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Brief Title: Extension Study to Provide Adjuvant Treatment Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03
Official Title: A Double-blinded Extension Study to Provide Adjuvant Treatment With Single Agent Herceptin® or TX05 and Assess Continued Safety and Immunogenicity in Subjects With HER2-positive Early Breast Cancer Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03
Study ID: NCT04109391
Brief Summary: This is an extension study to provide adjuvant treatment with single agent Herceptin or TX05 and assess continued safety and immunogenicity in subjects with HER2-positive early breast cancer following neoadjuvant treatment and surgical resection in Protocol TX05-03.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Tanvex Investigational Site 1003E, Gomel, , Belarus
Tanvex Investigational Site 1006E, Grodno, , Belarus
Tanvex Investigational Site 1008E, Lesnoy, , Belarus
Tanvex Investigational Site 1002E, Minsk, , Belarus
Tanvex Investigational Site 1005E, Mogilev, , Belarus
Tanvex Investigational Site 1001E, Vitebsk, , Belarus
Tanvex Investigational Site 4001E, Temuco, , Chile
Tanvex Investigational Site 4002E, Vina del Mar, , Chile
Tanvex Investigational Site 5006E, Batumi, , Georgia
Tanvex Investigational Site 5002E, Batumi, , Georgia
Tanvex Investigational Site 5001E, Tbilisi, , Georgia
Tanvex Investigational Site 5005E, Tbilisi, , Georgia
Tanvex Investigational Site 5010E, Tbilisi, , Georgia
Tanvex Investigational Site 5008E, Tbilisi, , Georgia
Tanvex Investigational Site 6003E, Budapest, , Hungary
Tanvex Investigational Site 7031E, Nashik, Maharashtra, India
Tanvex Investigational Site 7033E, Ahmedabad, , India
Tanvex Investigational Site 7019E, Bangalore, , India
Tanvex Investigational Site 7022E, Belgaum, , India
Tanvex Investigational Site 7045E, Hyderabad, , India
Tanvex Investigational Site 7036E, Hyderabad, , India
Tanvex Investigational Site 7006E, Kolkata, , India
Tanvex Investigational Site 7001E, Nashik, , India
Tanvex Investigational Site 7015E, Pune, , India
Tanvex Investigational Site 7017E, Vijayawada, , India
Tanvex Investigational Site 2109E, Aguascalientes, , Mexico
Tanvex Investigational Site 2103E, Monterrey, , Mexico
Tanvex Investigational Site 2106E, Oaxaca, , Mexico
Tanvex Investigational Site 2110E, Tequisquiapan, , Mexico
Tanvex Investigational Site 2108E, Zapopan, , Mexico
Tanvex Investigational Site 1101E, Arequipa, , Peru
Tanvex Investigational Site 1107E, Arequipa, , Peru
Tanvex Investigational Site 1104E, Chiclayo, , Peru
Tanvex Investigational Site 1112E, Lima Cercado, , Peru
Tanvex Investigational Site 1105E, Lima, , Peru
Tanvex Investigational Site 1108E, San Borja, , Peru
Tanvex Investigational Site 1102E, San Isidro, , Peru
Tanvex Investigational Site 1109E, Surquillo, , Peru
Tanvex Investigational Site 1103E, Trujillo, , Peru
Tanvex Investigational Site 1211E, Cebu city, , Philippines
Tanvex Investigational Site 1212E, Davao City, , Philippines
Tanvex Investigational Site 1214E, Makati City, , Philippines
Tanvex Investigational Site 1209E, Quezon City, , Philippines
Tanvex Investigational Site 1213E, Quezon City, , Philippines
Tanvex Invesitgational Site 1210E, Santo Tomas, , Philippines
Tanvex Investigational Site 1513E, Sochi, Krasnodar Region, Russian Federation
Tanvex Investigational Site 1535E, Arkhangelsk, , Russian Federation
Tanvex Investigational Site 1531E, Belgorod, , Russian Federation
Tanvex Investigational Site 1502E, Kaluga, , Russian Federation
Tanvex Investigational Site 1505E, Kislino, , Russian Federation
Tanvex Investigational Site 1529E, Krasnodar, , Russian Federation
Tanvex Investigational Site 1512E, Krasnoyarsk, , Russian Federation
Tanvex Investigational Site 1530E, Moscow, , Russian Federation
Tanvex Investigational Site 1507E, Moscow, , Russian Federation
Tanvex Investigational Site 1511E, Novosibirsk, , Russian Federation
Tanvex Investigational Site 1503E, Omsk, , Russian Federation
Tanvex Investigational Site 1509E, Omsk, , Russian Federation
Tanvex Investigational Site 1537E, Orenburg, , Russian Federation
Tanvex Investigational Site 1526E, Pesochnyy, , Russian Federation
Tanvex Investigational Site 1510E, Pushkin, , Russian Federation
Tanvex Investigational Site 1521E, Rostov-Na-Donu, , Russian Federation
Tanvex Investigational Site 1516E, Saint Petersburg, , Russian Federation
Tanvex Investigational Site 1524E, Saint Petersburg, , Russian Federation
Tanvex Investigational Site 1525E, Saint Petersburg, , Russian Federation
Tanvex Investigational Site 1506E, Saint Petersburg, , Russian Federation
Tanvex Investigational Site 1501E, Saint Petersburg, , Russian Federation
Tanvex Investigational Site 1523E, Sankt-peterburg, , Russian Federation
Tanvex Investigational Site 1508E, Saransk, , Russian Federation
Tanvex Investigational Site 1534E, Yaroslavl, , Russian Federation
Tanvex Investigational Site 1820E, Antonivka, , Ukraine
Tanvex Investigational Site 1803E, Chernihiv, , Ukraine
Tanvex Investigational Site 1808E, Chernihiv, , Ukraine
Tanvex Investigational Site 1821E, Chernivtsi, , Ukraine
Tanvex Investigational Site 1824E, Dnipro, , Ukraine
Tanvex Investigational Site 1811E, Kiev, , Ukraine
Tanvex Investigational Site 1802E, Kiev, , Ukraine
Tanvex Investigational Site 1819E, Kropyvnytskyi, , Ukraine
Tanvex Investigational Site 1814E, Kropyvnytskyi, , Ukraine
Tanvex Investigational Site 1804E, Kryvyi Rih, , Ukraine
Tanvex Investigational Site 1815E, Kyiv, , Ukraine
Tanvex Investigational Site 1809E, Kyiv, , Ukraine
Tanvex Investigational Site 1810E, Odesa, , Ukraine
Tanvex Investigational Site 1806E, Sumy, , Ukraine
Tanvex Investigational Site 1822E, Ternopil, , Ukraine
Tanvex Investigational Site 1818E, Vinnytsia, , Ukraine
Tanvex Investigational Site 1813E, Zaporizhzhya, , Ukraine
Name: Bonnie Mills, PhD
Affiliation: Tanvex BioPharma USA, Inc.
Role: STUDY_DIRECTOR