
  • Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiologist
  • If receiving bisphosphonates or RANK ligand inhibitors, with stable doses for ≥4 weeks prior to the date of randomization, the participant may continue receiving this therapy during the study treatment. If participant needs to initiate these agents during the screening period, a bone scan to evaluate bone disease should be performed prior to randomization.
  • Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks prior to the first dose of study intervention and have undetectable HBV viral load prior to randomization
  • Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening

Who cannot join

  • Has breast cancer amenable to treatment with curative intent
  • Has a history or current evidence of any condition (e.g., transfusion-dependent anemia or thrombocytopenia), therapy, or laboratory abnormality that is specifically contraindicated per the current locally-approved labeling, that might confound the results of the study, interfere with the participant's involvement for the full duration of the study, or is not in the best interest of the participant to be involved, in the opinion of the treating investigator
  • Has significant cardiac disease, such as: history of myocardial infarction, acute coronary syndrome, coronary angioplasty/stenting/bypass within the last 6 months, congestive heart failure (CHF) New York Heart association (NYHA) Class II-IV, or history of CHF NYHA Class III or IV
  • Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications, such as lymphangitic lung metastases, bone marrow replacement, carcinomatous meningitis, significant symptomatic liver metastases, shortness of breath requiring supplemental oxygen, symptomatic pleural effusion requiring supplemental oxygen, symptomatic pericardial effusion, symptomatic peritoneal carcinomatosis, or the need to achieve rapid symptom control
  • Has skin only disease
  • Has a known germline BRCA mutation (deleterious or suspected deleterious) and has not received previous treatment with PARP inhibition. either in the adjuvant or metastatic setting (where available and not medically contraindicated). Single-agent PARP inhibitor therapy does not count as a line of endocrine therapy.
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  • Has received prior chemotherapy for locally recurrent inoperable or metastatic breast cancer
  • Has received prior therapy with an anti- programmed cell death 1 (PD-1), anti- programmed cell death ligand 1 (PD-L1), or anti- programmed cell death ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137)
  • Has received prior systemic anticancer therapy with other investigational agents within 4 weeks prior to randomization
  • Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids.
  • Has received a live or live attenuated vaccine within 30 days prior to the first dose of study intervention
  • Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ excluding cancer in situ of bladder that have undergone potentially curative therapy
  • Has known active central nervous system (CNS) metastases
  • Has diagnosed carcinomatous meningitis
  • Has severe hypersensitivity to pembrolizumab and/or any of its excipients or has any hypersensitivity to the planned chemotherapy agent (paclitaxel, nab-paclitaxel, liposomal doxorubicin, or capecitabine) and/or any of their excipients
  • Has an active autoimmune disease that has required systemic treatment in past 2 years
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • Has an active infection requiring systemic therapy
  • Has a known history of Human Immunodeficiency Virus (HIV) infection
  • Has a known COVID-19 infection (symptomatic or asymptomatic)
  • Has a known history of active tuberculosis (TB)
  • Has a known psychiatric or substance abuse disorder including alcohol or drug dependency that would interfere with the participant's ability to cooperate with the requirements of the study
  • Is breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 180 days (or longer as specified by local institutional guidelines) after the last dose of study treatment
  • Has had an allogenic tissue/solid organ transplant

Trial locations and contacts

256 sites in 31 countries.

256 sites in 31 countries

United States41 sites

  • McFarland Clinic, PC ( Site 0041)

    Ames, Iowa, 50010-3014

  • University Cancer & Blood Center, LLC ( Site 0032)

    Athens, Georgia, 30607

  • Greater Baltimore Medical Center-Medical Oncology/Hematology ( Site 0062)

    Baltimore, Maryland, 21204

  • MFSMC-HJWCI ( Site 0064)

    Baltimore, Maryland, 21237

  • MedStar Good Samaritan Hospital-Oncology Research ( Site 0069)

    Baltimore, Maryland, 21239

  • University of Alabama at Birmingham-Medicine ( Site 0065)

    Birmingham, Alabama, 35294-3300

  • Waverly Hematology Oncology ( Site 0015)

    Cary, North Carolina, 27518

  • University of Illinois at Chicago ( Site 0061)

    Chicago, Illinois, 60612

  • Henry Ford Hospital ( Site 0003)

    Detroit, Michigan, 48202

  • Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0067)

    Elmhurst, Illinois, 60126

  • Sanford Fargo Medical Center ( Site 0040)

    Fargo, North Dakota, 58102

  • Parkview Research Center at Parkview Regional Medical Center ( Site 0071)

    Fort Wayne, Indiana, 46845

  • St Francis Cancer Center ( Site 0058)

    Greenville, South Carolina, 29607

  • Baptist MD Anderson Cancer Center ( Site 0013)

    Jacksonville, Florida, 32207

  • Broome Oncology ( Site 0018)

    Johnson City, New York, 13790

  • Kadlec Clinic Hematology and Oncology ( Site 0055)

    Kennewick, Washington, 99336

  • University of Tennessee Medical Center ( Site 0039)

    Knoxville, Tennessee, 37920

  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0028)

    Marietta, Georgia, 30060

  • Miami Cancer Institute at Baptist Health, Inc. ( Site 0070)

    Miami, Florida, 33176

  • Bon Secours St. Francis Medical Center-Oncology Research ( Site 0020)

    Midlothian, Virginia, 23114

  • Pacific Cancer Care ( Site 0023)

    Monterey, California, 93940

  • Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0066)

    Naperville, Illinois, 60540

  • Hematology Oncology Associates of Rockland ( Site 0044)

    Nyack, New York, 10960

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0009)

    Omaha, Nebraska, 68130

  • Edward-Elmhurst Healthcare, Edward Hospital - Plainfield-Edward Cancer Center - Plainfield ( Site 00

    Plainfield, Illinois, 60585

  • Miami Cancer Institute - Plantation ( Site 0076)

    Plantation, Florida, 33324

  • Providence Portland Medical Center ( Site 0038)

    Portland, Oregon, 97213

  • Oregon Health and Science University ( Site 0031)

