Extension Study to Provide Adjuvant Treatment Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03
- Conditions
- Breast NeoplasmsEarly-stage Breast CancerBreast CancerHER2-positive Breast CancerStage II Breast CancerStage IIIA Breast Cancer
- Interventions
- Biological: TX05 (trastuzumab)Biological: Herceptin (trastuzumab)
- Registration Number
- NCT04109391
- Lead Sponsor
- Tanvex BioPharma USA, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 338
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test Product (Herceptin/TX05 Transition) TX05 (trastuzumab) IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment. These subjects received Herceptin on the TX05-03 study and were randomized to receive TX05 in this extension study. Reference Therapy (Herceptin) Herceptin (trastuzumab) IV trastuzumab (Herceptin) TX05 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles Herceptin (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment. These subjects received Herceptin on the TX05-03 study and were randomized to receive Herceptin in this extension study. Test Product (TX05) TX05 (trastuzumab) IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment. These subjects received TX05 on the TX05-03 study and continued to receive TX05 in this extension study.
- Primary Outcome Measures
Name Time Method Immunogenicity Assessments (ADA and Nab) Assessed from first infusion through end of treatment (Week 45) or Early Termination visit. Each cycle is 3 weeks. 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.
Disease-Free Survival Through study completion/end of treatment (Week 45). 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.
Overall Survival Through study completion/end of treatment (Week 45). OS, defined as the time from randomization in the neoadjuvant study (Protocol TX05-03) until death from any cause.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (86)
Tanvex Investigational Site 1002E
🇧🇾Minsk, Belarus
Tanvex Investigational Site 1005E
🇧🇾Mogilev, Belarus
Tanvex Investigational Site 5001E
🇬🇪Tbilisi, Georgia
Tanvex Investigational Site 1530E
🇷🇺Moscow, Russian Federation
Tanvex Investigational Site 1213E
🇵🇭Quezon City, Philippines
Tanvex Investigational Site 1512E
🇷🇺Krasnoyarsk, Russian Federation
Tanvex Investigational Site 1510E
🇷🇺Pushkin, Russian Federation
Tanvex Investigational Site 1521E
🇷🇺Rostov-Na-Donu, Russian Federation
Tanvex Investigational Site 1506E
🇷🇺Saint Petersburg, Russian Federation
Tanvex Investigational Site 1534E
🇷🇺Yaroslavl, Russian Federation
Tanvex Investigational Site 4001E
🇨🇱Temuco, Chile
Tanvex Investigational Site 1112E
🇵🇪Lima Cercado, Peru
Tanvex Investigational Site 1103E
🇵🇪Trujillo, Peru
Tanvex Investigational Site 1211E
🇵🇭Cebu city, Philippines
Tanvex Investigational Site 4002E
🇨🇱Vina del Mar, Chile
Tanvex Investigational Site 5006E
🇬🇪Batumi, Georgia
Tanvex Investigational Site 7036E
🇮🇳Hyderabad, India
Tanvex Investigational Site 2110E
🇲🇽Tequisquiapan, Mexico
Tanvex Investigational Site 1212E
🇵🇭Davao City, Philippines
Tanvex Investigational Site 1214E
🇵🇭Makati City, Philippines
Tanvex Investigational Site 1209E
🇵🇭Quezon City, Philippines
Tanvex Investigational Site 1509E
🇷🇺Omsk, Russian Federation
Tanvex Investigational Site 1824E
🇺🇦Dnipro, Ukraine
Tanvex Investigational Site 1810E
🇺🇦Odesa, Ukraine
Tanvex Investigational Site 1806E
