Breast Cancer Clinical Trial
A Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy
Summary
This is a Phase III, two-arm, randomized, double-blind placebo-controlled study in participants with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease in the breast and/or axillary lymph nodes.
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed invasive breast carcinoma
Centrally-confirmed human epidermal growth factor receptor 2 (HER2)-positive invasive breast cancer
Centrally confirmed PD-L1 and hormone receptor status
Clinical stage at disease presentation (prior to neoadjuvant therapy): cT4/anyN/M0, any cT/N2-3/M0, or cT1-3/N0-1/M0 (participants with cT1mi/T1a/T1b/N0 are not eligible)
Completion of pre-operative systemic chemotherapy including at least 9 weeks of taxane and 9 weeks of trastuzumab (anthracycline and/or additional HER2-targeted agents are permitted)
<=12 weeks between primary surgery and randomization
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
Screening left ventricular ejection fraction (LVEF) >= 50% and no decrease in LVEF by >15% from the pre-chemotherapy LVEF. If no pre-chemotherapy LVEF, screening LVEF >= 55%
Life expectancy >= 6 months
Adequate hematologic and end organ function
Exclusion Criteria:
Stage IV breast cancer
An overall response of disease progression according to the investigator at the conclusion of preoperative systemic therapy
Prior treatment with T-DM1, or atezolizumab, or other immune checkpoint inhibitors
History of exposure to various cumulative doses of anthracyclines
History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or ductal carcinoma in situ (DCIS)
Current grade >=2 peripheral neuropathy
History of idiopathic pulmonary fibrosis, organizing pneumonia, or pneumonitis
History of or active autoimmune disease or immune deficiency
Treatment with immunostimulatory or immunosuppressive agents
Cardiopulmonary dysfunction
Any known active liver disease
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There are 300 Locations for this study
Alabaster Alabama, 35007, United States
Burbank California, 91505, United States
Fresno California, 93720, United States
Glendale California, 91206, United States
Santa Monica California, 90404, United States
Whittier California, 90603, United States
Jacksonville Florida, 32256, United States
West Palm Beach Florida, 33401, United States
Athens Georgia, 30607, United States
Carrollton Georgia, 30117, United States
Elmhurst Illinois, 60126, United States
Naperville Illinois, 60540, United States
Plainfield Illinois, 60585, United States
Iowa City Iowa, 52242, United States
Covington Louisiana, 70433, United States
Scarborough Maine, 04074, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21202, United States
Detroit Michigan, 48202, United States
Jackson Mississippi, 39202, United States
Bolivar Missouri, 65613, United States
Camden New Jersey, 08103, United States
Camden New Jersey, 08103, United States
Neptune New Jersey, 07753, United States
Paramus New Jersey, 07652, United States
New York New York, 10029, United States
Williamsville New York, 14221, United States
Asheville North Carolina, 28806, United States
Portland Oregon, 97213, United States
Philadelphia Pennsylvania, 19106, United States
Wynnewood Pennsylvania, 19096, United States
Charleston South Carolina, 29414, United States
Sioux Falls South Dakota, 57105, United States
Chattanooga Tennessee, 37404, United States
Germantown Tennessee, 38138, United States
Knoxville Tennessee, 37916, United States
Nashville Tennessee, 37203, United States
Lubbock Texas, 79410, United States
San Antonio Texas, 78229, United States
Fredericksburg Virginia, 22408, United States
Newport News Virginia, 23606, United States
Norfolk Virginia, 23502, United States
