Breast Cancer Clinical Trial
A Study of Atezolizumab in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel for Participants With Previously Untreated Metastatic Triple-Negative Breast Cancer (IMpassion130)
Summary
This multicenter, randomized, double-blind study evaluated the efficacy, safety, and pharmacokinetics of atezolizumab (MPDL3280A) administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC). The safety of single-agent nab-paclitaxel has been determined in previous studies of participants with mBC and the safety data to date suggest that atezolizumab can be safely combined with standard chemotherapy agents.
Eligibility Criteria
Inclusion Criteria:
Metastatic or locally advanced, histologically documented TNBC characterized by absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) expression
No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC
Eligible for taxane monotherapy (i.e., absence of rapid clinical progression, life-threatening visceral metastases, or the need for rapid symptom and/or disease control)
A representative formalin-fixed, paraffin-embedded tumor specimen in paraffin blocks, or at least 20 unstained slides with an associated pathology report documenting ER, PR, and HER2 negativity. Participants with fewer than 20 unstained slides available at baseline, and not fewer than 12 unstained slides will be eligible upon discussion with Medical Monitor
Eastern Cooperative Oncology Group performance status of 0 or 1
Measurable disease as defined by RECIST v1.1
Adequate hematologic and end-organ function
Exclusion Criteria:
Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases
Leptomeningeal disease
Pregnancy or lactation
History of autoimmune disease
Prior allogeneic stem cell or solid organ transplantation
Positive test for human immunodeficiency virus
Active hepatitis B or hepatitis C
Receipt of a live, attenuated vaccine within 4 weeks prior to randomization, during treatment, or within 5 months following the last dose of atezolizumab/placebo
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There are 243 Locations for this study
Birmingham Alabama, 35249, United States
Springdale Arkansas, 72762, United States
Oakland California, 94612, United States
Redlands California, 92373, United States
San Francisco California, 94115, United States
San Marcos California, 92069, United States
Santa Ana California, 92705, United States
Stanford California, 94305, United States
Aurora Colorado, 80014, United States
New Haven Connecticut, 06520, United States
Norwalk Connecticut, 06856, United States
Stamford Connecticut, 06904, United States
Washington District of Columbia, 20007, United States
Fort Myers Florida, 33901, United States
Jacksonville Florida, 32256, United States
Miami Beach Florida, 33140, United States
Plantation Florida, 33324, United States
Saint Petersburg Florida, 33705, United States
Marietta Georgia, 30060, United States
Chicago Illinois, 60612, United States
Baltimore Maryland, 21202, United States
Baltimore Maryland, 21287, United States
Rochville Maryland, 20850, United States
Detroit Michigan, 48201, United States
Kalamazoo Michigan, 49007, United States
Jackson Mississippi, 39202, United States
Kansas City Missouri, 64132, United States
Saint Louis Missouri, 63110, United States
Manchester New Hampshire, 03103, United States
Ridgewood New Jersey, 07450, United States
Bronx New York, 10467, United States
Lake Success New York, 11042, United States
New York New York, 10016, United States
Cincinnati Ohio, 45242, United States
Columbus Ohio, 43219, United States
Portland Oregon, 97227, United States
Portland Oregon, 97231, United States
Bethlehem Pennsylvania, 18015, United States
Pittsburgh Pennsylvania, 15213, United States
Greenville South Carolina, 29605, United States
Bristol Tennessee, 37620, United States
Germantown Tennessee, 38138, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37232, United States
El Paso Texas, 79915, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Fairfax Virginia, 22031, United States
Spokane Washington, 99204, United States
Buenos Aires , B1884, Argentina
Buenos Aires , C1125, Argentina
La Rioja , F5300, Argentina
Camperdown New South Wales, 2050, Australia
Sydney New South Wales, 2747, Australia
South Brisbane Queensland, 4101, Australia
Woolloongabba Queensland, 4102, Australia
Frankston Victoria, 3199, Australia
Melbourne Victoria, 3000, Australia
St Albans Victoria, 3021, Australia
Subiaco Western Australia, 6008, Australia
Graz , 8036, Austria
Linz , 4010, Austria
Steyr , 4400, Austria
Wien , 1090, Austria
Anderlecht , 1070, Belgium
Bruxelles , 1200, Belgium
Charleroi , 6000, Belgium
Kortrijk , 8500, Belgium
Leuven , 3000, Belgium
Wilrijk , 2610, Belgium
