Clinical trial NCT03556358: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Breast Neoplasms
HER2-positive Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Keywords: trastuzumab
Herceptin
Lead sponsor: Tanvex BioPharma USA, Inc.
Sponsor class: INDUSTRY
First posted: 2018-06-14
Enrollment: 809
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Proportion of Subjects in Each Treatment Arm Who Achieve Pathologic Complete Response (pCR)
timeFrame: 3-7 weeks following last dose of study treatment
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: End of Treatment (Week 24) or Early Termination Visit
Other outcomes:
Locations:
city: Lesnoy
country: Belarus
facility: Tanvex Investigational Site 1008
state: Minsk Region
city: Babruysk
country: Belarus
facility: Tanvex Investigational Site 1007
state: Mogilev Region
city: Gomel
country: Belarus
facility: Tanvex Investigational Site 1003
city: Grodno
country: Belarus
facility: Tanvex Investigational Site 1006
city: Minsk
country: Belarus
facility: Tanvex Investigational Site 1002
city: Mogilev
country: Belarus
facility: Tanvex Investigational Site 1005
city: Vitebsk
country: Belarus
facility: Tanvex Investigational Site 1001
city: Temuco
country: Chile
facility: Tanvex Investigational Site 4001
city: Viña Del Mar
country: Chile
facility: Tanvex Investigational Site 4002
city: Batumi
country: Georgia
facility: Tanvex Investigational Site 5006
city: Batumi
country: Georgia
facility: Tanvex Investigational Site 5002
city: Tbilisi
country: Georgia
facility: Tanvex Investigational Site 5003
city: Tbilisi
country: Georgia
facility: Tanvex Investigational Site 5001
city: Tbilisi
country: Georgia
facility: Tanvex Investigational Site 5005
city: Tbilisi
country: Georgia
facility: Tanvex Investigational Site 5012
city: Tbilisi
country: Georgia
facility: Tanvex Investigational Site 5013
city: Tbilisi
country: Georgia
facility: Tanvex Investigational Site 5004
city: Tbilisi
country: Georgia
facility: Tanvex Investigational Site 5010
city: Tbilisi
country: Georgia
facility: Tanvex Investigational Site 5011
city: Tbilisi
country: Georgia
facility: Tanvex Investigational Site 5008
city: Tbilisi
country: Georgia
facility: Tanvex Investigational Site 5009
city: Tbilisi
country: Georgia
facility: Tanvex Investigational Site 5007
city: Budapest
country: Hungary
facility: Tanvex Investigational Site 6003
city: Budapest
country: Hungary
facility: Tanvex Investigational Site 6007
city: Debrecen
country: Hungary
facility: Tanvex Investigational Site 6005
city: Győr
country: Hungary
facility: Tanvex Investigational Site 6006
city: Miskolc
country: Hungary
facility: Tanvex Investigational Site 6004
city: Pécs
country: Hungary
facility: Tanvex Investigational Site 6001
city: Nashik
country: India
facility: Tanvex Investigational Site 7007
state: Maharashtra
city: Pune
country: India
facility: Tanvex Investigational Site 7015
state: Maharashtra
city: Pune
country: India
facility: Tanvex Investigational Site 7003
state: Maharashtra
city: Pune
country: India
facility: Tanvex Investigational Site 7004
state: Maharashtra
city: Bīkaner
country: India
facility: Tanvex Investigational Site 7002
state: Rajasthan
city: Madurai
country: India
facility: Tanvex Investigational Site 7010
state: Tamil Nadu
city: Ahmedabad
country: India
facility: Tanvex Invesitgational Site 7033
city: Bangalore
country: India
facility: Tanvex Investigational Site 7019
city: Bangalore
country: India
facility: Tanvex Investigational Site 7037
city: Belgaum
country: India
facility: Tanvex Investigational Site 7022
city: Chandigarh
country: India
facility: Tanvex Investigational Site 7034
city: Coimbatore
country: India
facility: Tanvex Investigational Site 7013
city: Gurgaon
country: India
facility: Tanvex Investigational Site 7024
city: Hyderabad
country: India
facility: Tanvex Investigational Site 7045
city: Hyderabad
country: India
facility: Tanvex Investigational Site 7036
city: Jaipur
country: India
facility: Tanvex Investigational Site 7009
city: Kolkata
country: India
facility: Tanvex Investigational Site 7039
city: Kolkata
country: India
facility: Tanvex Investigational Site 7040
city: Kolkata
country: India
facility: Tanvex Investigational Site 7006
city: Lucknow
country: India
facility: Tanvex Investigational Site 7005
city: Manipala
country: India
facility: Tanvex Investigational Site 7012
city: Model Town
country: India
facility: Tanvex Investigational Site 7041
city: Naka
country: India
facility: Tanvex Investigational Site 7031
city: Nashik
country: India
facility: Tanvex Investigational Site 7001
city: Trichy
country: India
facility: Tanvex Investigational Site 7042
city: Vadodara
country: India
facility: Tanvex Investigational Site 7018
city: Vijayawada
country: India
facility: Tanvex Investigational Site 7017
city: Monterrey
country: Mexico
facility: Tanvex Investigational Site 2102
state: Nuevo León
city: Aguascalientes
country: Mexico
facility: Tanvex Investigational Site 2117
city: Aguascalientes
country: Mexico
facility: Tanvex Investigational Site 2109
city: Cancun
country: Mexico
facility: Tanvex Investigational Site 2116
city: Ciudad de mexico
country: Mexico
facility: Tanvex Investigational Site 2111
city: Cuauhtemoc
country: Mexico
facility: Tanvex Investigational Site 2104
city: Cuauhtémoc
country: Mexico
facility: Tanvex Investigational Site 2114
city: Cuautitlán Izcalli
country: Mexico
facility: Tanvex Investigational Site 2101
city: Mexico
country: Mexico
facility: Tanvex Investigational Site 2113
city: Monterrey
country: Mexico
facility: Tanvex Investigational Site 2103
city: Oaxaca
country: Mexico
facility: Tanvex Investigational Site 2106
city: San Luis Potosí
country: Mexico
facility: Tanvex Investigational Site 2112
city: Tequisquiapan
country: Mexico
facility: Tanvex Investigational Site 2110
city: Zapopan
country: Mexico
facility: Tanvex Investigational Site 2108
city: Chiclayo
country: Peru
facility: Tanvex Investigational Site 1104
state: Lambayeque
city: Lima Cercado
country: Peru
facility: Tanvex Investigational Site 1112
state: Lima
city: San Borja
country: Peru
facility: Tanvex Investigational Site 1108
state: Lima
city: San Borja
country: Peru
facility: Tanvex Investigational Site 1113
state: Lima
city: Arequipa
country: Peru
facility: Tanvex Investigational Site 1101
city: Arequipa
country: Peru
facility: Tanvex Investigational Site 1107
city: Lima
country: Peru
facility: Tanvex Investigational Site 1110
city: San Isidro
country: Peru
facility: Tanvex Investigational Site 1105
city: San Isidro
country: Peru
facility: Tanvex Investigational Site 1102
city: Surquillo
country: Peru
facility: Tanvex Investigational Site 1109
city: Trujillo
country: Peru
facility: Tanvex Investigational Site 1103
city: Santo Tomas
country: Philippines
facility: Tanvex Investigational Site 1210
state: Batangas
city: Cebu City
country: Philippines
facility: Tanvex Investigational Site 1203
state: Cebu
city: Cebu City
country: Philippines
facility: Tanvex Investigational Site 1204
state: Cebu
city: Cebu City
country: Philippines
facility: Tanvex Investigational Site 1211
state: Cebu
city: Quezon City
country: Philippines
facility: Tanvex Investigational Site 1208
state: Manila
city: Manila
country: Philippines
facility: Tanvex Investigational Site 1207
state: Metro Manila
city: Bacolod City
country: Philippines
facility: Tanvex Investigational Site 1206
state: Negros Occidental
city: Davao City
country: Philippines
facility: Tanvex Investigational Site 1212
city: Makati City
country: Philippines
facility: Tanvex Investigational Site 1214
city: Manila
country: Philippines
facility: Tanvex Investigational Site 1201
city: Quezon City
country: Philippines
facility: Tanvex Investigational Site 1209
city: Quezon City
country: Philippines
facility: Tanvex Investigational Site 1213
city: Krasnodar
country: Russian Federation
facility: Tanvex Investigational Site 1529
state: Krasnodar Region
city: Sochi
country: Russian Federation
facility: Tanvex Investigational Site 1513
state: Krasnodar Region
city: Omsk
country: Russian Federation
facility: Tanvex Investigational Site 1509
state: Omsk Region
city: Ufa
country: Russian Federation
facility: Tanvex Investigational Site 1522
state: Republic Of Bashkortostan
city: Pushkin
country: Russian Federation
facility: Tanvex Investigational Site 1510
state: Saint Petersburg
city: Novosibirsk
