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

This study has been terminated.
Sponsor:
Collaborator:
C. R. Bard
Information provided by (Responsible Party):
SenoRx, Inc.
ClinicalTrials.gov Identifier:
NCT01072838
First received: February 18, 2010
Last updated: June 14, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention Phase
Breast Cancer
Radiation: APBI (Dose Escalation)
Device: Contura MLB Breast Brachytherapy Catheter
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by SenoRx, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: December 2009
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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(-)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01072838

Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, New Jersey
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
SenoRx, Inc.
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
  More Information

No publications provided

Responsible Party: SenoRx, Inc.
ClinicalTrials.gov Identifier: NCT01072838     History of Changes
Other Study ID Numbers: S09-001
Study First Received: February 18, 2010
Last Updated: June 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by SenoRx, Inc.:
breast cancer
APBI
brachytherapy
Contura

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014