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A Study of Pertuzumab in Combination With Herceptin (Trastuzumab) and A Taxane in First-Line Treatment in Patients With HER2-Positive Advanced Breast Cancer (PERUSE)

2014-09-25 15:08:23 | BioPortfolio

Summary

This multicenter, open-label, single-arm study will evaluate the safety and tole rability of pertuzumab in combination with Herceptin (trastuzumab) and a taxane in first-line treatment in patients with metastatic or locally recurrent HER2-po sitive breast cancer. Patients will receive pertuzumab 840 mg intravenously (iv) and Herceptin 8 mg/kg iv plus a taxane on Day 1 of Cycle 1, followed by pertuzu mab 420 mg iv and Herceptin 6 mg/kg iv plus a taxane on Day 1 of each subsequent 3-week cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Study Design

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

Conditions

Breast Cancer

Intervention

pertuzumab, taxane, trastuzumab [Herceptin]

Location

Algiers
Australian Capital Territory
Algeria
16000

Status

Recruiting

Source

Hoffmann-La Roche

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-09-25T15:08:23-0400

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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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