Trials / Completed
CompletedNCT04109391
Extension Study to Provide Adjuvant Treatment Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 338 (actual)
- Sponsor
- Tanvex BioPharma USA, Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2019-08-20
- Primary completion
- 2021-12-25
- Completion
- 2022-03-08
- First posted
- 2019-09-30
- Last updated
- 2022-10-26
- Results posted
- 2022-10-26
Locations
86 sites across 10 countries: Belarus, Chile, Georgia, Hungary, India, Mexico, Peru, Philippines, Russia, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04109391. Inclusion in this directory is not an endorsement.