Neoplasms

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Skin and Connective Tissue Diseases

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Breast Neoplasms

Carcinoma in Situ

Carcinoma, Ductal

Carcinoma, Intraductal, Noninfiltrating

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Adenocarcinoma

Breast Carcinoma In Situ

Patients who have early stage breast cancer, and are candidate for intracavitary accelerated partial breast irradiation may be considered for this study.

34 Gy administered over 10 fractions, twice a day times five days. The radiation therapy treatment will be complete upon the 5th day.

Electronic Brachytherapy

Intracavitary accelerated partial breast irradiation

Peter Beitsch, MD

Rakesh Patel, MD

PRINCIPAL INVESTIGATORS

* Rakesh Patel, MD- Radiation Oncologist
* Peter Beitsch, MD- Breast Surgeon

REGISTRY DESIGN

* Multicenter, non-randomized, post market registry of intracavitary accelerated partial breast irradiation in appropriately selected patients.

SAMPLE SIZE AND SITES:

* Approximately 400 patients may be enrolled.
* Up to 100 qualified U.S. sites may participate in this registry.

ENDPOINTS:

1. PRIMARY ENDPOINTS

   * Subcutaneous Toxicities - The incidence of signs and symptoms of subcutaneous toxicities will be recorded at the following follow-up visits; at six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year.
   * Skin Toxicities - Specific toxicities that can result from radiation therapy will be recorded at each follow-up visit. The Common Terminology Criteria for Adverse Events will be used and to be recorded at each follow-up visits; at one (1) month, six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year.
   * Cosmetic Outcome - Cosmetic outcome will be recorded at the following follow-up visits; at one (1) month, six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year. Cosmetic outcome will be assessed and graded in two ways:
   * Patient Quality of Life Questionnaire - A Quality of Life Questionnaire (QOL) will be completed at the following visits; at one (1) month, six (6) month, one (1) year, two (2) year, three (3) year, four (4) year, and five (5) year.
2. SECONDARY ENDPOINTS

   * Local-regional Breast Failure - The secondary efficacy endpoint is ipsilateral breast failure at five (5) years.

   This includes:
   * Ipsilateral recurrence within the initially treated volume. (Within the tumor bed)
   * Ipsilateral recurrence of cancer outside of the initially treated volume. (Elsewhere Failure)
   * Axillary nodal recurrence

     * Survival - to be recorded at each follow-up visit
   * Overall Survival
   * Disease Free Survival

     * Device Performance - to be recorded during the balloon applicator placement and during the course of the radiation treatments:
   * Ability to deliver treatment
   * Axxent System / Balloon Applicator performance
3. TREATMENT DEVICE

The device to be used is the electronic brachytherapy system for the treatment of early stage breast cancer with intracavitary accelerated partial breast irradiation. The device manufacturer is Xoft, Incorporated. All Xoft technology cleared by the FDA for the treatment of early stage breast cancer can be used in this post market data collection registry.

OVERSIGHT COMMITTEE

Representatives from American Brachytherapy Society (ABS), American Society of Breast Surgeons (ASBS), and American College of Radiation Oncology (ACRO)will oversee study management.

Electronic Xoft Intersociety Brachytherapy Trial: Electronic Brachytherapy (EBT) For Treatment of Early Stage Breast Cancer

Electronic Xoft Intersociety Brachytherapy Trial

Xoft, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Electronic Xoft Intersociety Brachytherapy Trial: Electronic Brachytherapy (EBT) For Treatment of Early Stage Breast Cancer	NCT00742222	Breast Cancer Carcinoma Lumpectomy Ductal Carcinom...	Electronic Brac... Intracavitary a...	50 Years -	Xoft, Inc.
Electronic Xoft Intersociety Brachytherapy Trial: Electronic Brachytherapy (EBT) For Treatment of Early Stage Breast Cancer	NCT00742222	Breast Cancer Carcinoma Lumpectomy Ductal Carcinom...	Electronic Brac... Intracavitary a...	50 Years -	Xoft, Inc.
Electronic Xoft Intersociety Brachytherapy Trial: Electronic Brachytherapy (EBT) For Treatment of Early Stage Breast Cancer	NCT00742222	Breast Cancer Carcinoma Lumpectomy Ductal Carcinom...	Electronic Brac... Intracavitary a...	50 Years -	Xoft, Inc.

Spots Global Cancer Trial Database for intracavitary accelerated partial breast irradiation