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Trial record 1 of 2 for:    tanvex
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Extension Study to Provide Adjuvant Treatment Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04109391
Recruitment Status : Completed
First Posted : September 30, 2019
Results First Posted : October 26, 2022
Last Update Posted : October 26, 2022
Sponsor:
Information provided by (Responsible Party):
Tanvex BioPharma USA, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
HER2-positive Breast Cancer Early-stage Breast Cancer Breast Cancer Breast Neoplasms Stage II Breast Cancer Stage IIIA Breast Cancer Biological: TX05 (trastuzumab) Biological: Herceptin (trastuzumab) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 338 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : August 20, 2019
Actual Primary Completion Date : December 25, 2021
Actual Study Completion Date : March 8, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Trastuzumab

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04109391


Locations
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Sponsors and Collaborators
Tanvex BioPharma USA, Inc.
Investigators
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Study Director: Bonnie Mills, PhD Tanvex BioPharma USA, Inc.
  Study Documents (Full-Text)

Documents provided by Tanvex BioPharma USA, Inc.:
Study Protocol  [PDF] December 13, 2018
Statistical Analysis Plan  [PDF] March 7, 2022

More Information
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Responsible Party: Tanvex BioPharma USA, Inc.
ClinicalTrials.gov Identifier: NCT04109391    
Other Study ID Numbers: TX05-03E
First Posted: September 30, 2019    Key Record Dates
Results First Posted: October 26, 2022
Last Update Posted: October 26, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents