Partial Breast Irradiation in a Low-risk Population Screened With MRI

Withdrawn before enrolling · Not applicable

Conditions studied: Breast Cancer

In brief

This is a pilot study to determine if partial breast irradiation (PBI) limited to the region of the tumor bed following lumpectomy in patients screened with MRI provides historically similar rates of local failure, limited acute skin toxicity, late complications and cosmetic outcome when compared to patients treated with standard 3D-CRT to the whole breast.

Key facts

Study ID

NCT01255553

Run by

University of Chicago

People needed

0

Starts

2009-06-01

Expected to finish

2012-05-01

Last updated by the study team

2014-03-04

Who can join

Age: 40 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Stage 0 or I breast carcinoma
• 40 years or older
• Post menopausal
• Lumpectomy with clear margins (>2mm)
• Patients with invasive disease must have undergone an axillary staging by axillary dissection (with a minimum of 6 axillary nodes) or sentinal node biopsy
• Gross disease must be unifocal with pathological tumor size 2cm or less
• Target lumpectomy cavity must be clearly marked with surgical clips (the target lumpectomy cavity/whole breast reference volume must be <=30% based on the postoperative imaging)
• Bilateral MRI of the breasts within previous 6 months of radiation therapy (RT) planning
• If patient is eligible based on postoperative imaging, partial breast irradiation (PBI) is judged to be technically deliverable
• Patients with a history of malignancies are eligible if they have stable disease as determined by their attending oncologist
• Patient must have signed the consent form

You may not qualify if…

• Men are not eligible
• Patients with Stage II, II, or IV breast cancer
• Pre- or peri-menopausal patients
• Patients with positive lymph nodes
• Patients with suspicious microcalcifications, densities, or palpable abnormalities unless biopsied and found to be benign
• Patients with multifocal, multicentric, or bilateral breast cancer
• Surgical margins that cannot be microscopically assessed or are positive at pathological evaluation
• Patients with a history of breast cancer
• Clear delineation of the extent of the target lumpectomy cavity is not possible
• Breast implants (patients who have had implants removed are eligible)
• Prior breast or thoracic RT for any condition

Where it is running

• University of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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