country: Russian Federation
facility: Tanvex Investigational Site 1511
state: Siberia
city: Pyatigorsk
country: Russian Federation
facility: Tanvex Investigational Site 1519
state: Stavropol Region
city: Tomsk
country: Russian Federation
facility: Tanvex Investigational Site 1518
state: Tomsk Region
city: Arkhangel'sk
country: Russian Federation
facility: Tanvex Investigational Site 1535
city: Belgorod
country: Russian Federation
facility: Tanvex Investigational Site 1531
city: Chelyabinsk
country: Russian Federation
facility: Tanvex Investigational Site 1538
city: Ivanovo
country: Russian Federation
facility: Tanvex Investigational Site 1520
city: Izhevsk
country: Russian Federation
facility: Tanvex Investigational Site 1515
city: Kaluga
country: Russian Federation
facility: Tanvex Investigational Site 1502
city: Kazan
country: Russian Federation
facility: Tanvex Investigational Site 1540
city: Krasnoyarsk
country: Russian Federation
facility: Tanvex Investigational Site 1512
city: Kursk
country: Russian Federation
facility: Tanvex Investigational Site 1505
city: Moscow
country: Russian Federation
facility: Tanvex Investigational Site 1530
city: Moscow
country: Russian Federation
facility: Tanvex Investigational Site 1536
city: Moscow
country: Russian Federation
facility: Tanvex Investigational Site 1514
city: Moscow
country: Russian Federation
facility: Tanvex Investigational Site 1507
city: Omsk
country: Russian Federation
facility: Tanvex Investigational Site 1503
city: Orenburg
country: Russian Federation
facility: Tanvex Investigational Site 1537
city: Rostov-Na-Donu
country: Russian Federation
facility: Tanvex Investigational Site 1521
city: Saint Petersburg
country: Russian Federation
facility: Tanvex Investigational Site 1516
city: Saint Petersburg
country: Russian Federation
facility: Tanvex Investigational Site 1517
city: Saint Petersburg
country: Russian Federation
facility: Tanvex Investigational Site 1523
city: Saint Petersburg
country: Russian Federation
facility: Tanvex Investigational Site 1525
city: Saint Petersburg
country: Russian Federation
facility: Tanvex Investigational Site 1506
city: Saint Petersburg
country: Russian Federation
facility: Tanvex Investigational Site 1526
city: Saint Petersburg
country: Russian Federation
facility: Tanvex Investigational Site 1501
city: Saint-Petersburg
country: Russian Federation
facility: Tanvex Investigational Site 1524
city: Saransk
country: Russian Federation
facility: Tanvex Investigational Site 1508
city: Tomsk
country: Russian Federation
facility: Tanvex Investigational Site 1533
city: Yaroslavl
country: Russian Federation
facility: Tanvex Investigational Site 1534
city: Chernihiv
country: Ukraine
facility: Tanvex Investigational Site 1808
city: Chernivtsi
country: Ukraine
facility: Tanvex Investigational Site 1821
city: Dnepropetrovsk
country: Ukraine
facility: Tanvex Investigational Site 1803
city: Dnipro
country: Ukraine
facility: Tanvex Investigational Site 1824
city: Kherson
country: Ukraine
facility: Tanvex Investigational Site 1820
city: Khmelnytskyi
country: Ukraine
facility: Tanvex Investigational Site 1812
city: Kiev
country: Ukraine
facility: Tanvex Investigational Site 1815
city: Kiev
country: Ukraine
facility: Tanvex Investigational Site 1811
city: Kiev
country: Ukraine
facility: Tanvex Investigational Site 1802
city: Kirovogrado
country: Ukraine
facility: Tanvex Investigational Site 1814
city: Kropyvnytskyi
country: Ukraine
facility: Tanvex Investigational Site 1819
city: Kryvyi Rih
country: Ukraine
facility: Tanvex Investigational Site 1804
city: Kyiv
country: Ukraine
facility: Tanvex Investigational Site 1809
city: Odesa
country: Ukraine
facility: Tanvex Investigational Site 1810
city: Sumy
country: Ukraine
facility: Tanvex Investigational Site 1806
city: Ternopil'
country: Ukraine
facility: Tanvex Investigational Site 1822
city: Vinnitsya
country: Ukraine
facility: Tanvex Investigational Site 1818
city: Zaporizhzhia
country: Ukraine
facility: Tanvex Investigational Site 1813
city: Úzhgorod
country: Ukraine
facility: Tanvex Investigational Site 1823
Study officials:
affiliation: Tanvex BioPharma USA, Inc.
name: Bonnie Mills, PhD
role: STUDY_DIRECTOR
References: