Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

809

Participants

Timeline

Start Date

June 28, 2018

Primary Completion Date

November 27, 2020

Study Completion Date

February 4, 2021

Conditions
Breast CancerBreast NeoplasmsHER2-positive Breast CancerStage II Breast CancerStage IIIA Breast Cancer
Interventions
BIOLOGICAL

TX05 (trastuzumab)

8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)

BIOLOGICAL

Herceptin®

8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)

DRUG

Paclitaxel

175 mg/m\^2, 60 min IV infusion, every 3 weeks (Cycles 5-8)

DRUG

Epirubicin

75 mg/m\^2, IV bolus infusion, every 3 weeks (Cycles 1-4)

DRUG

Cyclophosphamide

600 mg/m\^2, 30 min IV infusion, every 3 weeks (Cycles 1-4)

Trial Locations (146)

112

Tanvex Investigational Site 5008, Tbilisi

131

Tanvex Investigational Site 5009, Tbilisi

141

Tanvex Investigational Site 5007, Tbilisi

1000

Tanvex Investigational Site 1207, Manila

Tanvex Investigational Site 1201, Manila

1101

Tanvex Investigational Site 1209, Quezon City

1102

Tanvex Investigational Site 1213, Quezon City

1110

Tanvex Investigational Site 1208, Quezon City

1122

Tanvex Investigational Site 6003, Budapest

Tanvex Investigational Site 6007, Budapest

1229

Tanvex Investigational Site 1214, Makati City

3526

Tanvex Investigational Site 6004, Miskolc

4032

Tanvex Investigational Site 6005, Debrecen

4234

Tanvex Investigational Site 1210, Santo Tomas

6000

Tanvex Investigational Site 5006, Batumi

Tanvex Investigational Site 1203, Cebu City

Tanvex Investigational Site 1204, Cebu City

Tanvex Investigational Site 1211, Cebu City

6010

Tanvex Investigational Site 5002, Batumi

6100

Tanvex Investigational Site 1206, Bacolod City

7264

Tanvex Investigational Site 6001, Pécs

8000

Tanvex Investigational Site 1212, Davao City

9024

Tanvex Investigational Site 6006, Győr

13001

Tanvex Investigational Site 1103, Trujillo

14001

Tanvex Investigational Site 1104, Chiclayo

14029

Tanvex Investigational Site 1808, Chernihiv

15036

Tanvex Investigational Site 1108, San Borja

Tanvex Investigational Site 1113, San Borja

Tanvex Investigational Site 1105, San Isidro

15038

Tanvex Investigational Site 1109, Surquillo

15046

Tanvex Investigational Site 1110, Lima

15073

Tanvex Investigational Site 1102, San Isidro

15082

Tanvex Investigational Site 1112, Lima Cercado

20127

Tanvex Investigational Site 2117, Aguascalientes

20234

Tanvex Investigational Site 2109, Aguascalientes

21008

Tanvex Investigational Site 1001, Vitebsk

21029

Tanvex Investigational Site 1818, Vinnitsya

25000

Tanvex Investigational Site 1814, Kropyvnytskyi

25006

Tanvex Investigational Site 1819, Kropyvnytskyi

29000

Tanvex Investigational Site 1812, Khmelnytskyi

40022

Tanvex Investigational Site 1806, Sumy

45030

Tanvex Investigational Site 2108, Zapopan

46023

Tanvex Investigational Site 1822, Ternopil

49102

Tanvex Investigational Site 1803, Dnipro

49600

Tanvex Investigational Site 1824, Dnipro

50048

Tanvex Investigational Site 1804, Kryvyi Rih

54769

Tanvex Investigational Site 2101, Cuautitlán Izcalli

58013

Tanvex Investigational Site 1821, Chernivtsi

64000

Tanvex Investigational Site 2102, Monterrey

64320

Tanvex Investigational Site 2103, Monterrey

65055

Tanvex Investigational Site 1810, Odesa

68000

Tanvex Investigational Site 2106, Oaxaca City

69104

Tanvex Investigational Site 1813, Zaporizhzhia

73000

Tanvex Investigational Site 1820, Kherson

76750

Tanvex Investigational Site 2110, Tequisquiapan

77506

Tanvex Investigational Site 2116, Cancún

78200

Tanvex Investigational Site 2112, San Luis Potosí City

88000

Tanvex Investigational Site 1823, Uzhhorod

121467

Tanvex Investigational Site 1530, Moscow

122001

Tanvex Investigational Site 7024, Gūrgaon

125284

Tanvex Investigational Site 1536, Moscow

129128

Tanvex Investigational Site 1514, Moscow

129515

Tanvex Investigational Site 1507, Moscow

141002

Tanvex Investigational Site 7041, Model Town

150054

Tanvex Investigational Site 1534, Yaroslavl

153040

Tanvex Investigational Site 1520, Ivanovo

160012

Tanvex Investigational Site 7034, Chandigarh

163045

