Clinical trial NCT04109391: Extension Study to Provide Adjuvant Treatment Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03
Official title: A Double-blinded Extension Study to Provide Adjuvant Treatment With Single Agent Herceptin® or TX05 and Assess Continued Safety and Immunogenicity in Subjects With HER2-positive Early Breast Cancer Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HER2-positive Breast Cancer
Early-stage Breast Cancer
Breast Cancer
Breast Neoplasms
Stage II Breast Cancer
Stage IIIA Breast Cancer
Lead sponsor: Tanvex BioPharma USA, Inc.
Sponsor class: INDUSTRY
First posted: 2019-09-30
Enrollment: 338
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 an extension study to provide adjuvant treatment with single agent Herceptin or TX05 and assess continued safety and immunogenicity in subjects with HER2-positive early breast cancer following neoadjuvant treatment and surgical resection in Protocol TX05-03.


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent.
* Females ≥ 18 years of age.
* Completed neoadjuvant treatment (regardless of treatment arm) in the TX05/ Herceptin neoadjuvant study and the investigator believes the subject requires continued access to single agent trastuzumab in order to continue deriving clinical benefit.
* Successfully undergone surgical resection of their primary tumor with no evidence of residual disease (as determined by local assessment) and no other adjuvant therapy, other than trastuzumab, is planned. However, subjects will be allowed to receive hormonal therapy if they have hormone receptor positive tumors. Subjects will also be allowed to receive adjuvant radiation therapy, if required by their treating physician.
* Able to comply with the study protocol.
* Female subjects of childbearing potential must have a negative serum pregnancy test within 14 days of first administration of study drug and agree to use effective contraception (hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide) throughout the study period and for 7 months after last administration of study drug.

Exclusion Criteria:

* Breast cancer metastases or residual disease post operatively (as determined by local assessment).
* History or presence of a medical condition or disease that in the investigator's opinion would place the subject at an unacceptable risk for study participation.
* Lactating or pregnant female.
* Women of childbearing potential who do not consent to use highly effective methods of birth control (e.g. true abstinence \[periodic abstinence {e.g. calendar ovulation, symptothermal, post-ovulation methods} and withdrawal are not acceptable methods of contraception\], sterilization, or other non-hormonal forms of contraception) during treatment and for at least 7 months after the last administration of study drug. Subjects must agree to not breast-feed while receiving study drug.
* Any condition that in the opinion of the Investigator represents an obstacle for study conduct and/or represents a potential unacceptable risk for subjects.