🇺🇦Sumy, Ukraine
Tanvex Investigational Site 1803E
🇺🇦Chernihiv, Ukraine
Tanvex Investigational Site 1822E
🇺🇦Ternopil, Ukraine
Tanvex Investigational Site 1815E
🇺🇦Kyiv, Ukraine
Tanvex Investigational Site 7033E
🇮🇳Ahmedabad, India
Tanvex Investigational Site 7045E
🇮🇳Hyderabad, India
Tanvex Investigational Site 7006E
🇮🇳Kolkata, India
Tanvex Investigational Site 5002E
🇬🇪Batumi, Georgia
Tanvex Investigational Site 6003E
🇭🇺Budapest, Hungary
Tanvex Investigational Site 5010E
🇬🇪Tbilisi, Georgia
Tanvex Investigational Site 5008E
🇬🇪Tbilisi, Georgia
Tanvex Investigational Site 7022E
🇮🇳Belgaum, India
Tanvex Investigational Site 7015E
🇮🇳Pune, India
Tanvex Investigational Site 2109E
🇲🇽Aguascalientes, Mexico
Tanvex Investigational Site 7031E
🇮🇳Nashik, Maharashtra, India
Tanvex Investigational Site 5005E
🇬🇪Tbilisi, Georgia
Tanvex Investigational Site 7019E
🇮🇳Bangalore, India
Tanvex Investigational Site 7017E
🇮🇳Vijayawada, India
Tanvex Investigational Site 2103E
🇲🇽Monterrey, Mexico
Tanvex Investigational Site 2106E
🇲🇽Oaxaca, Mexico
Tanvex Investigational Site 1104E
🇵🇪Chiclayo, Peru
Tanvex Investigational Site 1531E
🇷🇺Belgorod, Russian Federation
Tanvex Investigational Site 1524E
🇷🇺Saint Petersburg, Russian Federation
Tanvex Investigational Site 1523E
🇷🇺Sankt-peterburg, Russian Federation
Tanvex Investigational Site 1820E
🇺🇦Antonivka, Ukraine
Tanvex Investigational Site 1804E
🇺🇦Kryvyi Rih, Ukraine
Tanvex Investigational Site 7001E
🇮🇳Nashik, India
Tanvex Investigational Site 1102E
🇵🇪San Isidro, Peru
Tanvex Investigational Site 2108E
🇲🇽Zapopan, Mexico
Tanvex Investigational Site 1107E
🇵🇪Arequipa, Peru
Tanvex Investigational Site 1105E
🇵🇪Lima, Peru
Tanvex Investigational Site 1108E
🇵🇪San Borja, Peru
Tanvex Investigational Site 1101E
🇵🇪Arequipa, Peru
Tanvex Investigational Site 1109E
🇵🇪Surquillo, Peru
Tanvex Investigational Site 1526E
🇷🇺Pesochnyy, Russian Federation
Tanvex Investigational Site 1516E
🇷🇺Saint Petersburg, Russian Federation
Tanvex Investigational Site 1508E
🇷🇺Saransk, Russian Federation
Tanvex Investigational Site 1819E
🇺🇦Kropyvnytskyi, Ukraine
Tanvex Investigational Site 1814E
🇺🇦Kropyvnytskyi, Ukraine
Tanvex Investigational Site 1003E
🇧🇾Gomel, Belarus
Tanvex Investigational Site 1006E
🇧🇾Grodno, Belarus
Tanvex Investigational Site 1008E
🇧🇾Lesnoy, Belarus
Tanvex Investigational Site 1001E
🇧🇾Vitebsk, Belarus
Tanvex Investigational Site 1537E
🇷🇺Orenburg, Russian Federation
Tanvex Investigational Site 1507E
🇷🇺Moscow, Russian Federation
Tanvex Investigational Site 1525E
🇷🇺Saint Petersburg, Russian Federation
Tanvex Investigational Site 1501E
🇷🇺Saint Petersburg, Russian Federation
Tanvex Investigational Site 1809E
🇺🇦Kyiv, Ukraine
Tanvex Investigational Site 1813E
🇺🇦Zaporizhzhya, Ukraine
Tanvex Invesitgational Site 1210E
🇵🇭Santo Tomas, Philippines
Tanvex Investigational Site 1535E
🇷🇺Arkhangelsk, Russian Federation
Tanvex Investigational Site 1503E
🇷🇺Omsk, Russian Federation
Tanvex Investigational Site 1808E
🇺🇦Chernihiv, Ukraine
Tanvex Investigational Site 1821E
🇺🇦Chernivtsi, Ukraine
Tanvex Investigational Site 1811E
🇺🇦Kiev, Ukraine
Tanvex Investigational Site 1802E
🇺🇦Kiev, Ukraine
Tanvex Investigational Site 1513E
🇷🇺Sochi, Krasnodar Region, 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 1511E
🇷🇺Novosibirsk, Russian Federation
Tanvex Investigational Site 1818E
🇺🇦Vinnytsia, Ukraine