Completed PHASE3 INTERVENTIONAL 2-arm NCT03556358

Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer

A Randomized, Double-blind, Parallel Group, Phase III Trial to Compare the Efficacy, Safety, and Immunogenicity of TX05 With Herceptin® in Subjects With HER2 Positive Early Breast Cancer

Sponsor: Tanvex BioPharma USA, Inc.

Conditions Breast Cancer Breast Neoplasms HER2-positive Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer

Interventions Cyclophosphamide Epirubicin Herceptin® Paclitaxel TX05 (trastuzumab)

Updated 24 times since 2018 Last updated: Jan 7, 2022 Started: Jun 28, 2018 Primary completion: Nov 27, 2020 Completion: Feb 4, 2021

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03556358, this PHASE3 trial focuses on Breast Cancer and Breast Neoplasms and remains completed. Sponsored by Tanvex BioPharma USA, Inc., it has been updated 24 times since 2018, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

Change History

24 versions recorded

Mar 2026 — Present [monthly]

Completed PHASE3
Feb 2026 — Mar 2026 [monthly]

Completed PHASE3
Dec 2025 — Feb 2026 [monthly]

Completed PHASE3
Oct 2025 — Dec 2025 [monthly]

Completed PHASE3
Sep 2025 — Oct 2025 [monthly]

Completed PHASE3

▶ Show 19 earlier versions

Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Feb 2022 — Jul 2024 [monthly]

Completed PHASE3
May 2021 — Feb 2022 [monthly]

Completed PHASE3

Status: Active Not Recruiting → Completed
Mar 2021 — May 2021 [monthly]

Active Not Recruiting PHASE3
Jan 2021 — Mar 2021 [monthly]

Active Not Recruiting PHASE3
Jun 2020 — Jan 2021 [monthly]

Active Not Recruiting PHASE3

Status: Recruiting → Active Not Recruiting
Apr 2020 — Jun 2020 [monthly]

Recruiting PHASE3
Feb 2020 — Apr 2020 [monthly]

Recruiting PHASE3
Jan 2020 — Feb 2020 [monthly]

Recruiting PHASE3
Dec 2019 — Jan 2020 [monthly]

Recruiting PHASE3
Nov 2019 — Dec 2019 [monthly]

Recruiting PHASE3
May 2019 — Nov 2019 [monthly]

Recruiting PHASE3
Mar 2019 — May 2019 [monthly]

Recruiting PHASE3
Feb 2019 — Mar 2019 [monthly]

Recruiting PHASE3
Dec 2018 — Feb 2019 [monthly]

Recruiting PHASE3
Nov 2018 — Dec 2018 [monthly]

Recruiting PHASE3
Aug 2018 — Nov 2018 [monthly]

Recruiting PHASE3
Jul 2018 — Aug 2018 [monthly]

Recruiting PHASE3

First recorded

Jun 2018

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Tanvex BioPharma USA, Inc.

Data source: Tanvex BioPharma USA, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aguascalientes, Mexico , Ahmedabad, India , Arequipa, Peru , Arkhangelsk, Russia , Babruysk, Belarus , Bacolod City, Philippines , Bangalore, India , Batumi, Georgia , Belagavi, India , Belgorod, Russia and 90 more locations