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

Primary Purpose

Breast Cancer, Breast Neoplasms, HER2-positive Breast Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
TX05 (trastuzumab)
Herceptin®
Paclitaxel
Epirubicin
Cyclophosphamide
Sponsored by
Tanvex BioPharma USA, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring trastuzumab, Herceptin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Tanvex Investigational Site 1008
  • Tanvex Investigational Site 1007
  • Tanvex Investigational Site 1003
  • Tanvex Investigational Site 1006
  • Tanvex Investigational Site 1002
  • Tanvex Investigational Site 1005
  • Tanvex Investigational Site 1001
  • Tanvex Investigational Site 4001
  • Tanvex Investigational Site 4002
  • Tanvex Investigational Site 5006
  • Tanvex Investigational Site 5002
  • Tanvex Investigational Site 5003
  • Tanvex Investigational Site 5001
  • Tanvex Investigational Site 5005
  • Tanvex Investigational Site 5012
  • Tanvex Investigational Site 5013
  • Tanvex Investigational Site 5004
  • Tanvex Investigational Site 5010
  • Tanvex Investigational Site 5011
  • Tanvex Investigational Site 5008
  • Tanvex Investigational Site 5009
  • Tanvex Investigational Site 5007
  • Tanvex Investigational Site 6003
  • Tanvex Investigational Site 6007
  • Tanvex Investigational Site 6005
  • Tanvex Investigational Site 6006
  • Tanvex Investigational Site 6004
  • Tanvex Investigational Site 6001
  • Tanvex Investigational Site 7007
  • Tanvex Investigational Site 7015
  • Tanvex Investigational Site 7003
  • Tanvex Investigational Site 7004
  • Tanvex Investigational Site 7002
  • Tanvex Investigational Site 7010
  • Tanvex Invesitgational Site 7033
  • Tanvex Investigational Site 7019
  • Tanvex Investigational Site 7037
  • Tanvex Investigational Site 7022
  • Tanvex Investigational Site 7034
  • Tanvex Investigational Site 7013
  • Tanvex Investigational Site 7024
  • Tanvex Investigational Site 7045
  • Tanvex Investigational Site 7036
  • Tanvex Investigational Site 7009
  • Tanvex Investigational Site 7039
  • Tanvex Investigational Site 7040
  • Tanvex Investigational Site 7006
  • Tanvex Investigational Site 7005
  • Tanvex Investigational Site 7012
  • Tanvex Investigational Site 7041
  • Tanvex Investigational Site 7031
  • Tanvex Investigational Site 7001
  • Tanvex Investigational Site 7042
  • Tanvex Investigational Site 7018
  • Tanvex Investigational Site 7017
  • Tanvex Investigational Site 2102
  • Tanvex Investigational Site 2117
  • Tanvex Investigational Site 2109
  • Tanvex Investigational Site 2116
  • Tanvex Investigational Site 2111
  • Tanvex Investigational Site 2104
  • Tanvex Investigational Site 2114
  • Tanvex Investigational Site 2101
  • Tanvex Investigational Site 2113
  • Tanvex Investigational Site 2103
  • Tanvex Investigational Site 2106
  • Tanvex Investigational Site 2112
  • Tanvex Investigational Site 2110
  • Tanvex Investigational Site 2108
  • Tanvex Investigational Site 1104
  • Tanvex Investigational Site 1112
  • Tanvex Investigational Site 1108
  • Tanvex Investigational Site 1113
  • Tanvex Investigational Site 1101
  • Tanvex Investigational Site 1107
  • Tanvex Investigational Site 1110
  • Tanvex Investigational Site 1105
  • Tanvex Investigational Site 1102
  • Tanvex Investigational Site 1109
  • Tanvex Investigational Site 1103
  • Tanvex Investigational Site 1210
  • Tanvex Investigational Site 1203
  • Tanvex Investigational Site 1204
  • Tanvex Investigational Site 1211
  • Tanvex Investigational Site 1208
  • Tanvex Investigational Site 1207
  • Tanvex Investigational Site 1206
  • Tanvex Investigational Site 1212
  • Tanvex Investigational Site 1214
  • Tanvex Investigational Site 1201
  • Tanvex Investigational Site 1209
  • Tanvex Investigational Site 1213
  • Tanvex Investigational Site 1529
  • Tanvex Investigational Site 1513
  • Tanvex Investigational Site 1509
  • Tanvex Investigational Site 1522
  • Tanvex Investigational Site 1510
  • Tanvex Investigational Site 1511
  • Tanvex Investigational Site 1519
  • Tanvex Investigational Site 1518
  • Tanvex Investigational Site 1535
  • Tanvex Investigational Site 1531
  • Tanvex Investigational Site 1538
  • Tanvex Investigational Site 1520
  • Tanvex Investigational Site 1515
  • Tanvex Investigational Site 1502
  • Tanvex Investigational Site 1540
  • Tanvex Investigational Site 1512
  • Tanvex Investigational Site 1505
  • Tanvex Investigational Site 1530
  • Tanvex Investigational Site 1536
  • Tanvex Investigational Site 1514
  • Tanvex Investigational Site 1507
  • Tanvex Investigational Site 1503
  • Tanvex Investigational Site 1537
  • Tanvex Investigational Site 1521
  • Tanvex Investigational Site 1516
  • Tanvex Investigational Site 1517
  • Tanvex Investigational Site 1523
  • Tanvex Investigational Site 1525
  • Tanvex Investigational Site 1506
  • Tanvex Investigational Site 1526
  • Tanvex Investigational Site 1501
  • Tanvex Investigational Site 1524
  • Tanvex Investigational Site 1508
  • Tanvex Investigational Site 1533
  • Tanvex Investigational Site 1534
  • Tanvex Investigational Site 1808
  • Tanvex Investigational Site 1821
  • Tanvex Investigational Site 1803
  • Tanvex Investigational Site 1824
  • Tanvex Investigational Site 1820
  • Tanvex Investigational Site 1812
  • Tanvex Investigational Site 1815
  • Tanvex Investigational Site 1811
  • Tanvex Investigational Site 1802
  • Tanvex Investigational Site 1814
  • Tanvex Investigational Site 1819
  • Tanvex Investigational Site 1804
  • Tanvex Investigational Site 1809
  • Tanvex Investigational Site 1810
  • Tanvex Investigational Site 1806
  • Tanvex Investigational Site 1822
  • Tanvex Investigational Site 1818
  • Tanvex Investigational Site 1813
  • Tanvex Investigational Site 1823

