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

2019-10-04 08:31:38 | BioPortfolio


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 Design


HER2-positive Breast Cancer


TX05 (trastuzumab), Herceptin (trastuzumab)


Tanvex Investigational Site


Enrolling by invitation


Tanvex BioPharma USA, Inc.

Results (where available)

View Results


Published on BioPortfolio: 2019-10-04T08:31:38-0400

Clinical Trials [5834 Associated Clinical Trials listed on BioPortfolio]

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

This is a Phase III, double-blind, randomized, multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of TX05 (trastuzumab) with Herceptin® in subjects wi...

A Study of MM-111 in Combination With (Herceptin) Trastuzumab in Patients With Advanced Her2 Positive Breast Cancer

This is an open-label Phase 1-2 trial of MM-111 in combination with Herceptin (trastuzumab).

IRS Proteins and Trastuzumab Resistance

Significant progress has been made in the treatment of women with Her2 positive breast cancer who are treated with trastuzumab, a humanized monoclonal antibody that inhibits Her2. Despite...

A Study of Subcutaneous At Home Administration of Herceptin (Trastuzumab) in Patients With HER2-Positive Early Breast Cancer

This single arm, multicenter study will evaluate the safety of assisted subcutan eous administration of Herceptin (trastuzumab) in patients with HER2-positive ea rly breast cancer. Patient...

A Dose Finding Study of Subcutaneous Herceptin (Trastuzumab) in Healthy Male Volunteers and HER2 Positive Female Patients

This 2 part study will select the subcutaneous(sc) dose of Herceptin which resul ts in comparable exposure to intravenous(iv) Herceptin in healthy male volunteer s and in HER2 positive fem...

PubMed Articles [19124 Associated PubMed Articles listed on BioPortfolio]

Long-term survival in HER2-positive metastatic breast cancer treated with first-line trastuzumab: results from the french real-life curie database.

Outcome of HER2-positive metastatic breast cancer (MBC) patients has improved since the use of trastuzumab. However, most HER2-positive MBC patients will progress within 1 year of trastuzumab-based t...

Radiological complete remission in HER2-positive metastatic breast cancer patients: what to do with trastuzumab?

Patients with HER2-positive metastatic breast cancer (MBC) treated with trastuzumab may experience durable tumor response for many years. It is unknown if patients with durable radiological complete r...

Cullin7 Enhances Resistance to Trastuzumab Therapy in Her2 Positive Breast Cancer via Degrading IRS-1 and Downregulating IGFBP-3 to Activate the PI3K/AKT Pathway.

Patients with Her2-positive breast cancer exhibit de novo resistance or develop acquired resistance in less than one year after Her2 targeting treatment, but the mechanism is not fully elucidated. Com...

Efficacy and safety of HER2 inhibitors in combination with or without pertuzumab for HER2-positive breast cancer: a systematic review and meta-analysis.

Although the dual anti-HER2 therapy, namely, pertuzumab plus trastuzumab and docetaxel, has shown promising results in HER2+ breast cancer patients, whether the dose, efficacy and safety of this treat...

Deciphering trastuzumab resistance in residual tumor according to HER2 status after neoadjuvant trastuzumab containing regimen in HER2 positive breast cancer patients might help to choose further adjuvant anti-HER2 treatment.

Medical and Biotech [MESH] Definitions

A humanized monoclonal antibody against the ERBB-2 RECEPTOR (HER2). As an ANTINEOPLASTIC AGENT, it is used to treat BREAST CANCER where HER2 is overexpressed.

Abnormal accumulation of lymph in the arm, shoulder and breast area associated with surgical or radiation breast cancer treatments (e.g., MASTECTOMY).

Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.

A infiltrating (invasive) breast cancer, relatively uncommon, accounting for only 5%-10% of breast tumors in most series. It is often an area of ill-defined thickening in the breast, in contrast to the dominant lump characteristic of ductal carcinoma. It is typically composed of small cells in a linear arrangement with a tendency to grow around ducts and lobules. There is likelihood of axillary nodal involvement with metastasis to meningeal and serosal surfaces. (DeVita Jr et al., Cancer: Principles & Practice of Oncology, 3d ed, p1205)

A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.

More From BioPortfolio on "Extension Study to Provide Adjuvant Treatment Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03"

Quick Search

Relevant Topic

Breast Cancer
Track and monitor developments in breast cancer research and commercial development.  Follow the tabs above to read the latest global news, research, clinical trials on breast cancer and follow companies active in the development of breast cancer tr...

Searches Linking to this Trial