Tanvex Investigational Site 1535, Arkhangelsk

191015

Tanvex Investigational Site 1516, Saint Petersburg

191025

Tanvex Investigational Site 1517, Saint Petersburg

191104

Tanvex Investigational Site 1523, Saint Petersburg

195271

Tanvex Investigational Site 1524, Saint Petersburg

196247

Tanvex Investigational Site 1525, Saint Petersburg

196603

Tanvex Investigational Site 1510, Pushkin

197758

Tanvex Investigational Site 1506, Saint Petersburg

Tanvex Investigational Site 1526, Saint Petersburg

198255

Tanvex Investigational Site 1501, Saint Petersburg

213825

Tanvex Investigational Site 1007, Babruysk

220013

Tanvex Investigational Site 1002, Minsk

223040

Tanvex Investigational Site 1008, Lyasny

226003

Tanvex Investigational Site 7005, Lucknow

230017

Tanvex Investigational Site 1006, Grodno

246012

Tanvex Investigational Site 1003, Homyel

248007

Tanvex Investigational Site 1502, Kaluga

302004

Tanvex Investigational Site 7009, Jaipur

305035

Tanvex Investigational Site 1505, Kursk

308010

Tanvex Investigational Site 1531, Belgorod

334003

Tanvex Investigational Site 7002, Bikaner

344037

Tanvex Investigational Site 1521, Rostov-on-Don

350040

Tanvex Investigational Site 1529, Krasnodar

354057

Tanvex Investigational Site 1513, Sochi

357502

Tanvex Investigational Site 1519, Pyatigorsk

380016

Tanvex Invesitgational Site 7033, Ahmedabad

390007

Tanvex Investigational Site 7018, Vadodara

411001

Tanvex Investigational Site 7015, Pune

411004

Tanvex Investigational Site 7003, Pune

Tanvex Investigational Site 7004, Pune

420029

Tanvex Investigational Site 1540, Kazan'

422002

Tanvex Investigational Site 7001, Nashik

422004

Tanvex Investigational Site 7031, Nāka

422005

Tanvex Investigational Site 7007, Nashik

426009

Tanvex Investigational Site 1515, Izhevsk

430032

Tanvex Investigational Site 1508, Saransk

450054

Tanvex Investigational Site 1522, Ufa

454048

Tanvex Investigational Site 1538, Chelyabinsk

460021

Tanvex Investigational Site 1537, Orenburg

500004

Tanvex Investigational Site 7045, Hyderabad

500034

Tanvex Investigational Site 7036, Hyderabad

520002

Tanvex Investigational Site 7017, Vijayawada

560027

Tanvex Investigational Site 7019, Bangalore

560072

Tanvex Investigational Site 7037, Bangalore

576104

Tanvex Investigational Site 7012, Manipal

590010

Tanvex Investigational Site 7022, Belagavi

620008

Tanvex Investigational Site 7042, Trichy

625107

Tanvex Investigational Site 7010, Madurai

630099

Tanvex Investigational Site 1511, Novosibirsk

634009

Tanvex Investigational Site 1533, Tomsk

634050

Tanvex Investigational Site 1518, Tomsk

641037

Tanvex Investigational Site 7013, Coimbatore

644013

Tanvex Investigational Site 1509, Omsk

Tanvex Investigational Site 1503, Omsk

660133

Tanvex Investigational Site 1512, Krasnoyarsk

700014

Tanvex Investigational Site 7039, Kolkata

700094

Tanvex Investigational Site 7040, Kolkata

700099

Tanvex Investigational Site 7006, Kolkata

2120018

Tanvex Investigational Site 1005, Mogilev

2520598

Tanvex Investigational Site 4002, Viña del Mar

4810469

Tanvex Investigational Site 4001, Temuco

0144

Tanvex Investigational Site 5003, Tbilisi

0159

Tanvex Investigational Site 5001, Tbilisi

Tanvex Investigational Site 5005, Tbilisi

Tanvex Investigational Site 5012, Tbilisi

0177

Tanvex Investigational Site 5013, Tbilisi

0179

Tanvex Investigational Site 5004, Tbilisi

0186

Tanvex Investigational Site 5010, Tbilisi

Tanvex Investigational Site 5011, Tbilisi

06100

Tanvex Investigational Site 2104, Cuauhtémoc

Tanvex Investigational Site 2113, México

06760

Tanvex Investigational Site 2114, Cuauhtémoc

Tanvex Investigational Site 2111, Mexico City

04001

Tanvex Investigational Site 1101, Arequipa

Tanvex Investigational Site 1107, Arequipa

03022

Tanvex Investigational Site 1815, Kiev

03115

Tanvex Investigational Site 1811, Kiev

04107

Tanvex Investigational Site 1802, Kiev

03126

Tanvex Investigational Site 1809, Kyiv

All Listed Sponsors
lead

Tanvex BioPharma USA, Inc.

INDUSTRY

NCT03556358 - Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer | Biotech Hunter | Biotech Hunter