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TX05 (trastuzumab)

Herceptin®

Arm Description

• 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

• 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

Outcomes

Primary Outcome Measures

Proportion of Subjects in Each Treatment Arm Who Achieve Pathologic Complete Response (pCR)
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).

Secondary Outcome Measures

Objective Response Rate (ORR)
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.

Full Information

First Posted
June 1, 2018
Last Updated
January 7, 2022
Sponsor
Tanvex BioPharma USA, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03556358
Brief Title
Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
June 28, 2018 (Actual)
Primary Completion Date
November 27, 2020 (Actual)
Study Completion Date
February 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tanvex BioPharma USA, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast Neoplasms, HER2-positive Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer
Keywords
trastuzumab, Herceptin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
809 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TX05 (trastuzumab)
Arm Type
Experimental
Arm Description
• 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
Arm Title
Herceptin®
Arm Type
Active Comparator
Arm Description
• 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
Intervention Type
Biological
Intervention Name(s)
TX05 (trastuzumab)
Intervention Description
8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)
Intervention Type
Biological
Intervention Name(s)
Herceptin®
Intervention Description
8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Ribotax
Intervention Description
175 mg/m^2, 60 min IV infusion, every 3 weeks (Cycles 5-8)
Intervention Type
Drug
Intervention Name(s)
Epirubicin
Intervention Description
75 mg/m^2, IV bolus infusion, every 3 weeks (Cycles 1-4)
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
600 mg/m^2, 30 min IV infusion, every 3 weeks (Cycles 1-4)
Primary Outcome Measure Information:
Title
Proportion of Subjects in Each Treatment Arm Who Achieve Pathologic Complete Response (pCR)
Description
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).
Time Frame
3-7 weeks following last dose of study treatment
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
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.
Time Frame
End of Treatment (Week 24) or Early Termination Visit

10. Eligibility

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

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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