Use of the Contura™ Catheter to Deliver Accelerated Partial Breast Irradiation to Low-risk Breast Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this national, multi-site study is to determine the safety and effectiveness of the Contura catheter in breast cancer patients undergoing accelerated partial breast irradiation.

Detailed Description
-----------------
The Cancer Center of Irvine is one of the busiest centers in the United States for Contura accelerated partial breast irradiation.

Official Title
-----------------
A Multi-Site, Prospective, Non-Randomized Study of the Contura™ Multi-Lumen Balloon (MLB) Catheter to Deliver Accelerated Partial Breast Irradiation: Analysis of Dosimetry, Local Tumor Control, Cosmetic Outcome, and Toxicity

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Device: Accelerated partial breast irradiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able and willing to sign informed consent Age 50 or older at diagnosis Life expectancy greater than 10 years (excluding diagnosis of breast cancer) Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (negative surgical margins per NSABP criteria) On histologic examination, the tumor must be DCIS and/or invasive breast carcinoma For patients with invasive breast cancer, an axillary staging procedure must be performed [either sentinel node biopsy or axillary dissection (with a minimum of 6 axillary nodes removed), and the axillary node(s) must be pathologically negative] The T stage must be Tis, T1, or T2. If T2, the tumor must be less than or equal to 3.0 cm in maximum diameter Estrogen receptor positive tumor Exclusion Criteria: Age < 50 at diagnosis (regardless of histology) Pregnant or breast-feeding Active collagen vascular disease Paget's disease of the breast Prior history of DCIS or invasive breast cancer Prior breast or thoracic radiation therapy for any condition Multicentric carcinoma (DCIS or invasive) Synchronous bilateral invasive or non-invasive breast cancer Surgical margins that cannot be microscopically assessed or that are positive Positive axillary node(s) T stage of T2 with the tumor > 3 cm in maximum diameter or a T stage of T3 or T4 Estrogen receptor negative tumor

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Contura accelerated partial breast irradiation. Following a lumpectomy, a Contura balloon catheter is placed in the lumpectomy cavity. Later that morning, accelerated partial breast irradiation begins. | Device: Accelerated partial breast irradiation<br>* A total radiation dose of 34 Gy is delivered in 10 fractions bid over 5-7 days with 6 hours between the radiation treatments each day. Each radiation treatment takes 15-30 minutes. There is no radioactivity left behind in the patient.<br>* Other names: Contura catheter;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum total skin dose is less than or equal to 125% of the prescribed radiation dose. |  | 19 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity rates |  | 79 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contura, Cancer, Accelerated, Partial, Breast, Irradiation