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

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
APBI (Dose Escalation)
Contura MLB Breast Brachytherapy Catheter
Sponsored by
SenoRx, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, APBI, brachytherapy, Contura

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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(-)

Sites / Locations

  • William Beaumont Hospital
  • Cancer Institute of New Jersey
  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Dose Escalation

Arm Description

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
February 18, 2010
Last Updated
June 14, 2013
Sponsor
SenoRx, Inc.
Collaborators
C. R. Bard
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1. Study Identification

Unique Protocol Identification Number
NCT01072838
Brief Title
Safety Study for Short-course Accelerated, Hypofractionated Partial Breast Radiotherapy (APBI) in Women With Early Stage Breast Cancer Using the Contura MLB
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Terminated
Study Start Date
December 2009 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SenoRx, Inc.
Collaborators
C. R. Bard

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, APBI, brachytherapy, Contura

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation
Arm Type
Other
Intervention Type
Radiation
Intervention Name(s)
APBI (Dose Escalation)
Intervention Description
Accelerated, hypofractionated partial breast radiotherapy. 3 dose schemes followed for 6 months each.
Intervention Type
Device
Intervention Name(s)
Contura MLB Breast Brachytherapy Catheter
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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(-)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atif Khan, MD
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Douglas W. Arthur, MD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mihai Ghilezan, MD
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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