    Portland, Oregon, 97239-3011

  • UCSF Medical Center at Mission Bay ( Site 0043)

    San Francisco, California, 94158

  • New England Cancer Specialists ( Site 0007)

    Scarborough, Maine, 04074

  • Louisiana State University Health Sciences Shreveport ( Site 0072)

    Shreveport, Louisiana, 71103

  • CHRISTUS Highland-Oncology Research ( Site 0073)

    Shreveport, Louisiana, 71105

  • Sanford Cancer Center ( Site 0021)

    Sioux Falls, South Dakota, 57104

  • Orchard Healthcare Research Inc. ( Site 0037)

    Skokie, Illinois, 60077

  • Medical Oncology Associates, PS ( Site 0010)

    Spokane, Washington, 99208

  • Northwest Medical Specialties, PLLC ( Site 0008)

    Tacoma, Washington, 98405

  • Arizona Oncology Associates-Arizona Oncology ( Site 0049)

    Tucson, Arizona, 85711

  • Georgetown University Medical Center-Department of Medicine and Oncology ( Site 0026)

    Washington D.C., District of Columbia, 20007

  • MedStar Washington Hospital Center ( Site 0063)

    Washington D.C., District of Columbia, 20010

  • University of Massachusetts Medical School-Division of Hematology/Oncology ( Site 0052)

    Worcester, Massachusetts, 01655

  • North Star Lodge ( Site 0035)

    Yakima, Washington, 98902

Other trials in United States

China27 sites

  • Cancer Hospital Chinese Academy of Medical Science ( Site 2635)

    Beijing, Beijing Municipality, 100021

  • Beijing Cancer hospital-Department of Breast Cancer ( Site 2605)

    Beijing, Beijing Municipality, 100142

  • Beijing Peking Union Medical College Hospital-Medical Oncology ( Site 2610)

    Beijing, Beijing Municipality, 100730

  • Jilin Cancer Hospital-oncology department ( Site 2619)

    Changchun, Jilin, 130012

  • Xiangya Hospital Central South University-Breast department ( Site 2621)

    Changsha, Hunan, 410008

  • Hunan Cancer Hospital ( Site 2608)

    Changsha, Hunan, 410013

  • West China Hospital Sichuan University-Head and Neck Oncology ( Site 2630)

    Chengdu, Sichuan, 610041

  • The First People's Hospital of Foshan-Oncology Department of Breast Cancer ( Site 2620)

    Foshan, Guangdong, 528041

  • SUN YAT-SEN UNIVERSITY CANCER CENTRE-oncology breast ( Site 2616)

    Guangzhou, Guangdong, 510060

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Breast Oncology Center ( Site 2641)

    Guangzhou, Guangdong, 510289

  • Zhejiang Cancer Hospital-Breast Oncology ( Site 2622)

    Hangzhou, Zhejiang, 310022

  • Anhui Cancer Hospital-medical oncology ( Site 2632)

    Hefei, Anhui, 230031

  • Shandong Cancer Hospital-Breast surgery ( Site 2623)

    Jinan, Shandong, 250117

  • Taizhou Hospital of Zhejiang Province ( Site 2636)

    Linhai, Zhejiang, 317000

  • The Third Hospital of Nanchang-Oncology Dept ( Site 2628)

    Nanchang, Jiangxi, 330009

  • Jiangsu provincial people's hospital-Oncology Department ( Site 2607)

    Nanjing, Jiangsu, 210036

  • Guangxi Medical University Affiliated Tumor Hospital-Oncology Dept. of Breast and Bone Soft Tissue (

    Nanning, Guangxi, 530021

  • Fudan University Shanghai Cancer Center-Oncology ( Site 2600)

    Shanghai, Shanghai Municipality, 200032

  • Renji Hospital Shanghai Jiao Tong University School of Medicine-Breast surgery ( Site 2626)

    Shanghai, Shanghai Municipality, 200120

  • Peking University Shenzhen Hospital-Oncology Department ( Site 2601)

    Shenzhen, Guangdong, 518036

  • Tianjin Medical University Cancer Institute and Hospital-Department of Breast Cancer ( Site 2612)

    Tianjin, Tianjin Municipality, 300060

  • Xinjiang Medical University Cancer Hospital - Urumqi-galactophore department ( Site 2624)

    Ürümqi, Xinjiang, 830000

  • The First Affiliated Hospital of Wenzhou Medical University-Thyroid and breast surgery ( Site 2625)

    Wenzhou, Zhejiang, 325000

  • Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2629)

    Wuhan, Hubei, 430022

  • The First Affiliated Hospital of Xian Jiaotong University wa-Oncology ( Site 2604)

    Xi'an, Shaanxi, 710061

  • The First Affiliated hospital of Xiamen University-Breast Surgery ( Site 2613)

    Xiamen, Fujian, 361003

  • Henan Cancer Hospital-Galactophore Department ( Site 2615)

    Zhengzhou, Henan, 450003

Other trials in China

France14 sites

  • Institut de Cancérologie de l'Ouest ( Site 0915)

    Angers, Maine-et-Loire, 49055

  • CHU Besançon ( Site 0918)

    Besançon, Franche-Comte, 25000

  • Centre François Baclesse ( Site 0920)

    Caen, Calvados, 14076

  • Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne ( Site 0901)

    Clermont-Ferrand, Puy-de-Dome, 63011

  • Centre Oscar Lambret ( Site 0921)

    Lille, Nord, 59000

  • CENTRE LEON BERARD ( Site 0919)

    Lyon, Auvergne-Rhône-Alpes, 69008

  • Institut Paoli-Calmettes ( Site 0913)

    Marseille, Bouches-du-Rhone, 13009

  • Centre de Cancérologie du Grand Montpellier ( Site 0912)

    Montpellier, Languedoc-Roussillon, 34070

  • Institut Curie ( Site 0900)

    Paris, 75248

  • Centre Hospitalier Universitaire de Poitiers-Pôle régional de cancérologie ( Site 0922)

    Poitiers, Vienne, 86021

  • Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen ( Site 0904)

