Extension Study to Provide Adjuvant Treatment Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04109391
• Other study ID #: TX05-03E
• Status: Completed
• Phase: Phase 3
• Start date: August 20, 2019
• Est. completion date: March 8, 2022

Study information

• Verified date: April 2022
• Source: Tanvex BioPharma USA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 338
• Est. completion date: March 8, 2022
• Est. primary completion date: December 25, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Early-stage Breast Cancer
• HER2-positive Breast Cancer
• Stage II Breast Cancer
• Stage IIIA Breast Cancer

Intervention

Biological:
• TX05 (trastuzumab)
Subjects will receive up to 13 cycles of adjuvant treatment.
• Herceptin (trastuzumab)
Subjects will receive up to 13 cycles of adjuvant treatment.

Locations

Country	Name	City	State
Belarus	Tanvex Investigational Site 1003E	Gomel
Belarus	Tanvex Investigational Site 1006E	Grodno
Belarus	Tanvex Investigational Site 1008E	Lesnoy
Belarus	Tanvex Investigational Site 1002E	Minsk
Belarus	Tanvex Investigational Site 1005E	Mogilev
Belarus	Tanvex Investigational Site 1001E	Vitebsk
Chile	Tanvex Investigational Site 4001E	Temuco
Chile	Tanvex Investigational Site 4002E	Vina del Mar
Georgia	Tanvex Investigational Site 5002E	Batumi
Georgia	Tanvex Investigational Site 5006E	Batumi
Georgia	Tanvex Investigational Site 5001E	Tbilisi
Georgia	Tanvex Investigational Site 5005E	Tbilisi
Georgia	Tanvex Investigational Site 5008E	Tbilisi
Georgia	Tanvex Investigational Site 5010E	Tbilisi
Hungary	Tanvex Investigational Site 6003E	Budapest
India	Tanvex Investigational Site 7033E	Ahmedabad
India	Tanvex Investigational Site 7019E	Bangalore
India	Tanvex Investigational Site 7022E	Belgaum
India	Tanvex Investigational Site 7036E	Hyderabad
India	Tanvex Investigational Site 7045E	Hyderabad
India	Tanvex Investigational Site 7006E	Kolkata
India	Tanvex Investigational Site 7001E	Nashik
India	Tanvex Investigational Site 7031E	Nashik	Maharashtra
India	Tanvex Investigational Site 7015E	Pune
India	Tanvex Investigational Site 7017E	Vijayawada
Mexico	Tanvex Investigational Site 2109E	Aguascalientes
Mexico	Tanvex Investigational Site 2103E	Monterrey
Mexico	Tanvex Investigational Site 2106E	Oaxaca
Mexico	Tanvex Investigational Site 2110E	Tequisquiapan
Mexico	Tanvex Investigational Site 2108E	Zapopan
Peru	Tanvex Investigational Site 1101E	Arequipa
Peru	Tanvex Investigational Site 1107E	Arequipa
Peru	Tanvex Investigational Site 1104E	Chiclayo
Peru	Tanvex Investigational Site 1105E	Lima
Peru	Tanvex Investigational Site 1112E	Lima Cercado
Peru	Tanvex Investigational Site 1108E	San Borja
Peru	Tanvex Investigational Site 1102E	San Isidro
Peru	Tanvex Investigational Site 1109E	Surquillo
Peru	Tanvex Investigational Site 1103E	Trujillo
Philippines	Tanvex Investigational Site 1211E	Cebu city
Philippines	Tanvex Investigational Site 1212E	Davao City
Philippines	Tanvex Investigational Site 1214E	Makati City
Philippines	Tanvex Investigational Site 1209E	Quezon City
Philippines	Tanvex Investigational Site 1213E	Quezon City
Philippines	Tanvex Invesitgational Site 1210E	Santo Tomas
Russian Federation	Tanvex Investigational Site 1535E	Arkhangelsk
Russian Federation	Tanvex Investigational Site 1531E	Belgorod
Russian Federation	Tanvex Investigational Site 1502E	Kaluga
Russian Federation	Tanvex Investigational Site 1505E	Kislino
