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MVA-BN®-HER2 Vaccine in Locally Advanced & Advanced HER2+ Breast Cancer (Gene Transfer Protocol)

2014-07-24 14:00:44 | BioPortfolio

Summary

Primary Objectives:

To evaluate the safety of MVA-BN-HER2 in women with HER-2-positive breast cancer.

Secondary Objectives:

To evaluate the ability of MVA-BN-HER2 to generate humoral and cellular immune responses to HER-2, and to evaluate the duration of these responses.

Exploratory analysis comparing the ability of MVA-BN-HER2 to generate humoral and cellular immune responses to Her-2 in high risk stage III patients who have completed adjuvant chemotherapy and Trastuzumab and stage IV breast cancer patients who must receive ongoing therapy for metastatic disease.

Feasibility of completing 6 vaccines in this high risk patient population.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Breast Cancer

Intervention

MVA-BN-HER2 Vaccine

Location

Stanford University School of Medicine
Stanford
California
United States
94305

Status

Not yet recruiting

Source

Stanford University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:00:44-0400

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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.

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