    Rouen, Seine-Maritime, 76038

  • Institut de Cancérologie de l'Ouest ( Site 0907)

    Saint-Herblain, Loire-Atlantique, 44805

  • Institut Claudius Regaud ( Site 0902)

    Toulouse, Haute-Garonne, 31059

  • Gustave Roussy ( Site 0914)

    Villejuif, Île-de-France Region, 94805

Other trials in France

Japan12 sites

  • Chiba University Hospital ( Site 2212)

    Chiba, 260-8677

  • National Hospital Organization Kyushu Cancer Center ( Site 2209)

    Fukuoka, 811-1395

  • Fukushima Medical University ( Site 2200)

    Fukushima, 960-1295

  • Saitama Medical University International Medical Center ( Site 2208)

    Hidaka, Saitama, 350-1298

  • St. Marianna University School of Medicine Hospital ( Site 2205)

    Kawasaki, Kanagawa, 216-8511

  • Kumamoto University ( Site 2203)

    Kumamoto, 860-8556

  • Hyogo Medical University Hospital ( Site 2201)

    Nishinomiya, Hyōgo, 663-8501

  • Kitasato University Hospital ( Site 2204)

    Sagamihara, Kanagawa, 252-0375

  • Tokyo Medical University Hospital ( Site 2206)

    Shinjuku-ku, Tokyo, 160-0023

  • Osaka University Hospital ( Site 2211)

    Suita, Osaka, 565-0871

  • St. Luke's International Hospital ( Site 2207)

    Tokyo, 104-8560

  • Juntendo University Hospital ( Site 2210)

    Tokyo, 113-8431

Other trials in Japan

Poland12 sites

  • Bialostockie Centrum Onkologii-Oddzial Onkologii Klinicznej ( Site 1812)

    Bialystok, Podlaskie Voivodeship, 15-027

  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1813)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

  • Narodowy Instytut Onkologii - Oddzial w Gliwicach-Breast Unit ( Site 1811)

    Gliwice, Silesian Voivodeship, 44-101

  • Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1815)

    Koszalin, West Pomeranian Voivodeship, 75-581

  • Pratia MCM Krakow ( Site 1809)

    Krakow, Lesser Poland Voivodeship, 30-727

  • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1819)

    Przemyśl, Podkarpackie Voivodeship, 37-700

  • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1818)

    Siedlce, Masovian Voivodeship, 08-110

  • Luxmed Onkologia sp. z o. o. ( Site 1820)

    Warsaw, Masovian Voivodeship, 01-748

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Piersi i Chirurgii (

    Warsaw, Masovian Voivodeship, 02-781

  • Lux med onkologia sp. z o.o. ( Site 1808)

    Warsaw, Masovian Voivodeship, 04-125

  • Wojskowy Instytut Medyczny-Klinika Onkologii ( Site 1803)

    Warsaw, Masovian Voivodeship, 04-141

  • Mazowiecki Szpital Onkologiczny-BREAST CANCER ( Site 1821)

    Wieliszew, Masovian Voivodeship, 05-135

Other trials in Poland

Argentina11 sites

  • Centro de Oncología e Investigación de Buenos Aires ( Site 0400)

    Berazategui, Buenos Aires, 1884

  • Hospital Aleman-Oncology ( Site 0402)

    Buenos Aires, Buenos Aires F.D., C1118AAT

  • Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0403)

    Buenos Aires, Buenos Aires F.D., C1431FWO

  • Hospital Británico de Buenos Aires-Oncology ( Site 0404)

    Ciudad Autónoma de Buenos Aires, Buenos Aires, 1280

  • Hospital Italiano de Córdoba ( Site 0409)

    Córdoba, 5000

  • Fundación CEMAIC ( Site 0410)

    Córdoba, X5008HHW

  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0412)

    Mar del Plata, Buenos Aires, B7600FZO

  • Sanatorio de La Mujer ( Site 0405)

    Rosario, Santa Fe Province, 2000

  • Sanatorio Parque ( Site 0407)

    Rosario, Santa Fe Province, S2000DSV

  • Instituto de Oncología de Rosario ( Site 0401)

    Rosario, Santa Fe Province, S2000KZE

  • Instituto San Marcos ( Site 0408)

    San Juan, J5400EBB

Other trials in Argentina

Turkey (Türkiye)11 sites

  • Baskent University Dr. Turgut Noyan Research and Training Center ( Site 2013)

    Adana, 01250

  • Hacettepe Universitesi-oncology hospital ( Site 2000)

    Ankara, 06230

  • Memorial Ankara Hastanesi-Medical Oncology ( Site 2002)

    Ankara, 06520

  • Gazi Universitesi-Oncology ( Site 2010)

    Ankara, 06560

  • ANKARA ŞEHİR HASTANESİ-Medical Oncology ( Site 2014)

    Ankara, 06800

  • Akdeniz Universitesi Hastanesi-Medical Oncology ( Site 2009)

    Antalya, 07059

  • Ege University Medicine of Faculty ( Site 2004)

    Bornova, İzmir, 35100

  • Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 2012)

    Istanbul, 34668

  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2005)

    Istanbul, 34722

  • I.E.U. Medical Point Hastanesi-Oncology ( Site 2016)

    Izmir, Karsiyaka, İzmir, 009035575

  • İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi-Medical Oncology Department

    Malatya, 44280

Other trials in Turkey (Türkiye)

Italy9 sites

  • Instituto Tumori Giovanni Paolo II-ONCOLOGIA MEDICA ( Site 1112)

    Bari, 70124

  • Ospedale Cannizzaro ( Site 1118)

    Catania, 95126

  • Ospedale San Raffaele-Oncologia Medica ( Site 1110)

    Milan, Lombardy, 20132

  • Istituto Europeo di Oncologia IRCCS-Divisione di Senologia Medica ( Site 1111)

    Milan, 20141

  • Ospedale San Gerardo-ASST Monza-Research Unit Phase 1 ( Site 1115)

    Monza, Lombardy, 20900

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1116)

