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

NCT04109391 | Completed Phase 3 Results FDA Drug

• 1 other identifier: TX05-03E
• Study Type: interventional
• Target: 338
• Locations: 10 countries
• Sites: 86

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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.

• 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).

• 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).

Study Arms (3)

Test Product (TX05)

EXPERIMENTAL

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.

Biological: TX05 (trastuzumab)

Reference Therapy (Herceptin)

ACTIVE COMPARATOR

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.

Biological: Herceptin (trastuzumab)

Test Product (Herceptin/TX05 Transition)

EXPERIMENTAL

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.

Biological: TX05 (trastuzumab)

Interventions

TX05 (trastuzumab) BIOLOGICAL

Subjects will receive up to 13 cycles of adjuvant treatment.

Test Product (Herceptin/TX05 Transition); Test Product (TX05)

Herceptin (trastuzumab) BIOLOGICAL

Subjects will receive up to 13 cycles of adjuvant treatment.

Reference Therapy (Herceptin)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanvex BioPharma USA, Inc.: lead

Study Sites (86)

Tanvex Investigational Site 1006E

Grodno, 230017, Belarus

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Tanvex Investigational Site 1003E

Homyel, 246012, Belarus

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Tanvex Investigational Site 1008E

Lesnoy, 223040, Belarus

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Tanvex Investigational Site 1002E

Minsk, 220013, Belarus

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Tanvex Investigational Site 1005E

Mogilev, 212018, Belarus

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Tanvex Investigational Site 1001E

Vitebsk, 210603, Belarus

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Tanvex Investigational Site 4001E

Temuco, 2520598, Chile

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Tanvex Investigational Site 4002E

Viña del Mar, 4810469, Chile

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Tanvex Investigational Site 5006E

Batumi, 6000, Georgia

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Tanvex Investigational Site 5002E

Batumi, 6010, Georgia

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Tanvex Investigational Site 5001E

Tbilisi, 0159, Georgia

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Tanvex Investigational Site 5005E

Tbilisi, 0159, Georgia

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Tanvex Investigational Site 5010E

Tbilisi, 0186, Georgia

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Tanvex Investigational Site 5008E

Tbilisi, 112, Georgia

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Tanvex Investigational Site 6003E

Budapest, Hungary

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Tanvex Investigational Site 7031E

Nashik, Maharashtra, 422002, India

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Tanvex Investigational Site 7033E

Ahmedabad, 380016, India

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Tanvex Investigational Site 7019E

Bangalore, 560027, India

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Tanvex Investigational Site 7022E

Belagavi, 590010, India

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Tanvex Investigational Site 7045E

Hyderabad, 500004, India

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Tanvex Investigational Site 7036E

Hyderabad, 500034, India

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Tanvex Investigational Site 7006E

Kolkata, 700099, India

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Tanvex Investigational Site 7001E

Nashik, 422002, India

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Tanvex Investigational Site 7015E

Pune, 411001, India

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Tanvex Investigational Site 7017E

Vijayawada, 520002, India

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Tanvex Investigational Site 2109E

Aguascalientes, 20234, Mexico

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Tanvex Investigational Site 2103E

Monterrey, 64000, Mexico

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Tanvex Investigational Site 2106E

Oaxaca City, 68000, Mexico

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Tanvex Investigational Site 2110E

Tequisquiapan, 76750, Mexico

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Tanvex Investigational Site 2108E

Zapopan, 45030, Mexico

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Tanvex Investigational Site 1101E

Arequipa, 04001, Peru

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Tanvex Investigational Site 1107E

Arequipa, 04001, Peru

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Tanvex Investigational Site 1104E

Chiclayo, 14001, Peru

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Tanvex Investigational Site 1105E

Lima, 15036, Peru

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Tanvex Investigational Site 1112E

Lima Cercado, 15082, Peru

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Tanvex Investigational Site 1108E

San Borja, 41, Peru

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Tanvex Investigational Site 1102E

San Isidro, 15073, Peru

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Tanvex Investigational Site 1109E

Surquillo, 15038, Peru

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Tanvex Investigational Site 1103E

Trujillo, 13001, Peru

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Tanvex Investigational Site 1211E

Cebu City, 6000, Philippines

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Tanvex Investigational Site 1212E

Davao City, 8000, Philippines

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Tanvex Investigational Site 1214E

Makati City, 1229, Philippines

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Tanvex Investigational Site 1209E

Quezon City, 1101, Philippines

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Tanvex Investigational Site 1213E

Quezon City, 1102, Philippines

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Tanvex Invesitgational Site 1210E

Santo Tomas, 4234, Philippines

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Tanvex Investigational Site 1513E

Sochi, Krasnodarskiy Kray, 354057, Russia

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Tanvex Investigational Site 1535E

Arkhangelsk, 163045, Russia

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Tanvex Investigational Site 1531E

Belgorod, 308010, Russia

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Tanvex Investigational Site 1502E

Kaluga, Russia

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Tanvex Investigational Site 1505E

Kislino, 305524, Russia

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Tanvex Investigational Site 1529E

Krasnodar, 350040, Russia

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Tanvex Investigational Site 1512E

Krasnoyarsk, 660133, Russia

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Tanvex Investigational Site 1530E

Moscow, 121467, Russia

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Tanvex Investigational Site 1507E

Moscow, Russia

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Tanvex Investigational Site 1511E

Novosibirsk, 630099, Russia

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Tanvex Investigational Site 1503E

Omsk, 644013, Russia

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Tanvex Investigational Site 1509E

Omsk, 644013, Russia

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Tanvex Investigational Site 1537E

Orenburg, 460021, Russia

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Tanvex Investigational Site 1526E

Pesochnyy, 197758, Russia

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Tanvex Investigational Site 1510E

Pushkin, 196603, Russia

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Tanvex Investigational Site 1521E

Rostov-on-Don, 344037, Russia

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Tanvex Investigational Site 1516E

Saint Petersburg, 191015, Russia

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Tanvex Investigational Site 1523E

Saint Petersburg, 191104, Russia

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Tanvex Investigational Site 1524E

Saint Petersburg, 191104, Russia

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Tanvex Investigational Site 1525E

Saint Petersburg, 196247, Russia

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Tanvex Investigational Site 1506E

Saint Petersburg, 197758, Russia

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Tanvex Investigational Site 1501E

Saint Petersburg, Russia

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Tanvex Investigational Site 1508E

Saransk, 430032, Russia

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Tanvex Investigational Site 1534E

Yaroslavl, 150054, Russia

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Tanvex Investigational Site 1820E

Antonivka, 73000, Ukraine

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Tanvex Investigational Site 1803E

Chernihiv, 14029, Ukraine

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Tanvex Investigational Site 1808E

Chernihiv, 14029, Ukraine

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Tanvex Investigational Site 1821E

Chernivtsi, 58013, Ukraine

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Tanvex Investigational Site 1824E

Dnipro, 49600, Ukraine

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Tanvex Investigational Site 1811E

Kiev, 03115, Ukraine

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Tanvex Investigational Site 1802E

Kiev, 04107, Ukraine

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Tanvex Investigational Site 1819E

Kropyvnytskyi, 25006, Ukraine

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Tanvex Investigational Site 1814E

Kropyvnytskyi, 25011, Ukraine

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Tanvex Investigational Site 1804E

Kryvyi Rih, 50048, Ukraine

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Tanvex Investigational Site 1815E

Kyiv, 03022, Ukraine

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Tanvex Investigational Site 1809E

Kyiv, 03126, Ukraine

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Tanvex Investigational Site 1810E

Odesa, 65055, Ukraine

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Tanvex Investigational Site 1806E

Sumy, 40022, Ukraine

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Tanvex Investigational Site 1822E

Ternopil, 46023, Ukraine

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Tanvex Investigational Site 1818E

Vinnytsia, 21029, Ukraine

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Tanvex Investigational Site 1813E

Zaporizhzhya, 69059, Ukraine

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MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Tanvex

jennifer.lai@tanvex.com

19494838507

Study Officials

• Bonnie Mills, PhD

  Tanvex BioPharma USA, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 30, 2019
• Study Start: August 20, 2019
• Primary Completion: December 25, 2021
• Study Completion: March 8, 2022
• Last Updated: October 26, 2022
• Results First Posted: October 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

GE (6); ME (5); CL (2); HU (1); RU (24); PH (6); IN (10); UA (17); PE (9); BE (6)