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

NCT04109391 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 338

Last updated 2022-10-26

Study results available
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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

Interventions

BIOLOGICAL

TX05 (trastuzumab)

Subjects will receive up to 13 cycles of adjuvant treatment.

BIOLOGICAL

Herceptin (trastuzumab)

Subjects will receive up to 13 cycles of adjuvant treatment.

Sponsors & Collaborators

  • Tanvex BioPharma USA, Inc.

    lead INDUSTRY

Principal Investigators

  • Bonnie Mills, PhD · Tanvex BioPharma USA, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-20
Primary Completion
2021-12-25
Completion
2022-03-08
FDA Drug
Yes

Countries

  • Belarus
  • Chile
  • Georgia
  • Hungary
  • India
  • Mexico
  • Peru
  • Philippines
  • Russia
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04109391 on ClinicalTrials.gov