    Naples, 80131

  • Istituto Oncologico Veneto IRCCS ( Site 1117)

    Padova, 35128

  • Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 1113)

    Rome, Lazio, 00168

  • Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1114)

    Rozzano, Milano, 20089

Other trials in Italy

Netherlands9 sites

  • Jeroen Bosch Hospital ( Site 1359)

    's-Hertogenbosch, North Brabant, 5223 GZ

  • Meander Medisch Centrum ( Site 1358)

    Amersfoort, Utrecht, 3813TZ

  • Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) ( Site 1351)

    Amsterdam, North Holland, 1066 CX

  • Leids Universitair Medisch Centrum-Medical Oncology ( Site 1356)

    Leiden, South Holland, 2333 ZA

  • Haaglanden MC - locatie Antoniushove-Medical oncology ( Site 1355)

    Leidschendam, South Holland, 2501 ck

  • Maastricht UMC+-Medical Oncology ( Site 1353)

    Maastricht, Limburg, 6229 HX

  • Radboudumc-Medical Oncology ( Site 1360)

    Nijmegen, Gelderland, 6525 GA

  • Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 1354)

    Schiedam, South Holland, 3118JH

  • Elisabeth-TweeSteden Ziekenhuis-Internal Medicine ( Site 1357)

    Tilburg, North Brabant, 5022 GC

Other trials in Netherlands

Russia9 sites

  • Arkhangelsk Clinical Oncological Dispensary-Chemotherapy department ( Site 1902)

    Arkhangelsk, Arkhangelskaya oblast, 163045

  • Moscow Clinical Research Center-Chemotherapy department ( Site 1903)

    Moscow, Moscow, 111123

  • Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology MHRF ( Site 1901)

    Moscow, Moscow, 115478

  • Central Clinical Hospital of the Presidential Administrative Department ( Site 1904)

    Moscow, Moscow, 121359

  • Nizhegorodsky Regional Oncology Dispensary-chemotherapy ( Site 1912)

    Nizhny Novgorod, Nizhny Novgorod Oblast, 603081

  • Podolsk Regional Clinical Hospital ( Site 1907)

    Podolsk, Moscow Oblast, 142110

  • Ryazan Regional Clinical Oncology Center-Oncology #1 ( Site 1906)

    Ryazan, Ryazan Oblast, 390046

  • St. Petersburg Clinical Hospital of Russian Academy Of Sciences-Medical Oncology ( Site 1905)

    Saint Petersburg, Sankt-Peterburg, 194017

  • N.N.Petrov Research Institute of Oncology ( Site 1900)

    Saint Petersburg, Sankt-Peterburg, 197758

Other trials in Russia

Canada7 sites

  • Tom Baker Cancer Center ( Site 0107)

    Calgary, Alberta, T2N 4N2

  • Centre Hospitalier de l'Université de Montréal ( Site 0105)

    Montreal, Quebec, H2X 3E4

  • Jewish General Hospital ( Site 0110)

    Montreal, Quebec, H3T 1E2

  • Hopital Du Saint-Sacrement ( Site 0109)

    Québec, Quebec, G1S 4L8

  • North York General Hospital ( Site 0108)

    Toronto, Ontario, M2K 1E1

  • Princess Margaret Cancer Centre ( Site 0101)

    Toronto, Ontario, M5G 2M9

  • Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec (

    Trois-Rivières, Quebec, G8Z 3R9

Other trials in Canada

United Kingdom7 sites

  • Blackpool Victoria Hospital ( Site 1503)

    Blackpool, Lancashire, FY38NR

  • Leicester Royal Infirmary-HOPE Clinical Trials Unit ( Site 1502)

    Leicester, England

  • St Bartholomew's Hospital ( Site 1508)

    London, England, EC1A 7BE

  • Guy's & St Thomas' NHS Foundation Trust ( Site 1501)

    London, London, City of, SE1 9RT

  • North West Cancer Centre ( Site 1511)

    Londonderry, London, City of, BT47 6SB

  • The Christie ( Site 1510)

    Manchester, England, M20 4BX

  • The Royal Cornwall Hospital ( Site 1507)

    Truro, Cornwall, TR1 3LJ

Other trials in United Kingdom

Brazil6 sites

  • Clínica de Oncologia Reichow ( Site 0210)

    Blumenau, Santa Catarina, 89010-340

  • YNOVA Pesquisa Clínica ( Site 0203)

    Florianópolis, Santa Catarina, 88020210

  • Hospital de Câncer de Recife ( Site 0211)

    Recife, Pernambuco, 50040-000

  • Instituto Nacional de Câncer - INCA-Pesquisa Clinica HC3 ( Site 0208)

    Rio de Janeiro, 20560121

  • Instituto de Educação, Pesquisa e Gestão em Saúde ( Site 0202)

    Rio de Janeiro, 20775-001

  • Instituto de Oncologia Saint Gallen ( Site 0206)

    Santa Cruz do Sul, Rio Grande do Sul, 96830-180

Other trials in Brazil

Chile6 sites

  • FALP ( Site 0501)

    Santiago, Region M. de Santiago, 7500921

  • Oncovida ( Site 0514)

    Santiago, Region M. de Santiago, 7510032

  • Clínica RedSalud Vitacura ( Site 0515)

    Santiago, Region M. de Santiago, 7650018

  • Instituto Nacional del Cancer-CR Investigación ( Site 0511)

    Santiago, Region M. de Santiago, 8380455

  • Bradfordhill ( Site 0500)

    Santiago, Region M. de Santiago, 8420383

  • Centro Investigación del Cáncer James Lind ( Site 0513)

    Temuco, Araucania, 4800827

Other trials in Chile

Colombia6 sites

  • Clinica de la Costa S.A.S. ( Site 0601)

    Barranquilla, Atlántico, 080020

  • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia ( Site 0607)

    Bogotá, Bogota D.C., 111321

  • Fundación Colombiana de Cancerología Clínica Vida ( Site 0605)

    Medellín, Antioquia, 050021435

  • Instituto de Cancerología-Oncology ( Site 0606)

