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

NCT ID: NCT03556358

Last Updated: 2022-01-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

809 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-28

Study Completion Date

2021-02-04

Brief Summary

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This is a Phase III, double-blind, randomized, multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of TX05 (trastuzumab) with Herceptin® in subjects with HER2 positive early breast cancer.

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Detailed Description

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Conditions

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Breast Cancer Breast Neoplasms HER2-positive Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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TX05 (trastuzumab)

• Intravenous (IV) epirubicin, 75 mg/m\^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles

Followed by:

• IV TX05 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles

Group Type EXPERIMENTAL

TX05 (trastuzumab)

Intervention Type BIOLOGICAL

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

Paclitaxel

Intervention Type DRUG

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

Epirubicin

Intervention Type DRUG

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

Cyclophosphamide

Intervention Type DRUG

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

Herceptin®

• Intravenous (IV) epirubicin, 75 mg/m\^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles

Followed by:

• IV Herceptin 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles

Group Type ACTIVE_COMPARATOR

Herceptin®

Intervention Type BIOLOGICAL

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

Paclitaxel

Intervention Type DRUG

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

Epirubicin

Intervention Type DRUG

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

Cyclophosphamide

Intervention Type DRUG

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

Interventions

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TX05 (trastuzumab)

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

Intervention Type BIOLOGICAL

Herceptin®

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

Intervention Type BIOLOGICAL

Paclitaxel

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

Intervention Type DRUG

Epirubicin

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

Intervention Type DRUG

Cyclophosphamide

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

Intervention Type DRUG

Other Intervention Names

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Ribotax

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed HER 2 overexpressing invasive primary operable Stage II/IIIa breast cancer (AJCC version 7 staging criteria).
* Available tumor tissue for central review of HER2 status.
* Planned surgical resection of breast tumor.
* Planned neoadjuvant chemotherapy.
* Documentation of HER2 gene amplification or overexpression.
* Ipsilateral, measurable tumor longest diameter \> 2 cm.
* Known estrogen receptor (ER) and progesterone receptor (PR) hormone status (may be performed during screening).
* ECOG performance status of 0 or 1.
* Adequate bone marrow, hepatic and renal functions.
* Left ventricular ejection fraction (LVEF) ≥ 50% or within institutional normal limits, measured by echocardiography or MUGA scan.
* Effective contraception as defined by protocol.

Exclusion Criteria

* Investigational therapy within 2 months of first dose of study drug.
* Bilateral breast cancer.
* Inflammatory breast cancer
* Metastases.
* Prior chemotherapy, biologic therapy, radiation or surgery for any active malignancy, including breast cancer.
* Cardiac insufficiency, myocardial infarction, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident, unstable angina pectoris, uncontrolled arrhythmia or pulmonary embolus within the previous 12 months prior to 1st administration of study drug.
* Clinically significant active infection, poorly controlled diabetes mellitus and/or uncontrolled hypertension.
* Major surgery, significant traumatic injury, radiation therapy and/or grade 3 hemorrhage within 4 weeks of 1st administration of study drug.
* Pre-existing clinically significant Grade 2 peripheral neuropathy.
* Malignancy within the last 5 years (except squamous/basal cell carcinoma of the skin, cervical carcinoma in situ and superficial bladder cancer).
* Severe dyspnea at rest requiring oxygen therapy.
* Known positive HIV, acute or chronic active infection with Hepatitis B or Hepatitis C.
* Current pregnancy or breastfeeding.
* Pre-existing thyroid abnormality with thyroid function that cannot be maintained in normal range despite optimal therapy.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tanvex BioPharma USA, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bonnie Mills, PhD

Role: STUDY_DIRECTOR

Tanvex BioPharma USA, Inc.

