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A Registry Study of Permanent Breast Seed Implant

2014-07-24 14:06:32 | BioPortfolio

Summary

Women found to have early stage breast cancer will have their cancer surgically removed followed by radiation treatment to the entire breast, five times per week for several weeks. The radiation treatment prevents the cancer from growing back but creates skin burns. Several studies have showed that it is nor necessary treating the whole breast.

The investigators team has pioneered a new therapy realizing the permanent implantation of tiny radioactive seeds into the surgical cavity in a single one hour procedure under light anesthesia. Patients live a normal life while receiving the radiation treatment. The results of a first clinical trial on 67 patients shows that the treatment is well tolerate and efficient. The purpose of the study is to offer the treatment in several places and to increase the cohort of patient to 420 to capture rare complications if any.

Description

For early stage breast cancer, accelerated partial breast irradiation is an alternative treatment option to whole breast irradiation after breast conserving surgery. Our group has previously reported results of a Phase I/II study of permanent breast seed implant (PBSI) using palladium-103 seeds as an alternative to whole breast radiotherapy for well selected breast cancer patients. The procedure is realised in a single session under light sedation and local freezing. After a median FU of 54 months no patients has recurred on a cohort of 67 patients, and acute of delayed side effect compared favourably to external beam radiotherapy.

Yet this study was a single centre study and the sample size did not allow evaluating appropriately the risk of serious adverse events (SAE). The current study propose evaluating SAE on a multicentre and larger cohort of 420 patients.

Study Design

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

Conditions

Breast Neoplasms

Intervention

Permanent breast seeds implant

Location

Sunnybrook Odette Cancer Centre
Toronto
Ontario
Canada
M4N3M5

Status

Recruiting

Source

Sunnybrook Health Sciences Centre

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:06:32-0400

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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.

A fluid-filled closed cavity or sac that is lined by an EPITHELIUM and found in the BREAST. It may appear as a single large cyst in one breast, multifocal, or bilateral in FIBROCYSTIC BREAST DISEASE.

Breast neoplasms that do not express ESTROGEN RECEPTORS; PROGESTERONE RECEPTORS; and do not overexpress the NEU RECEPTOR/HER-2 PROTO-ONCOGENE PROTEIN.

Any neoplasms of the male breast. These occur infrequently in males in developed countries, the incidence being about 1% of that in females.

Tumors or cancer of the human BREAST.

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