    Medellín, Antioquia, 050024

  • Oncomedica S.A.-Oncomedica S.A ( Site 0604)

    Montería, Departamento de Córdoba, 230002

  • Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 0603)

    Valledupar, Cesar Department, 200001

Other trials in Colombia

Germany6 sites

  • Vivantes Klinikum Am Urban-Haematologie und Onkologie ( Site 1203)

    Berlin, 10967

  • Gynaekologisches Zentrum Bonn ( Site 1201)

    Bonn, North Rhine-Westphalia, 53111

  • Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und Gebur

    Dresden, Saxony, 01307

  • Universitaetsklinikum Duesseldorf-Klinik für Frauenheilkunde & Geburtshilfe ( Site 1204)

    Düsseldorf, North Rhine-Westphalia, 40225

  • Universitaetsklinikum Erlangen-Klinik für Gynäkologie und Geburtshilfe ( Site 1202)

    Erlangen, Bavaria, 91054

  • Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung-Klinike für Senologie/ Brustzentrum ( Site 1200

    Essen, North Rhine-Westphalia, 45136

Other trials in Germany

South Korea6 sites

  • National Cancer Center-Center for Breast Cancer ( Site 2404)

    Goyang-si, Kyonggi-do, 10408

  • Seoul National University Bundang Hospital ( Site 2406)

    Seongnam, Kyonggi-do, 13620

  • Seoul National University Hospital-Internal Medicine ( Site 2403)

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System ( Site 2400)

    Seoul, 03722

  • Asan Medical Center ( Site 2402)

    Seoul, 05505

  • Samsung Medical Center-Division of Hematology/Oncology ( Site 2401)

    Seoul, 06351

Other trials in South Korea

Austria5 sites

  • Medizinische Universität Graz-Innere Medizin Klin. Abt. Onkologie ( Site 1609)

    Graz, Styria, 8036

  • Medizinische Universitaet Innsbruck ( Site 1602)

    Innsbruck, Tyrol, 6020

  • Uniklinikum Salzburg-Universitätsklinik für Innere Medizin III der PMU mit Hämatologie, internistis

    Salzburg, 5020

  • Medizinische Universität Wien ( Site 1601)

    Vienna, State of Vienna, 1090

  • Landesklinikum Wiener Neustadt-Innere Medizin, Hämatologie und internistische Onkologie ( Site 1604)

    Wiener Neustadt, Lower Austria, 2700

Other trials in Austria

Greece5 sites

  • General Hospital of Athens Laiko-First Department of Internal Medicine ( Site 0305)

    Athens, Attica, 115 26

  • Alexandra Hospital-ONCOLGOY DEPT. ( Site 0302)

    Athens, Attica, 115 28

  • University General Hospital of Heraklion-Internal Medicine-Oncology ( Site 0303)

    Heraklion, Irakleio, 715 00

  • Hygeia Hospital-3rd Oncology Department ( Site 0304)

    Marousi, Attica, 151 23

  • Euromedica General Clinic Thessaloniki-Oncology Unit ( Site 0301)

    Thessaloniki, 546 45

Other trials in Greece

Israel5 sites

  • Assuta Ashdod Medical Center ( Site 1703)

    Ashdod, 7747629

  • Soroka Medical Center-Oncology ( Site 1702)

    Beersheba, 8400000

  • Bnai Zion Medical Center-Oncology ( Site 1704)

    Haifa, 3339419

  • Sheba Medical Center-ONCOLOGY ( Site 1700)

    Ramat Gan, 5265601

  • Sourasky Medical Center-Oncology ( Site 1701)

    Tel Aviv, 6423906

Other trials in Israel

Malaysia5 sites

  • Hospital Pulau Pinang ( Site 2504)

    George Town, Pulau Pinang, 10990

  • Hospital Kuala Lumpur-Radiotherapy and Oncology ( Site 2506)

    Kuala Lumpur, 50586

  • Pantai Hospital Kuala Lumpur-Cancer Centre ( Site 2503)

    Kuala Lumpur, 59100

  • Sarawak General Hospital-Radiotherapy Unit ( Site 2501)

    Kuching, Sarawak, 93586

  • University Malaya Medical Centre ( Site 2505)

    Lembah Pantai, Kuala Lumpur, 59100

Other trials in Malaysia

Mexico5 sites

  • Centro Estatal de Cancerologia-Investigación ( Site 0256)

    Chihuahua City, 31000

  • Hospital Civil Fray Antonio Alcalde-Oncology ( Site 0262)

    Guadalajara, Jalisco, 44280

  • Samadhi Centro Oncológico ( Site 0258)

    Mexico City, Mexico City, 04739

  • Filios Alta Medicina ( Site 0253)

    Monterrey, Nuevo León, 64460

  • Centro de Investigacion Clinica de Oaxaca ( Site 0252)

    Oaxaca City, 68020

Other trials in Mexico

Portugal5 sites

  • Champalimaud Foundation ( Site 1006)

    Lisbon, Lisbon District, 1400-038

  • Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria ( Site 1004)

    Lisbon, Lisbon District, 1649-035

  • UNIDADE LOCAL DE SAUDE DE MATOSINHOS ( Site 1007)

    Matosinhos Municipality, Porto District, 4464-513

  • Centro Hospitalar do Porto - Hospital de Santo António-Oncology Service ( Site 1003)

    Porto, 4099-001

  • Instituto Português de Oncologia do Porto Francisco Gentil, EPE ( Site 1005)

    Porto, 4200-072

Other trials in Portugal

Romania5 sites

  • Oncopremium Team-Oncology ( Site 2903)

    Baia Mare, Maramureş, 430291

  • Cardiomed SRL Cluj-Napoca ( Site 2902)

    Cluj-Napoca, Cluj, 400015

  • Institutul Oncologic-Day Hospital Unit ( Site 2905)

    Cluj-Napoca, Cluj, 400015

  • Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2901)

    Craiova, Dolj, 200542

  • Sigmedical Services SRL ( Site 2904)