Locations

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Tanvex Investigational Site 1008

Lyasny, Minsk Oblast, Belarus

Site Status

Tanvex Investigational Site 1007

Babruysk, Mogilyov Oblast, Belarus

Site Status

Tanvex Investigational Site 1006

Grodno, , Belarus

Site Status

Tanvex Investigational Site 1003

Homyel, , Belarus

Site Status

Tanvex Investigational Site 1002

Minsk, , Belarus

Site Status

Tanvex Investigational Site 1005

Mogilev, , Belarus

Site Status

Tanvex Investigational Site 1001

Vitebsk, , Belarus

Site Status

Tanvex Investigational Site 4001

Temuco, , Chile

Site Status

Tanvex Investigational Site 4002

Viña del Mar, , Chile

Site Status

Tanvex Investigational Site 5006

Batumi, , Georgia

Site Status

Tanvex Investigational Site 5002

Batumi, , Georgia

Site Status

Tanvex Investigational Site 5003

Tbilisi, , Georgia

Site Status

Tanvex Investigational Site 5001

Tbilisi, , Georgia

Site Status

Tanvex Investigational Site 5005

Tbilisi, , Georgia

Site Status

Tanvex Investigational Site 5012

Tbilisi, , Georgia

Site Status

Tanvex Investigational Site 5013

Tbilisi, , Georgia

Site Status

Tanvex Investigational Site 5004

Tbilisi, , Georgia

Site Status

Tanvex Investigational Site 5010

Tbilisi, , Georgia

Site Status

Tanvex Investigational Site 5011

Tbilisi, , Georgia

Site Status

Tanvex Investigational Site 5008

Tbilisi, , Georgia

Site Status

Tanvex Investigational Site 5009

Tbilisi, , Georgia

Site Status

Tanvex Investigational Site 5007

Tbilisi, , Georgia

Site Status

Tanvex Investigational Site 6003

Budapest, , Hungary

Site Status

Tanvex Investigational Site 6007

Budapest, , Hungary

Site Status

Tanvex Investigational Site 6005

Debrecen, , Hungary

Site Status

Tanvex Investigational Site 6006

Győr, , Hungary

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Tanvex Investigational Site 6004