Richmond Virginia, 23229, United States
Virginia Beach Virginia, 23456, United States
Everett Washington, 98201, United States
Kennewick Washington, 99336, United States
Tacoma Washington, 98405, United States
Campbelltown New South Wales, 2560, Australia
Darlinghurst New South Wales, 2010, Australia
St Leonards New South Wales, 2065, Australia
Woolloongabba Queensland, 4102, Australia
Melbourne Victoria, 3000, Australia
Innsbruck , 6020, Austria
Linz , 4010, Austria
Salzburg , 5020, Austria
Vienna , 1090, Austria
Bruxelles , 1200, Belgium
Hasselt , 3500, Belgium
Namur , 5000, Belgium
Salvador BA, 41253, Brazil
Fortaleza CE, 60336, Brazil
Goiania GO, 74605, Brazil
Porto Alegre RS, 91350, Brazil
Sao Jose do Rio Preto SP, 15090, Brazil
Sao Paulo SP, 01317, Brazil
Sao Paulo SP, 04014, Brazil
Plovdiv , 4004, Bulgaria
Sofia , 1330, Bulgaria
Sofia , 1527, Bulgaria
Chengdu City , 61004, China
Chengdu City , 61004, China
Chongqing , 40003, China
Guangzhou City , 51008, China
Guangzhou City , 51018, China
Guangzhou , 51000, China
Harbin , 15008, China
Shanghai , 20003, China
Tianjing , 30006, China
Wuhan City , 43002, China
Xi'an , 71006, China
Zhejiang , 31002, China
Zhengzhou , 45000, China
Brno , 656 5, Czechia
Hradec Kralove , 500 0, Czechia
Novy Jicin , 741 0, Czechia
Olomouc , 779 0, Czechia
Praha 2 , 128 0, Czechia
Praha 4 - Krc , 140 5, Czechia
Praha 5 , 150 0, Czechia
Herlev , 2730, Denmark
Vejle , 7100, Denmark
Avignon , 84082, France
Besançon , 25030, France
Bordeaux , 33300, France
Brest , 29200, France
Caen , 14076, France
Creil Cedex 1 , 60109, France
Lyon , 69008, France
Nimes , 30029, France
Paris , 75020, France
Paris , 75231, France
Poitiers , 86021, France
Saint-Cloud , 92210, France
Augsburg , 86156, Germany
Aurich , 26603, Germany
Bad Homburg vdH , 61352, Germany
Bad Nauheim , 61231, Germany
Berlin , 10707, Germany
Berlin , 10967, Germany
Bonn , 53111, Germany
Bottrop , 46236, Germany
Dessau-Roßlau , 06847, Germany
Düsseldorf , 40235, Germany
Erfurt , 99084, Germany
Erlangen , 91054, Germany
Essen , 45136, Germany
Frankfurt , 60431, Germany
Frankfurt , 60596, Germany
Freiburg , 79110, Germany
Hamm , 59073, Germany
Hannover , 30559, Germany
Karlsruhe , 76133, Germany
Kiel , 24105, Germany
Leipzig , 04103, Germany
Lüneburg , 21339, Germany
München , 80336, Germany
Offenbach , 63069, Germany
Potsdam , 14467, Germany
Reutlingen , 72764, Germany
Schweinfurt , 97422, Germany
Stendal , 39576, Germany
Cholargos , 155 6, Greece
Crete , 711 1, Greece
Larissa , 411 1, Greece
Piraeus , 185 4, Greece
Thessaloniki , 546 4, Greece
Hong Kong , 852, Hong Kong
Hong Kong , , Hong Kong
Hong Kong , , Hong Kong
Budapest , 1032, Hungary
Budapest , 1062, Hungary
Budapest , 1122, Hungary
Debrecen , 4032, Hungary
Miskolc , 3501, Hungary
New Delhi Delhi, 11008, India
North WEST Delhi Delhi, 11008, India
Ahmadabad Gujarat, 38005, India
Bangalore Karnataka, 56001, India
Mumbai Maharashtra, 40001, India
Nashik Maharashtra, 42200, India
Pune Maharashtra, 41102, India
Wallajah Tamil NADU, 63251, India
Kolkata WEST Bengal, 70015, India
Avellino Campania, 83100, Italy
Napoli Campania, 80131, Italy
Napoli Campania, 80131, Italy
Bologna Emilia-Romagna, 40138, Italy
Modena Emilia-Romagna, 41100, Italy
Aviano Friuli-Venezia Giulia, 33081, Italy
Udine Friuli-Venezia Giulia, 33100, Italy
Roma Lazio, 00168, Italy
Brescia Lombardia, 25123, Italy
Milano Lombardia, 20132, Italy
Milano Lombardia, 20133, Italy
Livorno Toscana, 57124, Italy
Pisa Toscana, 56100, Italy
Novara Umbria, 28100, Italy
Padova Veneto, 35128, Italy
Eldoret , 30100, Kenya
Nairobi , 30270, Kenya
Daegu , 41404, Korea, Republic of
Goyang-si , 10408, Korea, Republic of
Seongnam-si , 13605, Korea, Republic of
Seoul , 02841, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06273, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Seoul , 08308, Korea, Republic of
