NCT01072838

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

3 active sites

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

December 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 22, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day 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

3.5 years

First QC Date

February 18, 2010

Last Update Submit

June 14, 2013

Conditions

Breast Cancer

Keywords

breast cancerAPBIbrachytherapyContura

Outcome Measures

Primary Outcomes (1)

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

    5 years

Study Arms (1)

Dose Escalation

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

Interventions

APBI (Dose Escalation)RADIATION

Accelerated, hypofractionated partial breast radiotherapy. 3 dose schemes followed for 6 months each.

Dose Escalation
Contura MLB Breast Brachytherapy CatheterDEVICE
Dose Escalation

Eligibility Criteria

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

You may qualify if:

  • 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(+)

You may not qualify if:

  • 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(-)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Atif Khan, MD

    Rutgers Cancer Institute of New Jersey

    PRINCIPAL INVESTIGATOR

  • Douglas W. Arthur, MD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

  • Mihai Ghilezan, MD

    Corewell Health East

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2010

First Posted

February 22, 2010

Study Start

December 1, 2009

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

June 17, 2013

Record last verified: 2013-06

Locations

US(3)