Safety Study for Short-course Accelerated, Hypofractionated Partial Breast Radiotherapy (APBI) in Women With Early Stage Breast Cancer Using the Contura MLB

June 14, 2013 updated by: SenoRx, Inc.

Safety and Feasibility of Short-Course, Accelerated, Hypofractionated Partial Breast Radiotherapy in Women With Early Stage Breast Cancer Using the Contura MLB Breast Brachytherapy Catheter: A Phase II Trial

To determine local disease control (recurrence) with shorter course of APBI delivered with a breast brachytherapy applicator.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

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
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Cancer Institute of New Jersey
    • Virginia
      • Richmond, Virginia, United States, 23298
        • 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

Female

Description

Inclusion Criteria:

  • Life expectancy > 10 years
  • Lumpectomy with clear margins (negative per NSABP criteria)
  • DCIS and/or invasive carcinoma
  • If invasive, nodes must be negative
  • T stage is Tis, T1 or T2<=3 cm max diameter
  • ER(+) or ER(-)/PR(+)

Exclusion Criteria:

  • Pregnant or breast feeding
  • Active collagen-vascular disease
  • Paget's disease of the breast
  • Prior history of breast cancer
  • Prior breast or thoracic radiotherapy
  • Multicentric carcinoma
  • Synchronous bilateral breast cancer
  • Surgical margins that cannot be assessed or that are positive
  • T Stage is T2>3 cm or greater
  • ER(-)/PR(-)

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
OTHER: Dose Escalation
Radiation: APBI (Dose Escalation)

Accelerated, hypofractionated partial breast radiotherapy.

3 dose schemes followed for 6 months each.

Device: Contura MLB Breast Brachytherapy Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Delivery of short-course APBI will result in locoregional disease control that is equal to that reported for conventional fractionation schemes for APBI.
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

Investigators

  • Principal Investigator: Atif Khan, MD, Rutgers Cancer Institute of New Jersey
  • Principal Investigator: Douglas W. Arthur, MD, Virginia Commonwealth University
  • Principal Investigator: Mihai Ghilezan, MD, William Beaumont Hospitals

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

December 1, 2009

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

February 18, 2010

First Submitted That Met QC Criteria

February 19, 2010

First Posted (ESTIMATE)

February 22, 2010

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

  • S09-001

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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