Miskolc, , Hungary

Site Status

Tanvex Investigational Site 6001

Pécs, , Hungary

Site Status

Tanvex Investigational Site 7007

Nashik, Maharashtra, India

Site Status

Tanvex Investigational Site 7015

Pune, Maharashtra, India

Site Status

Tanvex Investigational Site 7003

Pune, Maharashtra, India

Site Status

Tanvex Investigational Site 7004

Pune, Maharashtra, India

Site Status

Tanvex Investigational Site 7002

Bikaner, Rajasthan, India

Site Status

Tanvex Investigational Site 7010

Madurai, Tamil Nadu, India

Site Status

Tanvex Invesitgational Site 7033

Ahmedabad, , India

Site Status

Tanvex Investigational Site 7019

Bangalore, , India

Site Status

Tanvex Investigational Site 7037

Bangalore, , India

Site Status

Tanvex Investigational Site 7022

Belagavi, , India

Site Status

Tanvex Investigational Site 7034

Chandigarh, , India

Site Status

Tanvex Investigational Site 7013

Coimbatore, , India

Site Status

Tanvex Investigational Site 7024

Gurgaon, , India

Site Status

Tanvex Investigational Site 7045

Hyderabad, , India

Site Status

Tanvex Investigational Site 7036

Hyderabad, , India

Site Status

Tanvex Investigational Site 7009

Jaipur, , India

Site Status

Tanvex Investigational Site 7039

Kolkata, , India

Site Status

Tanvex Investigational Site 7040

Kolkata, , India

Site Status

Tanvex Investigational Site 7006

Kolkata, , India

Site Status

Tanvex Investigational Site 7005

Lucknow, , India

Site Status

Tanvex Investigational Site 7012

Manipal, , India

Site Status

Tanvex Investigational Site 7041

Model Town, , India

Site Status

Tanvex Investigational Site 7001

Nashik, , India

Site Status

Tanvex Investigational Site 7031

Nāka, , India

Site Status

Tanvex Investigational Site 7042

Trichy, , India

Site Status

Tanvex Investigational Site 7018

Vadodara, , India

Site Status

Tanvex Investigational Site 7017

Vijayawada, , India

Site Status

Tanvex Investigational Site 2102

Monterrey, Nuevo León, Mexico

Site Status

Tanvex Investigational Site 2117

Aguascalientes, , Mexico

Site Status

Tanvex Investigational Site 2109

Aguascalientes, , Mexico

Site Status

Tanvex Investigational Site 2116

Cancún, , Mexico

Site Status

Tanvex Investigational Site 2104

Cuauhtémoc, , Mexico

Site Status

Tanvex Investigational Site 2114

Cuauhtémoc, , Mexico

Site Status

Tanvex Investigational Site 2101

Cuautitlán Izcalli, , Mexico

Site Status

Tanvex Investigational Site 2111

Mexico City, , Mexico

Site Status

Tanvex Investigational Site 2113

México, , Mexico

Site Status

Tanvex Investigational Site 2103

Monterrey, , Mexico

Site Status

Tanvex Investigational Site 2106

Oaxaca City, , Mexico

Site Status

Tanvex Investigational Site 2112

San Luis Potosí City, , Mexico

Site Status

Tanvex Investigational Site 2110

Tequisquiapan, , Mexico

Site Status

Tanvex Investigational Site 2108

Zapopan, , Mexico

Site Status

Tanvex Investigational Site 1104

Chiclayo, Lambayeque, Peru

Site Status

Tanvex Investigational Site 1112

Lima Cercado, Lima region, Peru

Site Status

Tanvex Investigational Site 1108

San Borja, Lima region, Peru

Site Status

Tanvex Investigational Site 1113

San Borja, Lima region, Peru

Site Status

Tanvex Investigational Site 1101

Arequipa, , Peru

Site Status

Tanvex Investigational Site 1107

Arequipa, , Peru

Site Status

Tanvex Investigational Site 1110

Lima, , Peru

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Tanvex Investigational Site 1105

San Isidro, , Peru

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Tanvex Investigational Site 1102

San Isidro, , Peru

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Tanvex Investigational Site 1109

Surquillo, , Peru

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Tanvex Investigational Site 1103

Trujillo, , Peru

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Tanvex Investigational Site 1210

Santo Tomas, Batangas, Philippines

Site Status

Tanvex Investigational Site 1203

Cebu City, Cebu, Philippines

Site Status

Tanvex Investigational Site 1204

Cebu City, Cebu, Philippines

Site Status

Tanvex Investigational Site 1211

Cebu City, Cebu, Philippines

Site Status

Tanvex Investigational Site 1208

Quezon City, Manila, Philippines

Site Status

Tanvex Investigational Site 1207

Manila, National Capital Region, Philippines

Site Status

Tanvex Investigational Site 1206

Bacolod City, Negros Occidental, Philippines

Site Status

Tanvex Investigational Site 1212

Davao City, , Philippines

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Tanvex Investigational Site 1214

Makati City, , Philippines

Site Status

Tanvex Investigational Site 1201

Manila, , Philippines

Site Status

Tanvex Investigational Site 1209

Quezon City, , Philippines

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Tanvex Investigational Site 1213

Quezon City, , Philippines

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Tanvex Investigational Site 1522

Ufa, Bashkortostan Republic, Russia

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Tanvex Investigational Site 1529

Krasnodar, Krasnodarskiy Kray, Russia

Site Status

Tanvex Investigational Site 1513

Sochi, Krasnodarskiy Kray, Russia

Site Status

Tanvex Investigational Site 1509

Omsk, Omsk Oblast, Russia

Site Status

Tanvex Investigational Site 1510

Pushkin, Sankt-Peterburg, Russia

Site Status

Tanvex Investigational Site 1511

Novosibirsk, Siberia, Russia

Site Status

Tanvex Investigational Site 1519

Pyatigorsk, Stavropol Kray, Russia

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Tanvex Investigational Site 1518

