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

January 7, 2022 updated by: Tanvex BioPharma USA, Inc.

A Randomized, Double-blind, Parallel Group, Phase III Trial to Compare the Efficacy, Safety, and Immunogenicity of TX05 With Herceptin® in Subjects With HER2 Positive Early Breast Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

809

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Gomel, Belarus, 246012
        • Tanvex Investigational Site 1003
      • Grodno, Belarus, 230017
        • Tanvex Investigational Site 1006
      • Minsk, Belarus, 220013
        • Tanvex Investigational Site 1002
      • Mogilev, Belarus, 2120018
        • Tanvex Investigational Site 1005
      • Vitebsk, Belarus, 21008
        • Tanvex Investigational Site 1001
    • Minsk Region
      • Lesnoy, Minsk Region, Belarus, 223040
        • Tanvex Investigational Site 1008
    • Mogilev Region
      • Babruysk, Mogilev Region, Belarus, 213825
        • Tanvex Investigational Site 1007
  • Chile
      • Temuco, Chile, 4810469
        • Tanvex Investigational Site 4001
      • Viña Del Mar, Chile, 2520598
        • Tanvex Investigational Site 4002
  • Georgia
      • Batumi, Georgia, 6000
        • Tanvex Investigational Site 5006
      • Batumi, Georgia, 6010
        • Tanvex Investigational Site 5002
      • Tbilisi, Georgia, 0144
        • Tanvex Investigational Site 5003
      • Tbilisi, Georgia, 0159
        • Tanvex Investigational Site 5001
      • Tbilisi, Georgia, 0159
        • Tanvex Investigational Site 5005
      • Tbilisi, Georgia, 0159
        • Tanvex Investigational Site 5012
      • Tbilisi, Georgia, 0177
        • Tanvex Investigational Site 5013
      • Tbilisi, Georgia, 0179
        • Tanvex Investigational Site 5004
      • Tbilisi, Georgia, 0186
        • Tanvex Investigational Site 5010
      • Tbilisi, Georgia, 0186
        • Tanvex Investigational Site 5011
      • Tbilisi, Georgia, 112
        • Tanvex Investigational Site 5008
      • Tbilisi, Georgia, 131
        • Tanvex Investigational Site 5009
      • Tbilisi, Georgia, 141
        • Tanvex Investigational Site 5007
  • Hungary
      • Budapest, Hungary, 1122
        • Tanvex Investigational Site 6003
      • Budapest, Hungary, 1122
        • Tanvex Investigational Site 6007
      • Debrecen, Hungary, 4032
        • Tanvex Investigational Site 6005
      • Győr, Hungary, 9024
        • Tanvex Investigational Site 6006
      • Miskolc, Hungary, 3526
        • Tanvex Investigational Site 6004
      • Pécs, Hungary, 7264
        • Tanvex Investigational Site 6001
  • India
      • Ahmedabad, India, 380016
        • Tanvex Invesitgational Site 7033
      • Bangalore, India, 560027
        • Tanvex Investigational Site 7019
      • Bangalore, India, 560072
        • Tanvex Investigational Site 7037
      • Belgaum, India, 590010
        • Tanvex Investigational Site 7022
      • Chandigarh, India, 160012
        • Tanvex Investigational Site 7034
      • Coimbatore, India, 641037
        • Tanvex Investigational Site 7013
      • Gurgaon, India, 122001
        • Tanvex Investigational Site 7024
      • Hyderabad, India, 500004
        • Tanvex Investigational Site 7045
      • Hyderabad, India, 500034
        • Tanvex Investigational Site 7036
      • Jaipur, India, 302004
        • Tanvex Investigational Site 7009
      • Kolkata, India, 700014
        • Tanvex Investigational Site 7039
      • Kolkata, India, 700094
        • Tanvex Investigational Site 7040
      • Kolkata, India, 700099
        • Tanvex Investigational Site 7006
      • Lucknow, India, 226003
        • Tanvex Investigational Site 7005
      • Manipala, India, 576104
        • Tanvex Investigational Site 7012
      • Model Town, India, 141002
        • Tanvex Investigational Site 7041
      • Naka, India, 422004
        • Tanvex Investigational Site 7031
      • Nashik, India, 422002
        • Tanvex Investigational Site 7001
      • Trichy, India, 620008
        • Tanvex Investigational Site 7042
      • Vadodara, India, 390007
        • Tanvex Investigational Site 7018
      • Vijayawada, India, 520002
        • Tanvex Investigational Site 7017
    • Maharashtra
      • Nashik, Maharashtra, India, 422005
        • Tanvex Investigational Site 7007
      • Pune, Maharashtra, India, 411001
        • Tanvex Investigational Site 7015
      • Pune, Maharashtra, India, 411004
        • Tanvex Investigational Site 7003
      • Pune, Maharashtra, India, 411004
        • Tanvex Investigational Site 7004
    • Rajasthan
      • Bīkaner, Rajasthan, India, 334003
        • Tanvex Investigational Site 7002
    • Tamil Nadu
      • Madurai, Tamil Nadu, India, 625107
        • Tanvex Investigational Site 7010
  • Mexico
      • Aguascalientes, Mexico, 20127
        • Tanvex Investigational Site 2117
      • Aguascalientes, Mexico, 20234
        • Tanvex Investigational Site 2109
      • Cancun, Mexico, 77506
        • Tanvex Investigational Site 2116
      • Ciudad de mexico, Mexico, 06760
        • Tanvex Investigational Site 2111
      • Cuauhtemoc, Mexico, 06100
        • Tanvex Investigational Site 2104
      • Cuauhtémoc, Mexico, 06760
        • Tanvex Investigational Site 2114
      • Cuautitlán Izcalli, Mexico, 54769
        • Tanvex Investigational Site 2101
      • Mexico, Mexico, 06100
        • Tanvex Investigational Site 2113
      • Monterrey, Mexico, 64320
        • Tanvex Investigational Site 2103
      • Oaxaca, Mexico, 68000
        • Tanvex Investigational Site 2106
      • San Luis Potosí, Mexico, 78200
        • Tanvex Investigational Site 2112
      • Tequisquiapan, Mexico, 76750
        • Tanvex Investigational Site 2110
      • Zapopan, Mexico, 45030
        • Tanvex Investigational Site 2108
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64000
        • Tanvex Investigational Site 2102
  • Peru
      • Arequipa, Peru, 04001
        • Tanvex Investigational Site 1101
      • Arequipa, Peru, 04001
        • Tanvex Investigational Site 1107
      • Lima, Peru, 15046
        • Tanvex Investigational Site 1110
      • San Isidro, Peru, 15036
        • Tanvex Investigational Site 1105
      • San Isidro, Peru, 15073
        • Tanvex Investigational Site 1102
      • Surquillo, Peru, 15038
        • Tanvex Investigational Site 1109
      • Trujillo, Peru, 13001
        • Tanvex Investigational Site 1103
