NCT00699101

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
342

participants targeted

Target at P75+ for phase_4 breast-cancer

Timeline
Completed

Started Jun 2008

Longer than P75 for phase_4 breast-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 12, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

June 17, 2013

Status Verified

June 1, 2013

Enrollment Period

2.7 years

First QC Date

June 12, 2008

Last Update Submit

June 14, 2013

Conditions

Breast Cancer

Keywords

Breast CancerConture®Brachytherapy

Outcome Measures

Primary Outcomes (1)

  • Dosimetric efficacy of the Contura™ MLB with the historical efficacy rate of a single central lumen balloon device.

    5 years

Secondary Outcomes (1)

  • Quantify the dosimetric improvement of multi-lumen use over single lumen use through dosimetric comparison.

    5 years

Study Arms (1)

A

EXPERIMENTAL

Conture Multi-Lumen Balloon

Device: Conture Multi-Lumen Balloon

Interventions

Conture Multi-Lumen BalloonDEVICE

Placement of the balloon in a separate procedure using ultrasound guidance after surgery for breast cancer.

A

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298-0058, United States

Location

Related Publications (1)

  • Cuttino LW, Arthur DW, Vicini F, Todor D, Julian T, Mukhopadhyay N. Long-term results from the Contura multilumen balloon breast brachytherapy catheter phase 4 registry trial. Int J Radiat Oncol Biol Phys. 2014 Dec 1;90(5):1025-9. doi: 10.1016/j.ijrobp.2014.08.341. Epub 2014 Oct 13.

    PMID: 25442036DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Douglas W. Arthur, MD

    Virginia Commonwealth University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2008

First Posted

June 17, 2008

Study Start

June 1, 2008

Primary Completion

March 1, 2011

Study Completion

June 1, 2013

Last Updated

June 17, 2013

Record last verified: 2013-06

Locations

US(1)