Breast Cancer Clinical Trial
A Study of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo as a Treatment for Participants With Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC)
Summary
This study will evaluate the efficacy, safety and patient-reported outcomes of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo in participants with HER2-positive and PD-L1-positive LABC or MBC.Participants must have progressed either during or after prior trastuzumab- (+/- pertuzumab) and taxane-based therapy for LABC/MBC; or during (or within 6 months after completing) trastuzumab- (+/-pertuzumab) and taxane-based therapy in the neoadjuvant and/or adjuvant setting.
Eligibility Criteria
Inclusion Criteria:
HER2+ and PD-L1+ locally advanced (LABC) or metastatic breast cancer (MBC)
Progression must have occurred during most recent treatment for LABC/MBC or during, or within 6 months after completing, neoadjuvant and/or adjuvant therapy
Prior treatment with trastuzumab (+/- pertuzumab) and taxane in the neoadjuvant and/or adjuvant, locally advanced, or metastatic setting
No more than two prior lines of therapy in the metastatic setting
Measurable disease per RESIST version 1.1
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Life expectancy >= 6 months
Adequate hematologic and end-organ function
For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs
For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm
Exclusion Criteria:
Prior treatment with trastuzumab emtansine in metastatic setting
History of exposure to cumulative doses of anthracyclines
Symptomatic or actively progressing central nervous system (CNS) metastases; asymptomatic CNS lesions ≤ 2cm without clinical requirement for local intervention or asymptomatic patients with treated CNS lesions are eligible
Current Grade >= 3 peripheral neuropathy
Cardiopulmonary dysfunction
History of malignancy within 5 years prior to initiation of study treatment, with the exception of the cancer under investigation and malignancies with a negligible risk of metastasis or death
History of leptomeningeal disease
Active or history of autoimmune disease or immune deficiency
Active hepatitis B, hepatitis C and/or tuberculosis
Prior allogeneic stem cell or solid organ transplantation
Receipt of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, during treatment, or within 5 months following the last dose of study treatment
Pregnancy or lactation
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There are 137 Locations for this study
Fountain Valley California, 92708, United States
Redlands California, 92373, United States
Marietta Georgia, 30060, United States
Saint Louis Missouri, 63141, United States
Farmington New Mexico, 87401, United States
Westbury New York, 11590, United States
Pittsburgh Pennsylvania, 15213, United States
Gateshead New South Wales, 2290, Australia
St. Leonards New South Wales, 2065, Australia
Woolloongabba Queensland, 4102, Australia
North Melbourne Victoria, 3051, Australia
St Albans Victoria, 3021, Australia
Salvador BA, 41253, Brazil
Goiania GO, 74605, Brazil
Recife PE, 50040, Brazil
Ijui RS, 98700, Brazil
Porto Alegre RS, 91350, Brazil
Sao Jose do Rio Preto SP, 15090, Brazil
Sao Paulo SP, 01317, Brazil
Sao Paulo SP, 04014, Brazil
Barrie Ontario, L4M 6, Canada
Oshawa Ontario, L1G 2, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M4N 3, Canada
Montreal Quebec, H2X 0, Canada
Montreal Quebec, H4A 3, Canada
Montréal Quebec, H3T 1, Canada
Sherbrooke Quebec, J1H 5, Canada
Beijing , 10004, China
Beijing , 10014, China
Changchun City , 13002, China
Changsha City , 41001, China
Guangzhou City , 51012, China
Hangzhou , 31000, China
Hangzhou , 31001, China
Harbin , 15008, China
Kunming City , 65010, China
Nanjing City , 21002, China
Shenzhen , 51803, China
Tianjing , 30006, China
Wuhan City , 43002, China
Xian , 71006, China
Zhejiang , 31002, China
Zhengzhou , 45000, China
Medellin , , Colombia
Monteria , 23000, Colombia
Pereira , 60000, Colombia
Split , 21000, Croatia
Zagreb , 10000, Croatia
Zagreb , 10000, Croatia
Helsinki , 00250, Finland
Oulu , 90029, Finland
Tampere , 33520, Finland
Amiens , 80054, France
Bordeaux , 33300, France
Grenoble , 38043, France
Lille , 59020, France
Nice , 06189, France
Paris , 75020, France
Poitiers , 86021, France
Saint-Cloud , 92211, France
Toulouse , 31059, France
Vandoeuvre-les-nancy , 54519, France
Dresden , 01127, Germany
Hannover , 30559, Germany
Heidelberg , 69120, Germany
Köln , 50935, Germany
Athens , 115 2, Greece
Athens , 115 2, Greece
Heraklion, Crete , 711 1, Greece
Thessaloniki , 546 4, Greece
Budapest , 1032, Hungary
Budapest , 1122, Hungary
Debrecen , 4032, Hungary
Miskolc , 3501, Hungary
Avellino Campania, 83100, Italy
Napoli Campania, 80131, Italy
Napoli Campania, 80131, Italy
Bologna Emilia-Romagna, 40138, Italy
Reggio Emilia Emilia-Romagna, 42123, Italy
Genova Liguria, 16132, Italy
Bergamo Lombardia, 24100, Italy
Milano Lombardia, 20132, Italy
Milano Lombardia, 20141, Italy
Rozzano Lombardia, 20089, Italy
Pisa Toscana, 56100, Italy
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 08308, Korea, Republic of
Bergen , 5021, Norway
Grålum , 1714, Norway
Oslo , 0450, Norway
Stavanger , 4011, Norway
Cebu City , 6000, Philippines
Quezon City , 1102, Philippines
San Juan , 1502, Philippines
Gdansk , 80-21, Poland
Konin , 62-50, Poland
Koszalin , 75-58, Poland
Kraków , 30-68, Poland
Lodz , 90-24, Poland
Opole , 45-06, Poland
Poznan , 60-56, Poland
Warszawa , 02-78, Poland
Wieliszew , 05-13, Poland
Lisboa , 1099-, Portugal
Lisboa , 1400-, Portugal
Lisboa , 1649-, Portugal
Porto , 4099-, Portugal
Porto , 4200-, Portugal
Moscow , 11547, Russian Federation
Saint-Petersburg , 19825, Russian Federation
Samara , 44303, Russian Federation
Saratov , 41005, Russian Federation
ST Petersburg , 19775, Russian Federation
Ufa , 45005, Russian Federation
Ljubljana , 1000, Slovenia
Castellon de La Plana Castellon, 12002, Spain
Pozuelo de Alarcón Madrid, 28223, Spain
Vigo Pontevedra, 36312, Spain
Barcelona , 08035, Spain
Madrid , 28046, Spain
Malaga , 29010, Spain
Malaga , 29011, Spain
Sevilla , 41013, Spain
Adana , 01220, Turkey
Adapazari/Sakarya , 54100, Turkey
Ankara , 06520, Turkey
Bakirkoy / Istanbul , 34147, Turkey
Istanbul , 34742, Turkey
Izmir , 35360, Turkey
Kayseri , 38000, Turkey
Malatya , 44280, Turkey
Sihhiye/Ankara , 06230, Turkey
Leicester , LE1 5, United Kingdom
London , NW1 2, United Kingdom
London , SE1 9, United Kingdom
Manchester , M20 4, United Kingdom
Milton Keynes , MK6 5, United Kingdom
Nottingham , NG5 1, United Kingdom
Peterborough , PE3 9, United Kingdom
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