    • Lambayeque
      • Chiclayo, Lambayeque, Peru, 14001
        • Tanvex Investigational Site 1104
    • Lima
      • Lima Cercado, Lima, Peru, 15082
        • Tanvex Investigational Site 1112
      • San Borja, Lima, Peru, 15036
        • Tanvex Investigational Site 1108
      • San Borja, Lima, Peru, 15036
        • Tanvex Investigational Site 1113
  • Philippines
      • Davao City, Philippines, 8000
        • Tanvex Investigational Site 1212
      • Makati City, Philippines, 1229
        • Tanvex Investigational Site 1214
      • Manila, Philippines, 1000
        • Tanvex Investigational Site 1201
      • Quezon City, Philippines, 1101
        • Tanvex Investigational Site 1209
      • Quezon City, Philippines, 1102
        • Tanvex Investigational Site 1213
    • Batangas
      • Santo Tomas, Batangas, Philippines, 4234
        • Tanvex Investigational Site 1210
    • Cebu
      • Cebu City, Cebu, Philippines, 6000
        • Tanvex Investigational Site 1203
      • Cebu City, Cebu, Philippines, 6000
        • Tanvex Investigational Site 1204
      • Cebu City, Cebu, Philippines, 6000
        • Tanvex Investigational Site 1211
    • Manila
      • Quezon City, Manila, Philippines, 1110
        • Tanvex Investigational Site 1208
    • Metro Manila
      • Manila, Metro Manila, Philippines, 1000
        • Tanvex Investigational Site 1207
    • Negros Occidental
      • Bacolod City, Negros Occidental, Philippines, 6100
        • Tanvex Investigational Site 1206
  • Russian Federation
      • Arkhangel'sk, Russian Federation, 163045
        • Tanvex Investigational Site 1535
      • Belgorod, Russian Federation, 308010
        • Tanvex Investigational Site 1531
      • Chelyabinsk, Russian Federation, 454048
        • Tanvex Investigational Site 1538
      • Ivanovo, Russian Federation, 153040
        • Tanvex Investigational Site 1520
      • Izhevsk, Russian Federation, 426009
        • Tanvex Investigational Site 1515
      • Kaluga, Russian Federation, 248007
        • Tanvex Investigational Site 1502
      • Kazan, Russian Federation, 420029
        • Tanvex Investigational Site 1540
      • Krasnoyarsk, Russian Federation, 660133
        • Tanvex Investigational Site 1512
      • Kursk, Russian Federation, 305035
        • Tanvex Investigational Site 1505
      • Moscow, Russian Federation, 121467
        • Tanvex Investigational Site 1530
      • Moscow, Russian Federation, 125284
        • Tanvex Investigational Site 1536
      • Moscow, Russian Federation, 129128
        • Tanvex Investigational Site 1514
      • Moscow, Russian Federation, 129515
        • Tanvex Investigational Site 1507
      • Omsk, Russian Federation, 644013
        • Tanvex Investigational Site 1503
      • Orenburg, Russian Federation, 460021
        • Tanvex Investigational Site 1537
      • Rostov-Na-Donu, Russian Federation, 344037
        • Tanvex Investigational Site 1521
      • Saint Petersburg, Russian Federation, 191015
        • Tanvex Investigational Site 1516
      • Saint Petersburg, Russian Federation, 191025
        • Tanvex Investigational Site 1517
      • Saint Petersburg, Russian Federation, 191104
        • Tanvex Investigational Site 1523
      • Saint Petersburg, Russian Federation, 196247
        • Tanvex Investigational Site 1525
      • Saint Petersburg, Russian Federation, 197758
        • Tanvex Investigational Site 1506
      • Saint Petersburg, Russian Federation, 197758
        • Tanvex Investigational Site 1526
      • Saint Petersburg, Russian Federation, 198255
        • Tanvex Investigational Site 1501
      • Saint-Petersburg, Russian Federation, 195271
        • Tanvex Investigational Site 1524
      • Saransk, Russian Federation, 430032
        • Tanvex Investigational Site 1508
      • Tomsk, Russian Federation, 634009
        • Tanvex Investigational Site 1533
      • Yaroslavl, Russian Federation, 150054
        • Tanvex Investigational Site 1534
    • Krasnodar Region
      • Krasnodar, Krasnodar Region, Russian Federation, 350040
        • Tanvex Investigational Site 1529
      • Sochi, Krasnodar Region, Russian Federation, 354057
        • Tanvex Investigational Site 1513
    • Omsk Region
      • Omsk, Omsk Region, Russian Federation, 644013
        • Tanvex Investigational Site 1509
    • Republic Of Bashkortostan
      • Ufa, Republic Of Bashkortostan, Russian Federation, 450054
        • Tanvex Investigational Site 1522
    • Saint Petersburg
      • Pushkin, Saint Petersburg, Russian Federation, 196603
        • Tanvex Investigational Site 1510
    • Siberia
      • Novosibirsk, Siberia, Russian Federation, 630099
        • Tanvex Investigational Site 1511
    • Stavropol Region
      • Pyatigorsk, Stavropol Region, Russian Federation, 357502
        • Tanvex Investigational Site 1519
    • Tomsk Region
      • Tomsk, Tomsk Region, Russian Federation, 634050
        • Tanvex Investigational Site 1518
  • Ukraine
      • Chernihiv, Ukraine, 14029
        • Tanvex Investigational Site 1808
      • Chernivtsi, Ukraine, 58013
        • Tanvex Investigational Site 1821
      • Dnepropetrovsk, Ukraine, 49102
        • Tanvex Investigational Site 1803
      • Dnipro, Ukraine, 49600
        • Tanvex Investigational Site 1824
      • Kherson, Ukraine, 73000
        • Tanvex Investigational Site 1820
      • Khmelnytskyi, Ukraine, 29000
        • Tanvex Investigational Site 1812
      • Kiev, Ukraine, 03022
        • Tanvex Investigational Site 1815
      • Kiev, Ukraine, 03115
        • Tanvex Investigational Site 1811
      • Kiev, Ukraine, 04107
        • Tanvex Investigational Site 1802
      • Kirovogrado, Ukraine, 25000
        • Tanvex Investigational Site 1814
      • Kropyvnytskyi, Ukraine, 25006
        • Tanvex Investigational Site 1819
      • Kryvyi Rih, Ukraine, 50048
        • Tanvex Investigational Site 1804
      • Kyiv, Ukraine, 03126
        • Tanvex Investigational Site 1809
      • Odesa, Ukraine, 65055
        • Tanvex Investigational Site 1810
      • Sumy, Ukraine, 40022
        • Tanvex Investigational Site 1806
      • Ternopil', Ukraine, 46023
        • Tanvex Investigational Site 1822
      • Vinnitsya, Ukraine, 21029
        • Tanvex Investigational Site 1818
      • Zaporizhzhia, Ukraine, 69104
        • Tanvex Investigational Site 1813
      • Úzhgorod, Ukraine, 88000
        • Tanvex Investigational Site 1823

