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

Stopped early · Phase 2

Conditions studied: Breast Cancer

In brief

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

Key facts

Study ID

NCT01072838

Run by

SenoRx, Inc.

People needed

60

Starts

2009-12-01

Expected to finish

2013-06-01

Last updated by the study team

2013-06-17

Who can join

Age: 50 and older. Sex: female. Healthy volunteers: not accepted.

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(-)

Where it is running

• William Beaumont Hospital — Royal Oak, Michigan, United States
• Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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