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

October 4, 2022 updated by: Tanvex BioPharma USA, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

338

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
      • Gomel, Belarus, 246012
        • Tanvex Investigational Site 1003E
      • Grodno, Belarus, 230017
        • Tanvex Investigational Site 1006E
      • Lesnoy, Belarus, 223040
        • Tanvex Investigational Site 1008E
      • Minsk, Belarus, 220013
        • Tanvex Investigational Site 1002E
      • Mogilev, Belarus, 212018
        • Tanvex Investigational Site 1005E
      • Vitebsk, Belarus, 210603
        • Tanvex Investigational Site 1001E
  • Chile
      • Temuco, Chile, 2520598
        • Tanvex Investigational Site 4001E
      • Vina del Mar, Chile, 4810469
        • Tanvex Investigational Site 4002E
  • Georgia
      • Batumi, Georgia, 6000
        • Tanvex Investigational Site 5006E
      • Batumi, Georgia, 6010
        • Tanvex Investigational Site 5002E
      • Tbilisi, Georgia, 0159
        • Tanvex Investigational Site 5001E
      • Tbilisi, Georgia, 0159
        • Tanvex Investigational Site 5005E
      • Tbilisi, Georgia, 0186
        • Tanvex Investigational Site 5010E
      • Tbilisi, Georgia, 112
        • Tanvex Investigational Site 5008E
  • Hungary
      • Budapest, Hungary
        • Tanvex Investigational Site 6003E
  • India
      • Ahmedabad, India, 380016
        • Tanvex Investigational Site 7033E
      • Bangalore, India, 560027
        • Tanvex Investigational Site 7019E
      • Belgaum, India, 590010
        • Tanvex Investigational Site 7022E
      • Hyderabad, India, 500004
        • Tanvex Investigational Site 7045E
      • Hyderabad, India, 500034
        • Tanvex Investigational Site 7036E
      • Kolkata, India, 700099
        • Tanvex Investigational Site 7006E
      • Nashik, India, 422002
        • Tanvex Investigational Site 7001E
      • Pune, India, 411001
        • Tanvex Investigational Site 7015E
      • Vijayawada, India, 520002
        • Tanvex Investigational Site 7017E
    • Maharashtra
      • Nashik, Maharashtra, India, 422002
        • Tanvex Investigational Site 7031E
  • Mexico
      • Aguascalientes, Mexico, 20234
        • Tanvex Investigational Site 2109E
      • Monterrey, Mexico, 64000
        • Tanvex Investigational Site 2103E
      • Oaxaca, Mexico, 68000
        • Tanvex Investigational Site 2106E
      • Tequisquiapan, Mexico, 76750
        • Tanvex Investigational Site 2110E
      • Zapopan, Mexico, 45030
        • Tanvex Investigational Site 2108E
  • Peru
      • Arequipa, Peru, 04001
        • Tanvex Investigational Site 1101E
      • Arequipa, Peru, 04001
        • Tanvex Investigational Site 1107E
      • Chiclayo, Peru, 14001
        • Tanvex Investigational Site 1104E
      • Lima, Peru, 15036
        • Tanvex Investigational Site 1105E
      • Lima Cercado, Peru, 15082
        • Tanvex Investigational Site 1112E
      • San Borja, Peru, 41
        • Tanvex Investigational Site 1108E
      • San Isidro, Peru, 15073
        • Tanvex Investigational Site 1102E
      • Surquillo, Peru, 15038
        • Tanvex Investigational Site 1109E
      • Trujillo, Peru, 13001
        • Tanvex Investigational Site 1103E
  • Philippines
      • Cebu city, Philippines, 6000
        • Tanvex Investigational Site 1211E
      • Davao City, Philippines, 8000
        • Tanvex Investigational Site 1212E
      • Makati City, Philippines, 1229
        • Tanvex Investigational Site 1214E
      • Quezon City, Philippines, 1101
        • Tanvex Investigational Site 1209E
      • Quezon City, Philippines, 1102
        • Tanvex Investigational Site 1213E
      • Santo Tomas, Philippines, 4234
        • Tanvex Invesitgational Site 1210E
  • Russian Federation
      • Arkhangelsk, Russian Federation, 163045
        • Tanvex Investigational Site 1535E
      • Belgorod, Russian Federation, 308010
        • Tanvex Investigational Site 1531E
      • Kaluga, Russian Federation
        • Tanvex Investigational Site 1502E
      • Kislino, Russian Federation, 305524
        • Tanvex Investigational Site 1505E
      • Krasnodar, Russian Federation, 350040
        • Tanvex Investigational Site 1529E
      • Krasnoyarsk, Russian Federation, 660133
        • Tanvex Investigational Site 1512E
      • Moscow, Russian Federation, 121467
        • Tanvex Investigational Site 1530E
      • Moscow, Russian Federation
        • Tanvex Investigational Site 1507E
      • Novosibirsk, Russian Federation, 630099
        • Tanvex Investigational Site 1511E