Sarajevo , 7100, Bosnia and Herzegovina
Salvador BA, 40050, Brazil
Fortaleza CE, 60336, Brazil
Goiania GO, 74605, Brazil
Ijui RS, 98700, Brazil
Porto Alegre RS, 90035, Brazil
Porto Alegre RS, 90610, Brazil
Florianopolis SC, 88034, Brazil
Itajai SC, 88301, Brazil
Sao Paulo SP, 01317, Brazil
Sao Paulo SP, 01321, Brazil
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Kelowna British Columbia, V1Y 5, Canada
Vancouver British Columbia, V5Z 4, Canada
Halifax Nova Scotia, B3H 2, Canada
Kingston Ontario, K7L 2, Canada
Oshawa Ontario, L1G 2, Canada
Ottawa Ontario, K2H 6, Canada
Toronto Ontario, M4N 3, Canada
Montreal Quebec, H3T 1, Canada
Quebec City Quebec, G1S 4, Canada
Santiago , 83300, Chile
Temuco , 48104, Chile
Bogota , 11001, Colombia
Monteria , 23000, Colombia
San José , 10103, Costa Rica
San José , 10108, Costa Rica
Olomouc , 779 0, Czechia
Praha 2 , 128 0, Czechia
Praha 5 , 150 0, Czechia
Tallinn , 13419, Estonia
Tartu , 51014, Estonia
Tampere , 33520, Finland
Angers , 49000, France
Avignon , 84082, France
Besancon , 25030, France
Grenoble , 38043, France
Lille , 59020, France
Lyon , 69008, France
Montpellier , 34298, France
Nantes , 44202, France
Paris , 75005, France
Paris , 75013, France
Saint Herblain , 44115, France
Strasbourg , 67000, France
Berlin , 13581, Germany
Dortmund , 44137, Germany
Dresden , 01307, Germany
Erlangen , 91054, Germany
Essen , 45122, Germany
Georgsmarienhütte , 49124, Germany
Halle , 06120, Germany
Hamburg , 20246, Germany
Hamburg , 20249, Germany
Heidelberg , 69120, Germany
Koblenz , 56068, Germany
Köln , 50935, Germany
Lübeck , 23538, Germany
München , 81675, Germany
Münster , 48153, Germany
Nordhausen , 99734, Germany
Recklinghausen , 45659, Germany
Trier , 54290, Germany
Troisdorf , 53840, Germany
Tübingen , 72076, Germany
Athens , 115 2, Greece
Athens , 155 6, Greece
Heraklion , 711 1, Greece
Patras , 265 0, Greece
Thessaloniki , 54645, Greece
Guatemala City , 01015, Guatemala
Hong Kong , , Hong Kong
Budapest , 1122, Hungary
Budapest , 1145, Hungary
Szeged , 6720, Hungary
Napoli Campania, 80131, Italy
Milano Lombardia, 20141, Italy
Aichi , 464-8, Japan
Fukushima , 960-1, Japan
Gunma , 373-8, Japan
Hiroshima , 730-8, Japan
Hiroshima , 734-8, Japan
Hokkaido , 003-0, Japan
Hyogo , 663-8, Japan
Kagoshima , 892-0, Japan
Kanagawa , 216-8, Japan
Kanagawa , 259-1, Japan
Kumamoto , 860-8, Japan
Kyoto , 606-8, Japan
Mie , 514-8, Japan
Miyagi , 980-8, Japan
Niigata , 951-8, Japan
Okayama , 700-8, Japan
Okinawa , 901-0, Japan
Osaka , 540-0, Japan
Osaka , 541-8, Japan
Osaka , 589-8, Japan
Saitama , 350-1, Japan
Saitama , 362-0, Japan
Shizuoka , 411-8, Japan
Tokyo , 104-0, Japan
Tokyo , 104-8, Japan
Tokyo , 113-8, Japan
Tokyo , 135-8, Japan
Goyang-si , 10408, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Daugavpils , 5417, Latvia
Riga , LV-10, Latvia
Cdmx Mexico CITY (federal District), 06760, Mexico
Monterrey Nuevo LEON, 66278, Mexico
Colima , 28000, Mexico
D.f. , 04980, Mexico
Mexico City , 03100, Mexico
Bergen , , Norway
Kristiansand , 4604, Norway
Stavanger , 4011, Norway
Panama , 0801, Panama
Bydgoszcz , 85-79, Poland
Gdynia , 81-51, Poland
Kraków , 30-68, Poland
Lublin , 20-09, Poland
Warszawa , 02-78, Poland
Warszawa , 04-14, Poland
Timisoara , 30023, Romania
Arkhangelsk Arhangelsk, 16304, Russian Federation
Moscovskaya Oblast Moskovskaja Oblast, 14342, Russian Federation
Moscow Moskovskaja Oblast, 10522, Russian Federation
Moskva Moskovskaja Oblast, 11547, Russian Federation
Ivanovo , 15304, Russian Federation
Kazan , 42002, Russian Federation
Saint-Petersburg , 19775, Russian Federation
Singapore , 11907, Singapore
Singapore , 16961, Singapore
Ljubljana , 1000, Slovenia
Córdoba Cordoba, 14004, Spain
Barcelona , 08003, Spain
Barcelona , 08035, Spain
Barcelona , 08907, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Malaga , 29010, Spain
Valencia , 46009, Spain
Stockholm , 118 8, Sweden
Uppsala , 751 8, Sweden
Basel , 4031, Switzerland
St. Gallen , 9007, Switzerland
Zürich , 8038, Switzerland
Kaohsiung , 807, Taiwan
Taichung , 404, Taiwan
Taipei , 00112, Taiwan
Taipei , 100, Taiwan
Bangkok , 10400, Thailand
Bangkok , 10700, Thailand
Songkhla , 90110, Thailand
Adana , 01330, Turkey
Istanbul , 34098, Turkey
Istanbul , 34214, Turkey
Izmir , 35100, Turkey
Sihhiye/Ankara , 06230, Turkey
Dnipropetrovsk , 49102, Ukraine
Kyiv , 03115, Ukraine
Lutsk , 43018, Ukraine
Lviv , 79031, Ukraine
Cardiff , CF14 , United Kingdom
Edinburgh , EH4 2, United Kingdom
London , EC1M , United Kingdom
London , SE1 9, United Kingdom
London , SW3 6, United Kingdom
Manchester , M2O 4, United Kingdom
Plymouth , PL6 8, United Kingdom
Preston , PR2 9, United Kingdom
Sheffield , S10 2, United Kingdom
Sutton , SM2 5, United Kingdom
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