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A Study to Assess Xeloda (Capecitabine) in Patients With Locally Advanced or Metastatic Breast Cancer

2014-08-27 03:54:33 | BioPortfolio

Summary

This 2 arm study will compare the efficacy and safety of label dose Xeloda to that of a lower dose of Xeloda plus Taxotere in patients with locally advanced or metastatic breast cancer after failure of chemotherapy with an anthracycline.Patients will be randomized to receive either 1250mg/m2 or 825mg/m2 po bid on days 1-14 of each 3 week cycle, in combination with Taxotere 75mg/m2 iv on day 1 of each 3 week cycle. The anticipated time on study treatment is until disease progression and the target sample size is 100-500 individuals.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Breast Cancer

Intervention

capecitabine [Xeloda], capecitabine [Xeloda], Taxotere

Location

Birmingham
Alabama
United States
35233

Status

Active, not recruiting

Source

Hoffmann-La Roche

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:54:33-0400

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Medical and Biotech [MESH] Definitions

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

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)

Carbohydrate antigen elevated in patients with tumors of the breast, ovary, lung, and prostate as well as other disorders. The mucin is expressed normally by most glandular epithelia but shows particularly increased expression in the breast at lactation and in malignancy. It is thus an established serum marker for breast cancer.

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