Using the Conture® Multi-Lumen Balloon to Deliver Accelerated Partial Breast Brachytherapy

Study Overview
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Brief Summary
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This multiple site, prospective, non-randomized study has been designed to compile information on the efficacy of the Contura™ MLB in delivering APBI in appropriately selected patients through evaluation of dosimetric success as compared with a single central lumen balloon device and through treatment outcomes.

Detailed Description
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Data collected during this study will include baseline patient demographics, information related to the time of implant, radiation therapy details, and removal of the device as well as recurrence data, cosmetic outcomes and toxicities. The patient's follow-up data will be collected during the patient's standard follow-up visits.

Official Title
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A Multi-site Prospective, Non Randomized Study Utilizing the Conture® Multi-Lumen Balloon (MLB) Breast Brachytherapy Applicator to Deliver Accelerated Partial Breast Irradiation: Analysis of Dosimetric Success, Local Tumor Control, Cosmetic Outcome, Acute and Chronic Toxicity, and Clinical Scenarios for Optimal Use

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Conture Multi-Lumen Balloon


Participation Criteria
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Eligibility Criteria
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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 or invasive breast carcinoma. For patients with invasive breast cancer, an axillary staging procedure must be performed. Either: sentinel node biopsy (SNB) alone if sentinel node(s) is/are negative; or axillary dissection (minimum of six 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 ≤ 3.0 cm in maximum diameter. Estrogen receptor positive tumor Exclusion Criteria: Age < 50 at diagnosis (regardless of histology) Pregnant or breast-feeding (if appropriate, patient must use birth control during the study) Active collagen-vascular disease Paget's disease of the breast History of DCIS or invasive breast cancer Prior breast or thoracic RT 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 or close Positive axillary node(s) T stage of T2 with the tumor > 3 cm in maximum diameter or a T stage > 3 Estrogen receptor negative tumor

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Conture Multi-Lumen Balloon | Device: Conture Multi-Lumen Balloon<br>* Placement of the balloon in a separate procedure using ultrasound guidance after surgery for breast cancer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosimetric efficacy of the Contura™ MLB with the historical efficacy rate of a single central lumen balloon device. |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantify the dosimetric improvement of multi-lumen use over single lumen use through dosimetric comparison. |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Conture®, Brachytherapy