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Key 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.

Key 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Biological: TX05 (trastuzumab)
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)
Other Names:
  • Ribotax
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)
Active Comparator: 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
Drug: Paclitaxel
175 mg/m^2, 60 min IV infusion, every 3 weeks (Cycles 5-8)
Other Names:
  • Ribotax
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)
Biological: Herceptin®
8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Subjects in Each Treatment Arm Who Achieve Pathologic Complete Response (pCR)
Time Frame: 3-7 weeks following last dose of study treatment
Pathologic complete response was determined by central review and defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled lymph nodes following neoadjuvant systemic therapy (ypT0/Tis ypN0).
3-7 weeks following last dose of study treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: End of Treatment (Week 24) or Early Termination Visit
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (ORR) = CR + PR.
End of Treatment (Week 24) or Early Termination Visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanvex BioPharma USA, Inc.

Investigators

  • Study Director: Bonnie Mills, PhD, Tanvex BioPharma USA, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2018

Primary Completion (Actual)

November 27, 2020

Study Completion (Actual)

February 4, 2021

Study Registration Dates

First Submitted

June 1, 2018

First Submitted That Met QC Criteria

June 12, 2018

First Posted (Actual)

June 14, 2018

Study Record Updates

Last Update Posted (Actual)

January 14, 2022

Last Update Submitted That Met QC Criteria

January 7, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TX05-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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