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

June 14, 2013 updated by: SenoRx, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

342

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Richmond, Virginia, United States, 23298-0058
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

    1. sentinel node biopsy (SNB) alone if sentinel node(s) is/are negative; or
    2. axillary dissection (minimum of six axillary nodes removed); and
    3. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SenoRx, Inc.

Collaborators

C. R. Bard

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

June 12, 2008

First Submitted That Met QC Criteria

June 12, 2008

First Posted (ESTIMATE)

June 17, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 17, 2013

Last Update Submitted That Met QC Criteria

June 14, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SENORX-S07-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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