    Suceava, 720214

Other trials in Romania

Spain5 sites

  • Hospital Quiron Barcelona ( Site 1326)

    Barcelona, Catalonia, 08023

  • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1333)

    Madrid, Madrid, Comunidad de, 28007

  • Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1320)

    Madrid, Madrid, Comunidad de, 28034

  • HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1323)

    Pozuelo de Alarcón, Madrid, 28223

  • Fundación Instituto Valenciano de Oncología-Oncologico ( Site 1332)

    Valencia, Valenciana, Comunitat, 46009

Other trials in Spain

Australia4 sites

  • Frankston Hospital-Oncology and Haematology ( Site 2103)

    Frankston, Victoria, 3199

  • Macquarie University-MQ Health Clinical Trials Unit ( Site 2102)

    Macquarie Park, New South Wales, 2109

  • Breast Cancer Research Centre-WA ( Site 2104)

    Nedlands, Western Australia, 6009

  • Westmead Hospital-Department of Medical Oncology ( Site 2101)

    Westmead, New South Wales, 2145

Other trials in Australia

Guatemala4 sites

  • CELAN,S.A ( Site 0151)

    Guatemala City, 01010

  • Gastrosoluciones ( Site 0156)

    Guatemala City, 01010

  • INTEGRA Cancer Institute ( Site 0155)

    Guatemala City, 01010

  • Centro Medico Integral De Cancerología (CEMIC) ( Site 0154)

    Quetzaltenango, 09002

Other trials in Guatemala

Hungary3 sites

  • Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2804)

    Kecskemét, Bács-Kiskun county, 6000

  • Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 2807)

    Pécs, Baranya, 7624

  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Onkoterapias Klinika ( Site 2805)

    Szeged, Csongrád megye, 6725

Other trials in Hungary

Ireland2 sites

  • St. James's Hospital ( Site 1530)

    Dublin, D08 E9P6

  • St. Vincent's University Hospital-Medical Oncology Research Department ( Site 1531)

    Dublin, D4 YN63

Other trials in Ireland

Philippines2 sites

  • East Avenue Medical Center ( Site 0802)

    Quezon City, National Capital Region, 1500

  • CARDINAL SANTOS MEDICAL CENTER-Research Room ( Site 0800)

    San Juan City, National Capital Region, 1502

Other trials in Philippines

Sweden2 sites

  • Södra Älvsborg Sjukhus ( Site 1406)

    Borås, Västra Götaland County, 501 82

  • Karolinska Universitetssjukhuset Solna-Tema Cancer - ME Bröst- endokrina tumörer och sarkom ( Site 1

    Stockholm, Stockholm County, 171 76

Other trials in Sweden

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Locally Recurrent Inoperable or Metastatic Breast Cancer (KEYNOTE-B49)

The safety and efficacy of pembrolizumab plus the investigator's choice of chemotherapy will be assessed compared to placebo plus the investigator's choice of chemotherapy in the treatment of chemotherapy-candidate hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) locally recurrent inoperable or metastatic breast cancer.

The primary hypotheses are that the combination of pembrolizumab and chemotherapy is superior to placebo and chemotherapy in regards to Progression-Free Survival (PFS) in participants with programmed cell death-ligand 1 (PD-L1) combined positive score (CPS) ≥1.

Prior to protocol amendment 7, participants who discontinued pembrolizumab/placebo with SD or better and subsequently experienced disease progression may have been eligible for up to 17 additional administrations of pembrolizumab if, upon unblinding, they were found to have received pembrolizumab, at the same dose and schedule used for the initial treatment period.

Being tested
pembrolizumab, paclitaxel, nab-paclitaxel, liposomal doxorubicin, capecitabine
Keywords
programmed cell death receptor 1 (PD-1, PD1), programmed cell death receptor ligand 1 (PD-L1, PDL1), programmed cell death receptor ligand 2 (PD-L2, PDL2), human epidermal growth factor 2 negative (HER2-), hormone receptor positive (HR+), estrogen receptor positive (ER+), progesterone receptor positive (PR+), metastatic, inoperable
Medical subject headings
Breast Neoplasms, Parkinson Disease 4, Autosomal Dominant Lewy Body, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pembrolizumabBiological

    Also called KEYTRUDA®, MK-3475

    Intravenous (IV) infusion

  • paclitaxelDrug

    Also called TAXOL®

    IV infusion

  • nab-paclitaxelDrug

    Also called ABRAXANE®

    IV infusion

  • liposomal doxorubicinDrug

    Also called DOXIL®

    IV infusion

  • capecitabineDrug

    Also called XELODA®

    oral administration

  • normal salineDrug

    IV infusion

  • dextroseDrug

    IV infusion

Study groups in NCT04895358
Study groupRoleWhat they receive
Pembrolizumab + ChemotherapyExperimentalParticipants receive pembrolizumab 200 mg administered by intravenous infusion (IV) on Day 1 of each 21-day cycle (Q3W) PLUS one of four chemotherapy regimens: 1) paclitaxel 90 mg/m^2 IV on Days 1, 8, and 15 of each 28-day cycle (Q4W), 2) nab-paclitaxel 100 mg/m^2 IV on Days 1, 8, and 15 Q4W, 3) liposomal doxorubicin 50 mg/m^2 IV on Day 1 Q4W, OR 4) capecitabine 1000 mg/m^2 by oral administration (PO) twice a day (BID) on Days 1-14 Q3W for up to 35 administrations.
Receives: Biological: pembrolizumab; Drug: paclitaxel; Drug: nab-paclitaxel; Drug: liposomal doxorubicin; Drug: capecitabine
Placebo + ChemotherapyActive comparatorParticipants receive placebo (normal saline or dextrose) IV on Day 1 Q3W PLUS one of four chemotherapy regimens: 1) paclitaxel 90 mg/m^2 IV on Days 1, 8, and 15 Q4W, 2) nab-paclitaxel 100 mg/m^2 IV on Days 1, 8, and 15 Q4W, 3) liposomal doxorubicin 50 mg/m^2 IV on Day 1 Q4W, OR 4) capecitabine 1000 mg/m^2 PO BID on Days 1-14 Q3W for up to 35 administrations.
Receives: Drug: paclitaxel; Drug: nab-paclitaxel; Drug: liposomal doxorubicin; Drug: capecitabine; Drug: normal saline; Drug: dextrose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥1

    PFS is defined as the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The PFS in participants with a CPS of ≥1, as assessed by BICR, will be presented.