La Paz BAJA California SUR, 23040, Mexico
Cdmx Mexico CITY (federal District), 03100, Mexico
Cdmx Mexico CITY (federal District), 06760, Mexico
Monterrey Nuevo LEON, 64570, Mexico
Oaxaca de Juárez Oaxaca, 68020, Mexico
Distrito Federal , 14000, Mexico
Auckland , 1023, New Zealand
Tauranga , 3112, New Zealand
Bialystok , 15-02, Poland
Gdańsk , 80-21, Poland
Gliwice , 44-10, Poland
Kraków , 30-68, Poland
Poznan , 61-86, Poland
Warszawa , 02-78, Poland
Lisboa , 1350-, Portugal
Lisboa , 1649-, Portugal
Loures , 2674-, Portugal
Porto , 4099-, Portugal
Porto , 4200-, Portugal
Bucuresti , 02116, Romania
Bucuresti , 02232, Romania
Cluj County , 40728, Romania
Cluj-Napoca , 40000, Romania
Cluj-Napoca , 40001, Romania
Craiova , 20034, Romania
Timisoara , 30023, Romania
Kazan Karelija, 42002, Russian Federation
St Petersburg Leningrad, 19775, Russian Federation
Moscow Moskovskaja Oblast, 14342, Russian Federation
Moskva Moskovskaja Oblast, 11112, Russian Federation
Nizhny Novgorod Niznij Novgorod, 60312, Russian Federation
Sankt-peterburg Sankt Petersburg, 19600, Russian Federation
Kaluga , 24800, Russian Federation
Krasnoyarsk , 66013, Russian Federation
Moscow , 10500, Russian Federation
Moscow , 11547, Russian Federation
Novosibirsk , 63009, Russian Federation
Saint-Petersburg , 19775, Russian Federation
Samara , 44303, Russian Federation
St Petersburg , 19110, Russian Federation
Tomsk , 63406, Russian Federation
Yaroslavl , 15004, Russian Federation
Singapore , 16961, Singapore
Elche Alicante, 03203, Spain
Badalona Barcelona, 08916, Spain
Sabadell Barcelona, 8208, Spain
A Coruña LA Coruña, 15006, Spain
Santiago de Compostela LA Coruña, 15706, Spain
Pozuelo de Alarcon Madrid, 28223, Spain
Vigo Pontevedra, 36213, Spain
La Laguna Tenerife, 38320, Spain
Bilbao Vizcaya, 48013, Spain
Barcelona , 08003, Spain
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Granada , 18016, Spain
Jaen , 23007, Spain
Madrid , 28007, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28046, Spain
Malaga , 29010, Spain
Salamanca , 37007, Spain
Sevilla , 41009, Spain
Sevilla , 41013, Spain
Valencia , 46010, Spain
Valencia , 46017, Spain
Zaragoza , 50009, Spain
Taichung , 404, Taiwan
Tainan , 704, Taiwan
Taipei 100 , 100, Taiwan
Taipei , 00112, Taiwan
Taipei , 104, Taiwan
Bangkok , 10330, Thailand
Bangkok , 10400, Thailand
Khon Kaen , 40002, Thailand
Songkla , 90110, Thailand
Adana , 01120, Turkey
Ankara , 06100, Turkey
Ankara , 06490, Turkey
Ankara , 06520, Turkey
Antalya , 07100, Turkey
Bornova, İ̇zmi̇r , 35100, Turkey
Diyarbakir , 21280, Turkey
Edirne , 22030, Turkey
Istanbul , 34093, Turkey
Istanbul , 34098, Turkey
Izmir , 35360, Turkey
Kadiköy , 34722, Turkey
Malatya , 44280, Turkey
Üsküdar , 34662, Turkey
Uzhhorod Katerynoslav Governorate, 88000, Ukraine
Kharkiv Kharkiv Governorate, 61070, Ukraine
Sumy Kholm Governorate, 40005, Ukraine
Dnipro KIEV Governorate, 49100, Ukraine
Liutizh KIEV Governorate, 07352, Ukraine
Dnipropetrovsk , 49102, Ukraine
Kirovograd , 25011, Ukraine
Kyiv , 03115, Ukraine
Belfast , BT9 7, United Kingdom
Blackpool , FY3 8, United Kingdom
Bradford , BD9 6, United Kingdom
Brighton , BN2 5, United Kingdom
Cambridge , CB2 0, United Kingdom
Cardiff , CF14 , United Kingdom
Cheltenham , GL53 , United Kingdom
Cornwall , TR1 3, United Kingdom
East Kilbride , G75 8, United Kingdom
Inverness , IV2 3, United Kingdom
London , EC1A , United Kingdom
London , NW1 -, United Kingdom
London , NW3 2, United Kingdom
London , SW3 6, United Kingdom
Manchester , M20 4, United Kingdom
Nottingham , NG5 1, United Kingdom
Preston , PR2 9, United Kingdom
Rhyl , LL18 , United Kingdom
Surrey , SM2 5, United Kingdom
Walsall , WS2 9, United Kingdom
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