Primary outcomes:
measure: Immunogenicity Assessments (ADA and Nab)
timeFrame: Assessed from first infusion through end of treatment (Week 45) or Early Termination visit. Each cycle is 3 weeks.
measure: Disease-Free Survival
timeFrame: Through study completion/end of treatment (Week 45).
measure: Overall Survival
timeFrame: Through study completion/end of treatment (Week 45).
Secondary outcomes:
Other outcomes:
Locations:
city: Gomel
country: Belarus
facility: Tanvex Investigational Site 1003E
city: Grodno
country: Belarus
facility: Tanvex Investigational Site 1006E
city: Lesnoy
country: Belarus
facility: Tanvex Investigational Site 1008E
city: Minsk
country: Belarus
facility: Tanvex Investigational Site 1002E
city: Mogilev
country: Belarus
facility: Tanvex Investigational Site 1005E
city: Vitebsk
country: Belarus
facility: Tanvex Investigational Site 1001E
city: Temuco
country: Chile
facility: Tanvex Investigational Site 4001E
city: Vina del Mar
country: Chile
facility: Tanvex Investigational Site 4002E
city: Batumi
country: Georgia
facility: Tanvex Investigational Site 5006E
city: Batumi
country: Georgia
facility: Tanvex Investigational Site 5002E
city: Tbilisi
country: Georgia
facility: Tanvex Investigational Site 5001E
city: Tbilisi
country: Georgia
facility: Tanvex Investigational Site 5005E
city: Tbilisi
country: Georgia
facility: Tanvex Investigational Site 5010E
city: Tbilisi
country: Georgia
facility: Tanvex Investigational Site 5008E
city: Budapest
country: Hungary
facility: Tanvex Investigational Site 6003E
city: Nashik
country: India
facility: Tanvex Investigational Site 7031E
state: Maharashtra
city: Ahmedabad
country: India
facility: Tanvex Investigational Site 7033E
city: Bangalore
country: India
facility: Tanvex Investigational Site 7019E
city: Belgaum
country: India
facility: Tanvex Investigational Site 7022E
city: Hyderabad
country: India
facility: Tanvex Investigational Site 7045E
city: Hyderabad
country: India
facility: Tanvex Investigational Site 7036E
city: Kolkata
country: India
facility: Tanvex Investigational Site 7006E
city: Nashik
country: India
facility: Tanvex Investigational Site 7001E
city: Pune
country: India
facility: Tanvex Investigational Site 7015E
city: Vijayawada
country: India
facility: Tanvex Investigational Site 7017E
city: Aguascalientes
country: Mexico
facility: Tanvex Investigational Site 2109E
city: Monterrey
country: Mexico
facility: Tanvex Investigational Site 2103E
city: Oaxaca
country: Mexico
facility: Tanvex Investigational Site 2106E
city: Tequisquiapan
country: Mexico
facility: Tanvex Investigational Site 2110E
city: Zapopan
country: Mexico
facility: Tanvex Investigational Site 2108E
city: Arequipa
country: Peru
facility: Tanvex Investigational Site 1101E
city: Arequipa
country: Peru
facility: Tanvex Investigational Site 1107E
city: Chiclayo
country: Peru
facility: Tanvex Investigational Site 1104E
city: Lima Cercado
country: Peru
facility: Tanvex Investigational Site 1112E
city: Lima
country: Peru
facility: Tanvex Investigational Site 1105E
city: San Borja
country: Peru
facility: Tanvex Investigational Site 1108E
city: San Isidro
country: Peru
facility: Tanvex Investigational Site 1102E
city: Surquillo
country: Peru
facility: Tanvex Investigational Site 1109E
city: Trujillo
country: Peru
facility: Tanvex Investigational Site 1103E
city: Cebu city
country: Philippines
facility: Tanvex Investigational Site 1211E
city: Davao City
country: Philippines
facility: Tanvex Investigational Site 1212E
city: Makati City
country: Philippines
facility: Tanvex Investigational Site 1214E
city: Quezon City
country: Philippines
facility: Tanvex Investigational Site 1209E
city: Quezon City
country: Philippines
facility: Tanvex Investigational Site 1213E
city: Santo Tomas
country: Philippines
facility: Tanvex Invesitgational Site 1210E
city: Sochi
country: Russian Federation
facility: Tanvex Investigational Site 1513E
state: Krasnodar Region
city: Arkhangelsk
country: Russian Federation
facility: Tanvex Investigational Site 1535E
city: Belgorod
country: Russian Federation
facility: Tanvex Investigational Site 1531E
city: Kaluga
country: Russian Federation
facility: Tanvex Investigational Site 1502E
city: Kislino
country: Russian Federation
facility: Tanvex Investigational Site 1505E
city: Krasnodar
country: Russian Federation
facility: Tanvex Investigational Site 1529E
city: Krasnoyarsk
country: Russian Federation
facility: Tanvex Investigational Site 1512E
city: Moscow
country: Russian Federation
facility: Tanvex Investigational Site 1530E
city: Moscow
country: Russian Federation
facility: Tanvex Investigational Site 1507E
city: Novosibirsk
country: Russian Federation
facility: Tanvex Investigational Site 1511E
city: Omsk
country: Russian Federation
facility: Tanvex Investigational Site 1503E
city: Omsk
country: Russian Federation
facility: Tanvex Investigational Site 1509E
city: Orenburg
country: Russian Federation
facility: Tanvex Investigational Site 1537E
city: Pesochnyy
country: Russian Federation
facility: Tanvex Investigational Site 1526E
city: Pushkin
country: Russian Federation
facility: Tanvex Investigational Site 1510E
city: Rostov-Na-Donu
country: Russian Federation
facility: Tanvex Investigational Site 1521E
city: Saint Petersburg
country: Russian Federation
facility: Tanvex Investigational Site 1516E
city: Saint Petersburg
country: Russian Federation
facility: Tanvex Investigational Site 1524E
city: Saint Petersburg
country: Russian Federation
facility: Tanvex Investigational Site 1525E
city: Saint Petersburg
country: Russian Federation
facility: Tanvex Investigational Site 1506E
city: Saint Petersburg
country: Russian Federation
facility: Tanvex Investigational Site 1501E
city: Sankt-peterburg
country: Russian Federation
facility: Tanvex Investigational Site 1523E
city: Saransk
country: Russian Federation
facility: Tanvex Investigational Site 1508E
city: Yaroslavl
country: Russian Federation
facility: Tanvex Investigational Site 1534E
city: Antonivka
country: Ukraine
facility: Tanvex Investigational Site 1820E
city: Chernihiv
country: Ukraine
facility: Tanvex Investigational Site 1803E
city: Chernihiv
country: Ukraine
facility: Tanvex Investigational Site 1808E
city: Chernivtsi
country: Ukraine
facility: Tanvex Investigational Site 1821E
city: Dnipro
country: Ukraine
facility: Tanvex Investigational Site 1824E
city: Kiev
country: Ukraine
facility: Tanvex Investigational Site 1811E
city: Kiev
country: Ukraine
facility: Tanvex Investigational Site 1802E
city: Kropyvnytskyi
country: Ukraine
facility: Tanvex Investigational Site 1819E
city: Kropyvnytskyi
country: Ukraine
facility: Tanvex Investigational Site 1814E
city: Kryvyi Rih
country: Ukraine
facility: Tanvex Investigational Site 1804E
city: Kyiv
country: Ukraine
facility: Tanvex Investigational Site 1815E
city: Kyiv
country: Ukraine
facility: Tanvex Investigational Site 1809E
city: Odesa
country: Ukraine
facility: Tanvex Investigational Site 1810E
city: Sumy
country: Ukraine
facility: Tanvex Investigational Site 1806E
city: Ternopil
country: Ukraine
facility: Tanvex Investigational Site 1822E
city: Vinnytsia
country: Ukraine
facility: Tanvex Investigational Site 1818E
city: Zaporizhzhya
country: Ukraine
facility: Tanvex Investigational Site 1813E
Study officials:
affiliation: Tanvex BioPharma USA, Inc.
name: Bonnie Mills, PhD
role: STUDY_DIRECTOR
References: