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

This study is currently recruiting participants.

Verified January 2013 by SenoRx, Inc.

Sponsor:

Collaborator:

C. R. Bard

Information provided by (Responsible Party):

SenoRx, Inc.

ClinicalTrials.gov Identifier:

NCT01072838

First received: February 18, 2010

Last updated: January 9, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

February 18, 2010

Last Updated Date

January 9, 2013

Start Date ^ICMJE

December 2009

Estimated Primary Completion Date

December 2016 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01072838 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Radiation: APBI (Dose Escalation)
Accelerated, hypofractionated partial breast radiotherapy.

3 dose schemes followed for 6 months each.
Device: Contura MLB Breast Brachytherapy Catheter

Study Arm (s)

Dose Escalation

Interventions:

Radiation: APBI (Dose Escalation)
Device: Contura MLB Breast Brachytherapy Catheter

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

December 2016 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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(-)

Gender

Female

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Natasha Behrmann

949-362-4800 ext 145

Natasha.Behrmann@crbard.com

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01072838

Other Study ID Numbers ^ICMJE

S09-001

Has Data Monitoring Committee

Yes

Responsible Party

SenoRx, Inc.

Study Sponsor ^ICMJE

SenoRx, Inc.

Collaborators ^ICMJE

C. R. Bard

Investigators ^ICMJE

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

Information Provided By

SenoRx, Inc.

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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