Tomsk, Tomsk Oblast, Russia

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Tanvex Investigational Site 1535

Arkhangelsk, , Russia

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Tanvex Investigational Site 1531

Belgorod, , Russia

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Tanvex Investigational Site 1538

Chelyabinsk, , Russia

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Tanvex Investigational Site 1520

Ivanovo, , Russia

Site Status

Tanvex Investigational Site 1515

Izhevsk, , Russia

Site Status

Tanvex Investigational Site 1502

Kaluga, , Russia

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Tanvex Investigational Site 1540

Kazan', , Russia

Site Status

Tanvex Investigational Site 1512

Krasnoyarsk, , Russia

Site Status

Tanvex Investigational Site 1505

Kursk, , Russia

Site Status

Tanvex Investigational Site 1530

Moscow, , Russia

Site Status

Tanvex Investigational Site 1536

Moscow, , Russia

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Tanvex Investigational Site 1514

Moscow, , Russia

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Tanvex Investigational Site 1507

Moscow, , Russia

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Tanvex Investigational Site 1503

Omsk, , Russia

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Tanvex Investigational Site 1537

Orenburg, , Russia

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Tanvex Investigational Site 1521

Rostov-on-Don, , Russia

Site Status

Tanvex Investigational Site 1516

Saint Petersburg, , Russia

Site Status

Tanvex Investigational Site 1517

Saint Petersburg, , Russia

Site Status

Tanvex Investigational Site 1523

Saint Petersburg, , Russia

Site Status

Tanvex Investigational Site 1524

Saint Petersburg, , Russia

Site Status

Tanvex Investigational Site 1525

Saint Petersburg, , Russia

Site Status

Tanvex Investigational Site 1506

Saint Petersburg, , Russia

Site Status

Tanvex Investigational Site 1526

Saint Petersburg, , Russia

Site Status

Tanvex Investigational Site 1501

Saint Petersburg, , Russia

Site Status

Tanvex Investigational Site 1508

Saransk, , Russia

Site Status

Tanvex Investigational Site 1533

Tomsk, , Russia

Site Status

Tanvex Investigational Site 1534

Yaroslavl, , Russia

Site Status

Tanvex Investigational Site 1808

Chernihiv, , Ukraine

Site Status

Tanvex Investigational Site 1821

Chernivtsi, , Ukraine

Site Status

Tanvex Investigational Site 1803

Dnipro, , Ukraine

Site Status

Tanvex Investigational Site 1824

Dnipro, , Ukraine

Site Status

Tanvex Investigational Site 1820

Kherson, , Ukraine

Site Status

Tanvex Investigational Site 1812

Khmelnytskyi, , Ukraine

Site Status

Tanvex Investigational Site 1815

Kiev, , Ukraine

Site Status

Tanvex Investigational Site 1811

Kiev, , Ukraine

Site Status

Tanvex Investigational Site 1802

Kiev, , Ukraine

Site Status

Tanvex Investigational Site 1814

Kropyvnytskyi, , Ukraine

Site Status

Tanvex Investigational Site 1819

Kropyvnytskyi, , Ukraine

Site Status

Tanvex Investigational Site 1804

Kryvyi Rih, , Ukraine

Site Status

Tanvex Investigational Site 1809

Kyiv, , Ukraine

Site Status

Tanvex Investigational Site 1810

Odesa, , Ukraine

Site Status

Tanvex Investigational Site 1806

Sumy, , Ukraine

Site Status

Tanvex Investigational Site 1822

Ternopil, , Ukraine

Site Status

Tanvex Investigational Site 1823

Uzhhorod, , Ukraine

Site Status

Tanvex Investigational Site 1818

Vinnitsya, , Ukraine

Site Status

Tanvex Investigational Site 1813

Zaporizhzhia, , Ukraine

Site Status

Countries

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Belarus Chile Georgia Hungary India Mexico Peru Philippines Russia Ukraine

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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TX05-03

Identifier Type: -

Identifier Source: org_study_id

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