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Erlotinib in Treating Women With Locally Advanced or Metastatic Breast Cancer

2014-08-27 03:56:35 | BioPortfolio

Summary

RATIONALE: Some tumors need growth factors produced by the body's white blood cells to keep growing. Erlotinib may interfere with the growth factor and may stop the tumor from growing.

PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating women who have progressive or recurrent, locally advanced or metastatic breast cancer.

Description

OBJECTIVES: I. Determine the objective response rate in women with progressive or recurrent, locally advanced or metastatic breast cancer treated with erlotinib. II. Determine the safety of this drug in these patients. III. Determine the duration of objective response, time to disease progression, and duration of survival in patients treated with this drug. IV. Determine the proportion of patients with stable disease for at least 4 months after treatment with this drug. V. Determine potential factors that contribute to inter-patient variability in pharmacokinetic behavior in patients treated with this drug. VI. Determine exposure-effect relationships in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to disease progression on or after prior therapy (anthracycline, taxane, and capecitabine vs at least 1 chemotherapy regimen for metastatic disease). Patients receive oral erlotinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 42-200 patients (21-150 in stratum 1 and 21-50 in stratum 2) will be accrued for this study.

Study Design

Primary Purpose: Treatment

Conditions

Breast Cancer

Intervention

erlotinib hydrochloride

Location

Jonsson Comprehensive Cancer Center, UCLA
Los Angeles
California
United States
90095-1781

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:56:35-0400

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Medical and Biotech [MESH] Definitions

A quinazoline derivative and ANTINEOPLASTIC AGENT that functions as a PROTEIN KINASE INHIBITOR for EGFR associated tyrosine kinase. It is used in the treatment of NON-SMALL CELL LUNG 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)

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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