    Measured: Up to approximately 50 months

Secondary outcomes (33)

  1. Overall Survival (OS) in Participants With Combined Positive Score (CPS) ≥1

    OS is defined as the time from randomization to death due to any cause. OS for participants with a CPS of ≥1 will be presented.

    Measured: Up to approximately 76 months

  2. Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥10

    PFS is defined as the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The PFS in participants with a CPS of ≥10, as assessed by BICR, will be presented.

    Measured: Up to approximately 76 months

  3. OS in Participants With CPS ≥10

    OS is defined as the time from randomization to death due to any cause. OS for participants with a CPS of ≥10 will be presented.

    Measured: Up to approximately 76 months

  4. Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Investigator in Participants With Combined Positive Score (CPS) ≥10

    PFS is defined as the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The PFS in participants with a CPS of ≥10, as assessed by investigator, will be presented.

    Measured: Up to approximately 76 months

  5. Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Investigator in Participants With Combined Positive Score (CPS) ≥1

    PFS is defined as the time from randomization to the first documented disease progression (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The PFS in participants with a CPS of ≥1, as assessed by investigator, will be presented.

    Measured: Up to approximately 76 months

  6. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥10

    ORR is defined as the percentage of participants in the analysis population who achieve confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. ORR for participants with a CPS of ≥10 will be presented.

    Measured: Up to approximately 76 months

  7. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥1

    ORR is defined as the percentage of participants in the analysis population who achieve confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. ORR for participants with a CPS of ≥1 will be presented.

    Measured: Up to approximately 76 months

  8. Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥10

    DCR is defined as the percentage of participants who achieve Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions), or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD]) for at least 24 weeks. The percentage of participants who experience a confirmed CR, PR, or SD with a CPS of ≥10 will be presented.

    Measured: Up to approximately 76 months

  9. Disease Control Rate (DCR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥1

    DCR is defined as the percentage of participants who achieve Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions), or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD]) for at least 24 weeks. The percentage of participants who experience a confirmed CR, PR, or SD with a CPS of ≥1 will be presented.

    Measured: Up to approximately 76 months

  10. Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥10

    For participants who demonstrate CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), DOR is defined as the time from the first documented evidence of CR or PR until disease progression (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, or death from any cause, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. DOR for participants with a CPS of ≥10 will be presented.

    Measured: Up to approximately 76 months

  11. Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥1

    For participants who demonstrate CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), DOR is defined as the time from the first documented evidence of CR or PR until disease progression (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, or death from any cause, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. DOR for participants with a CPS of ≥1 will be presented.

    Measured: Up to approximately 76 months

  12. Change From Baseline in Global Health Status/Quality of Life Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10

    The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to the questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and Quality of Life (QoL; "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in GHS (EORTC QLQ-C30 Item 29) and QoL (EORTC QLQ-C30 Item 30) combined score will be presented in participants with a CPS of ≥10. A higher score indicates a better outcome.

    Measured: Baseline and up to approximately 76 months

  13. Change From Baseline in Global Health Status/Quality of Life Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1

    The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to the questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and Quality of Life (QoL; "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in GHS (EORTC QLQ-C30 Item 29) and QoL (EORTC QLQ-C30 Item 30) combined score will be presented in participants with a CPS of ≥1. A higher score indicates a better outcome.

    Measured: Baseline and up to approximately 76 months

  14. Change From Baseline in Physical Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10

    The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning (Items 1-5) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the physical functioning score will be presented in participants with a CPS of ≥10. A higher score indicates a better level of function.

    Measured: Baseline and up to approximately 76 months

  15. Change From Baseline in Physical Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1

    The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning (Items 1-5) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the physical functioning score will be presented in participants with a CPS of ≥1. A higher score indicates a better level of function.

    Measured: Baseline and up to approximately 76 months

  16. Change From Baseline in Emotional Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10

    The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 4 questions about their emotional functioning (Items 21-24) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the emotional functioning score will be presented in participants with a CPS of ≥10. A higher score indicates a better level of function.

    Measured: Baseline and up to approximately 76 months

  17. Change From Baseline in Emotional Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1

    The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 4 questions about their emotional functioning (Items 21-24) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the emotional functioning score will be presented in participants with a CPS of ≥1. A higher score indicates a better level of function.

    Measured: Baseline and up to approximately 76 months

  18. Change From Baseline in Fatigue Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10

    The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 3 questions about their fatigue (Items 10, 12, 18) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the fatigue score will be presented in participants with a CPS of ≥10. A lower score indicates a better outcome.

    Measured: Baseline and up to approximately 76 months

  19. Change From Baseline in Fatigue Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1

    The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 3 questions about their fatigue (Items 10, 12, 18) are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the fatigue score will be presented in participants with a CPS of ≥1. A lower score indicates a better outcome.

    Measured: Baseline and up to approximately 76 months

  20. Change From Baseline in Diarrhea Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10

    The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire, including a single-item scale score for diarrhea (QLQ-C30 Item 17). For this item, individual responses to the question "Have you had diarrhea?" are given on a 4-point scale (1=Not at all; 4=Very much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the diarrhea score will be presented in participants with a CPS of ≥10. A lower score indicates a better outcome.

    Measured: Baseline and up to approximately 76 months

  21. Change From Baseline in Diarrhea Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1

    The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire, including a single-item scale score for diarrhea (QLQ-C30 Item 17). For this item, individual responses to the question "Have you had diarrhea?" are given on a 4-point scale (1=Not at all; 4=Very much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in the diarrhea score will be presented in participants with a CPS of ≥1. A lower score indicates a better outcome.

