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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00699101
Recruitment Status : Terminated
First Posted : June 17, 2008
Last Update Posted : June 17, 2013
Sponsor:
Collaborator:
C. R. Bard
Information provided by (Responsible Party):
SenoRx, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Conture Multi-Lumen Balloon Phase 4

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  (Clinical Trial)
Actual Enrollment : 342 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2008
Primary Completion Date : March 2011
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Dosimetric efficacy of the Contura™ MLB with the historical efficacy rate of a single central lumen balloon device. [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Quantify the dosimetric improvement of multi-lumen use over single lumen use through dosimetric comparison. [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00699101


Locations
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298-0058
Sponsors and Collaborators
SenoRx, Inc.
C. R. Bard
Investigators
Study Chair: Douglas W. Arthur, MD Virginia Commonwealth University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: SenoRx, Inc.
ClinicalTrials.gov Identifier: NCT00699101     History of Changes
Other Study ID Numbers: SENORX-S07-002
First Posted: June 17, 2008    Key Record Dates
Last Update Posted: June 17, 2013
Last Verified: June 2013

Keywords provided by SenoRx, Inc.:
Breast Cancer
Conture®
Brachytherapy