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Evaluate Safety, Efficacy and Pharmacokinetics

2014-08-27 03:15:18 | BioPortfolio

Summary

The purpose of the study is to demonstrate equivalent pharmacokinetics (PK)

Description

Patients will receive CT-P6 or Herceptin.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Conditions

Metastatic Breast Cancer

Intervention

CT-P6, Herceptin, Paclitaxel

Location

Samsung Medical Center
Seoul
Korea, Republic of

Status

Recruiting

Source

Celltrion

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:18-0400

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Medical and Biotech [MESH] Definitions

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.

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

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A synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE. Goserelin is used in treatments of malignant NEOPLASMS of the prostate, uterine fibromas, and metastatic breast cancer.

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)

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