    Measured: Baseline and up to approximately 76 months

  22. Time to Deterioration (TTD) in Global Health Status/Quality of Life Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10

    TTD is defined as the time to the first onset of a ≥10-point deterioration (decrease) from baseline in Global Health Status (GHS; EORTC QLQ-C30 Item 29) \& Quality of Life (QoL; EORTC QLQ-C30 Item 30) combined score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point deterioration (decrease) from baseline in GHS and QoL combined score, will be presented in participants with a CPS of ≥10. A longer TTD indicates a better outcome.

    Measured: Up to approximately 76 months

  23. Time to Deterioration (TTD) in Global Health Status/Quality of Life Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1

    TTD is defined as the time to the first onset of a ≥10-point deterioration (decrease) from baseline in Global Health Status (GHS; EORTC QLQ-C30 Item 29) \& Quality of Life (QoL; EORTC QLQ-C30 Item 30) combined score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point deterioration (decrease) from baseline in GHS and QoL combined score, will be presented in participants with a CPS of ≥1. A longer TTD indicates a better outcome.

    Measured: Up to approximately 76 months

  24. Time to Deterioration (TTD) in Physical Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10

    TTD is defined as the time to the first onset of a ≥10-point deterioration (decrease) from baseline in physical functioning score (EORTC QLQ-C30 Items 1-5). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point deterioration (decrease) from baseline in physical functioning score, will be presented in participants with a CPS of ≥10. A longer TTD indicates a better outcome.

    Measured: Up to approximately 76 months

  25. Time to Deterioration (TTD) in Physical Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1

    TTD is defined as the time to the first onset of a ≥10-point deterioration (decrease) from baseline in physical functioning score (EORTC QLQ-C30 Items 1-5). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point deterioration (decrease) from baseline in physical functioning score, will be presented in participants with a CPS of ≥1. A longer TTD indicates a better outcome.

    Measured: Up to approximately 76 months

  26. Time to Deterioration (TTD) in Diarrhea Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10

    TTD is defined as the time to the first onset of a ≥10-point deterioration (decrease) from baseline in diarrhea score (EORTC QLQ-C30 Item 17). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point deterioration (decrease) from baseline in diarrhea score, will be presented in participants with a CPS of ≥10. A longer TTD indicates a better outcome.

    Measured: Up to approximately 76 months

  27. Time to Deterioration (TTD) in Emotional Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10

    TTD is defined as the time to the first onset of a ≥10-point deterioration (decrease) from baseline in emotional functioning score (EORTC QLQ-C30 Items 21-24). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point deterioration (decrease) from baseline in emotional functioning score, will be presented in participants with a CPS of ≥10. A longer TTD indicates a better outcome.

    Measured: Up to approximately 76 months

  28. Time to Deterioration (TTD) in Emotional Functioning Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1

    TTD is defined as the time to the first onset of a ≥10-point deterioration (decrease) from baseline in emotional functioning score (EORTC QLQ-C30 Items 21-24). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point deterioration (decrease) from baseline in emotional functioning score, will be presented in participants with a CPS of ≥1. A longer TTD indicates a better outcome.

    Measured: Up to approximately 76 months

  29. Time to Deterioration (TTD) in Fatigue Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥10

    TTD is defined as the time to the first onset of a ≥10-point deterioration (decrease) from baseline in fatigue score (EORTC QLQ-C30 Items 10, 12, 18). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point deterioration (decrease) from baseline in fatigue score, will be presented in participants with a CPS of ≥10. A longer TTD indicates a better outcome.

    Measured: Up to approximately 76 months

  30. Time to Deterioration (TTD) in Fatigue Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1

    TTD is defined as the time to the first onset of a ≥10-point deterioration (decrease) from baseline in fatigue score (EORTC QLQ-C30 Items 10, 12, 18). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point deterioration (decrease) from baseline in fatigue score, will be presented in participants with a CPS of ≥1. A longer TTD indicates a better outcome.

    Measured: Up to approximately 76 months

  31. Time to Deterioration (TTD) in Diarrhea Score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in Participants with CPS ≥1

    TTD is defined as the time to the first onset of a ≥10-point deterioration (decrease) from baseline in diarrhea score (EORTC QLQ-C30 Item 17). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point deterioration (decrease) from baseline in diarrhea score, will be presented in participants with a CPS of ≥1. A longer TTD indicates a better outcome.

    Measured: Up to approximately 76 months

  32. Percentage of Participants who Experience an Adverse Event (AE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience one or more adverse events will be presented.

    Measured: Up to approximately 76 months

  33. Percentage of Participants who Discontinue Study Drug due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study treatment due to an adverse event will be presented.

    Measured: Up to approximately 76 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2021
  2. Study start18 Jun 2021
  3. Primary completion24 Apr 2026
  4. Study completion18 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
342 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04895358
Sponsor's protocol ID
3475-B49
Other IDs
MK-3475-B49, KEYNOTE-B49, 2023-506752-24-00, U1111-1294-3354, jRCT2051210049, PHRR210721-003751, 2020-005407-38, 2023
Status last verified
Jul 2026
First submitted
17 May 2021
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Rugo HS, Kok M, Goncalves A, Loirat D, Bianchini G, Fasching PA, Cescon DW, Diaz RR, Zagouri F, Korbenfeld E, Dalenc F, Gilarranz YJ, Hashimoto J, Park YH, Im SA, Hu X, Hirshfield KM, Jia L, Tryfonidis K, Schmid P. Pembrolizumab Plus Chemotherapy for HR+/HER2- PD-L1-Positive Advanced Breast Cancer: Final Analysis of the Phase 3 KEYNOTE-B49 Study. Ann Oncol. 2026 Oct 24:S0923-7534(26)08077-4. doi: 10.1016/j.annonc.2026.10.1285. Online ahead of print.

    PubMed 42926111

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pembrolizumab, paclitaxel and nab-paclitaxel in people with Breast Neoplasms, run by Merck Sharp & Dohme LLC at 256 sites in 31 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 256 sites in United States, China, France, Japan, Poland and 26 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) in Participants With Combined Positive Score (CPS) ≥1 (time frame: Up to approximately 50 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04895358, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

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