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ICI 182780 in Treating Women With Stage I or Stage II Primary Breast Cancer

2014-08-27 03:57:09 | BioPortfolio

Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using ICI 182780 before surgery may block the uptake of estrogen by the tumor cells and prevent metastases. It is not yet known if ICI 182780 is effective in preventing breast cancer metastases.

PURPOSE: Randomized phase III trial to study the effectiveness of ICI 182780 given before surgery in treating women who have stage I or stage II primary breast cancer.

Description

OBJECTIVES:

- Determine the inhibitory effect of ICI 182780 on the development of metastasis, as measured by disease-free survival and overall survival, in women with operable stage I or II primary breast cancer.

- Determine toxicity of this regimen in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center and menopausal status (premenopausal vs postmenopausal).

Patients are randomized to receive either ICI 182780 IM or placebo IM over 2 minutes on day 1. Patients undergo surgery between days 8 and 29.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 3,656 patients (1,828 per arm) will be accrued for this study within 2 years.

Study Design

Primary Purpose: Treatment

Conditions

Breast Cancer

Intervention

fulvestrant, conventional surgery

Location

Christie Hospital N.H.S. Trust
Manchester
England
United Kingdom
M20 4BX

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:57:09-0400

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Medical and Biotech [MESH] Definitions

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.

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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