Russian Federation	Tanvex Investigational Site 1529E	Krasnodar
Russian Federation	Tanvex Investigational Site 1512E	Krasnoyarsk
Russian Federation	Tanvex Investigational Site 1507E	Moscow
Russian Federation	Tanvex Investigational Site 1530E	Moscow
Russian Federation	Tanvex Investigational Site 1511E	Novosibirsk
Russian Federation	Tanvex Investigational Site 1503E	Omsk
Russian Federation	Tanvex Investigational Site 1509E	Omsk
Russian Federation	Tanvex Investigational Site 1537E	Orenburg
Russian Federation	Tanvex Investigational Site 1526E	Pesochnyy
Russian Federation	Tanvex Investigational Site 1510E	Pushkin
Russian Federation	Tanvex Investigational Site 1521E	Rostov-Na-Donu
Russian Federation	Tanvex Investigational Site 1501E	Saint Petersburg
Russian Federation	Tanvex Investigational Site 1506E	Saint Petersburg
Russian Federation	Tanvex Investigational Site 1516E	Saint Petersburg
Russian Federation	Tanvex Investigational Site 1524E	Saint Petersburg
Russian Federation	Tanvex Investigational Site 1525E	Saint Petersburg
Russian Federation	Tanvex Investigational Site 1523E	Sankt-peterburg
Russian Federation	Tanvex Investigational Site 1508E	Saransk
Russian Federation	Tanvex Investigational Site 1513E	Sochi	Krasnodar Region
Russian Federation	Tanvex Investigational Site 1534E	Yaroslavl
Ukraine	Tanvex Investigational Site 1820E	Antonivka
Ukraine	Tanvex Investigational Site 1803E	Chernihiv
Ukraine	Tanvex Investigational Site 1808E	Chernihiv
Ukraine	Tanvex Investigational Site 1821E	Chernivtsi
Ukraine	Tanvex Investigational Site 1824E	Dnipro
Ukraine	Tanvex Investigational Site 1802E	Kiev
Ukraine	Tanvex Investigational Site 1811E	Kiev
Ukraine	Tanvex Investigational Site 1814E	Kropyvnytskyi
Ukraine	Tanvex Investigational Site 1819E	Kropyvnytskyi
Ukraine	Tanvex Investigational Site 1804E	Kryvyi Rih
Ukraine	Tanvex Investigational Site 1809E	Kyiv
Ukraine	Tanvex Investigational Site 1815E	Kyiv
Ukraine	Tanvex Investigational Site 1810E	Odesa
Ukraine	Tanvex Investigational Site 1806E	Sumy
Ukraine	Tanvex Investigational Site 1822E	Ternopil
Ukraine	Tanvex Investigational Site 1818E	Vinnytsia
Ukraine	Tanvex Investigational Site 1813E	Zaporizhzhya

Sponsors (1)

Lead Sponsor	Collaborator
Tanvex BioPharma USA, Inc.

Countries where clinical trial is conducted

Belarus,  Chile,  Georgia,  Hungary,  India,  Mexico,  Peru,  Philippines,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity Assessments (ADA and Nab)	Samples for the evaluation of anti-drug antibodies (ADA), including neutralizing antibodies (Nab) were obtained before the administration of Cycle 1 (Week 0), Cycle 6 (Week 15), and the EOT/ET Visit. Only subjects with a positive ADA result were further tested for ADA cross-reactivity and Nab. Only subjects with a positive Nab result were further tested for Nab cross-reactivity.	Assessed from first infusion through end of treatment (Week 45) or Early Termination visit. Each cycle is 3 weeks.
Primary	Disease-Free Survival	DFS, defined as the time from randomization in the neoadjuvant study (Protocol TX05-03) to the documentation of a first failure, where a failure was the recurrence of breast cancer or a diagnosis of a second primary cancer.	Through study completion/end of treatment (Week 45).
Primary	Overall Survival	OS, defined as the time from randomization in the neoadjuvant study (Protocol TX05-03) until death from any cause.	Through study completion/end of treatment (Week 45).