      • Omsk, Russian Federation, 644013
        • Tanvex Investigational Site 1503E
      • Omsk, Russian Federation, 644013
        • Tanvex Investigational Site 1509E
      • Orenburg, Russian Federation, 460021
        • Tanvex Investigational Site 1537E
      • Pesochnyy, Russian Federation, 197758
        • Tanvex Investigational Site 1526E
      • Pushkin, Russian Federation, 196603
        • Tanvex Investigational Site 1510E
      • Rostov-Na-Donu, Russian Federation, 344037
        • Tanvex Investigational Site 1521E
      • Saint Petersburg, Russian Federation, 191015
        • Tanvex Investigational Site 1516E
      • Saint Petersburg, Russian Federation, 191104
        • Tanvex Investigational Site 1524E
      • Saint Petersburg, Russian Federation, 196247
        • Tanvex Investigational Site 1525E
      • Saint Petersburg, Russian Federation, 197758
        • Tanvex Investigational Site 1506E
      • Saint Petersburg, Russian Federation
        • Tanvex Investigational Site 1501E
      • Sankt-peterburg, Russian Federation, 191104
        • Tanvex Investigational Site 1523E
      • Saransk, Russian Federation, 430032
        • Tanvex Investigational Site 1508E
      • Yaroslavl, Russian Federation, 150054
        • Tanvex Investigational Site 1534E
    • Krasnodar Region
      • Sochi, Krasnodar Region, Russian Federation, 354057
        • Tanvex Investigational Site 1513E
  • Ukraine
      • Antonivka, Ukraine, 73000
        • Tanvex Investigational Site 1820E
      • Chernihiv, Ukraine, 14029
        • Tanvex Investigational Site 1803E
      • Chernihiv, Ukraine, 14029
        • Tanvex Investigational Site 1808E
      • Chernivtsi, Ukraine, 58013
        • Tanvex Investigational Site 1821E
      • Dnipro, Ukraine, 49600
        • Tanvex Investigational Site 1824E
      • Kiev, Ukraine, 03115
        • Tanvex Investigational Site 1811E
      • Kiev, Ukraine, 04107
        • Tanvex Investigational Site 1802E
      • Kropyvnytskyi, Ukraine, 25006
        • Tanvex Investigational Site 1819E
      • Kropyvnytskyi, Ukraine, 25011
        • Tanvex Investigational Site 1814E
      • Kryvyi Rih, Ukraine, 50048
        • Tanvex Investigational Site 1804E
      • Kyiv, Ukraine, 03022
        • Tanvex Investigational Site 1815E
      • Kyiv, Ukraine, 03126
        • Tanvex Investigational Site 1809E
      • Odesa, Ukraine, 65055
        • Tanvex Investigational Site 1810E
      • Sumy, Ukraine, 40022
        • Tanvex Investigational Site 1806E
      • Ternopil, Ukraine, 46023
        • Tanvex Investigational Site 1822E
      • Vinnytsia, Ukraine, 21029
        • Tanvex Investigational Site 1818E
      • Zaporizhzhya, Ukraine, 69059
        • Tanvex Investigational Site 1813E

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Product (TX05)

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)
Subjects will receive up to 13 cycles of adjuvant treatment.
Active Comparator: Reference Therapy (Herceptin)

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)
Subjects will receive up to 13 cycles of adjuvant treatment.
Experimental: Test Product (Herceptin/TX05 Transition)

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)
Subjects will receive up to 13 cycles of adjuvant treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity Assessments (ADA and Nab)
Time Frame: 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.
Assessed from first infusion through end of treatment (Week 45) or Early Termination visit. Each cycle is 3 weeks.
Disease-Free Survival
Time Frame: 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.
Through study completion/end of treatment (Week 45).
Overall Survival
Time Frame: 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.
Through study completion/end of treatment (Week 45).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanvex BioPharma USA, Inc.

Investigators

  • Study Director: Bonnie Mills, PhD, Tanvex BioPharma USA, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2019

Primary Completion (Actual)

December 25, 2021

Study Completion (Actual)

March 8, 2022

Study Registration Dates

First Submitted

September 20, 2019

First Submitted That Met QC Criteria

September 26, 2019

First Posted (Actual)

September 30, 2019

Study Record Updates

Last Update Posted (Actual)

October 26, 2022

Last Update Submitted That Met QC Criteria

October 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TX05-03E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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