Extension Study to Provide Adjuvant Treatment Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03

PHASE3CompletedINTERVENTIONAL
Enrollment

338

Participants

Timeline

Start Date

August 20, 2019

Primary Completion Date

December 25, 2021

Study Completion Date

March 8, 2022

Conditions
HER2-positive Breast CancerEarly-stage Breast CancerBreast CancerBreast NeoplasmsStage II Breast CancerStage IIIA Breast Cancer
Interventions
BIOLOGICAL

TX05 (trastuzumab)

Subjects will receive up to 13 cycles of adjuvant treatment.

BIOLOGICAL

Herceptin (trastuzumab)

Subjects will receive up to 13 cycles of adjuvant treatment.

Trial Locations (86)

41

Tanvex Investigational Site 1108E, San Borja

112

Tanvex Investigational Site 5008E, Tbilisi

1101

Tanvex Investigational Site 1209E, Quezon City

1102

Tanvex Investigational Site 1213E, Quezon City

1229

Tanvex Investigational Site 1214E, Makati City

4234

Tanvex Invesitgational Site 1210E, Santo Tomas

6000

Tanvex Investigational Site 5006E, Batumi

Tanvex Investigational Site 1211E, Cebu City

6010

Tanvex Investigational Site 5002E, Batumi

8000

Tanvex Investigational Site 1212E, Davao City

13001

Tanvex Investigational Site 1103E, Trujillo

14001

Tanvex Investigational Site 1104E, Chiclayo

14029

Tanvex Investigational Site 1803E, Chernihiv

Tanvex Investigational Site 1808E, Chernihiv

15036

Tanvex Investigational Site 1105E, Lima

15038

Tanvex Investigational Site 1109E, Surquillo

15073

Tanvex Investigational Site 1102E, San Isidro

15082

Tanvex Investigational Site 1112E, Lima Cercado

20234

Tanvex Investigational Site 2109E, Aguascalientes

21029

Tanvex Investigational Site 1818E, Vinnytsia

25006

Tanvex Investigational Site 1819E, Kropyvnytskyi

25011

Tanvex Investigational Site 1814E, Kropyvnytskyi

40022

Tanvex Investigational Site 1806E, Sumy

45030

Tanvex Investigational Site 2108E, Zapopan

46023

Tanvex Investigational Site 1822E, Ternopil

49600

Tanvex Investigational Site 1824E, Dnipro

50048

Tanvex Investigational Site 1804E, Kryvyi Rih

58013

Tanvex Investigational Site 1821E, Chernivtsi

64000

Tanvex Investigational Site 2103E, Monterrey

65055

Tanvex Investigational Site 1810E, Odesa

68000

Tanvex Investigational Site 2106E, Oaxaca City

69059

Tanvex Investigational Site 1813E, Zaporizhzhya

73000

Tanvex Investigational Site 1820E, Antonivka

76750

Tanvex Investigational Site 2110E, Tequisquiapan

121467

Tanvex Investigational Site 1530E, Moscow

150054

Tanvex Investigational Site 1534E, Yaroslavl

163045

Tanvex Investigational Site 1535E, Arkhangelsk

191015

Tanvex Investigational Site 1516E, Saint Petersburg

191104

Tanvex Investigational Site 1523E, Saint Petersburg

Tanvex Investigational Site 1524E, Saint Petersburg

196247

Tanvex Investigational Site 1525E, Saint Petersburg

196603

Tanvex Investigational Site 1510E, Pushkin

197758

Tanvex Investigational Site 1526E, Pesochnyy

Tanvex Investigational Site 1506E, Saint Petersburg

210603

Tanvex Investigational Site 1001E, Vitebsk

212018

Tanvex Investigational Site 1005E, Mogilev

220013

Tanvex Investigational Site 1002E, Minsk

223040

Tanvex Investigational Site 1008E, Lesnoy

230017

Tanvex Investigational Site 1006E, Grodno

246012

Tanvex Investigational Site 1003E, Homyel

305524

Tanvex Investigational Site 1505E, Kislino

308010

Tanvex Investigational Site 1531E, Belgorod

344037

Tanvex Investigational Site 1521E, Rostov-on-Don

350040

Tanvex Investigational Site 1529E, Krasnodar

354057

Tanvex Investigational Site 1513E, Sochi

380016

Tanvex Investigational Site 7033E, Ahmedabad

411001

Tanvex Investigational Site 7015E, Pune

422002

Tanvex Investigational Site 7031E, Nashik

Tanvex Investigational Site 7001E, Nashik

430032

Tanvex Investigational Site 1508E, Saransk

460021

Tanvex Investigational Site 1537E, Orenburg

500004

Tanvex Investigational Site 7045E, Hyderabad

500034

Tanvex Investigational Site 7036E, Hyderabad

520002

Tanvex Investigational Site 7017E, Vijayawada

560027

Tanvex Investigational Site 7019E, Bangalore

590010

Tanvex Investigational Site 7022E, Belagavi

630099

Tanvex Investigational Site 1511E, Novosibirsk

644013

Tanvex Investigational Site 1503E, Omsk

Tanvex Investigational Site 1509E, Omsk

660133

Tanvex Investigational Site 1512E, Krasnoyarsk

700099

Tanvex Investigational Site 7006E, Kolkata

2520598

Tanvex Investigational Site 4001E, Temuco

4810469

Tanvex Investigational Site 4002E, Viña del Mar

0159

Tanvex Investigational Site 5001E, Tbilisi

Tanvex Investigational Site 5005E, Tbilisi

0186

Tanvex Investigational Site 5010E, Tbilisi

Unknown

Tanvex Investigational Site 6003E, Budapest

Tanvex Investigational Site 1502E, Kaluga

Tanvex Investigational Site 1507E, Moscow

Tanvex Investigational Site 1501E, Saint Petersburg

04001

Tanvex Investigational Site 1101E, Arequipa

Tanvex Investigational Site 1107E, Arequipa

03115

Tanvex Investigational Site 1811E, Kiev

04107

Tanvex Investigational Site 1802E, Kiev

03022

Tanvex Investigational Site 1815E, Kyiv

03126

Tanvex Investigational Site 1809E, Kyiv

All Listed Sponsors
lead

Tanvex BioPharma USA, Inc.

INDUSTRY

NCT04109391 - Extension Study to Provide Adjuvant Treatment Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03 | Biotech Hunter | Biotech Hunter