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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01255553
Recruitment Status : Withdrawn (No patients enrolled.)
First Posted : December 7, 2010
Last Update Posted : March 4, 2014
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: Partial Breast Irradiation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Image Guided Partial Breast Irradiation (PBL) In A Low-Risk Population Screened With Magnetic Resonance Imaging (MRI)
Study Start Date : June 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Intervention Details:
  • Radiation: Partial Breast Irradiation
    Partial breast irradiation will be administered using a 3D conformal external beam RT technique. Two fractions of 38.5 Gy separated by at least 6 hours will be given on 5 treatment days over a period of 5 to 10 days.

Primary Outcome Measures :
  1. Rates of toxicity (breast edema/pain, hyperpigmentation, erythema) for patients receiving partial breast irradiation (PBI) compared to historical rates of toxicity of patients receiving whole breast irradiation (WBI) [ Time Frame: During radiation therapy (5-10 days) ]
  2. Rates of toxicity (breast edema/pain, hyperpigmentation, erythema) for patients receiving PBI compared to historical rates of toxicity of patients receiving WBI [ Time Frame: Post therapy (until death) ]

Secondary Outcome Measures :
  1. Survival Rates [ Time Frame: 5 years ]
  2. Cosmetic outcomes of breast PBI [ Time Frame: 3 years ]
    Comparison of cosmetic results (appearance, size, shape, texture, scaring) of breast treated with PBI to untreated breast.

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01255553

United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Principal Investigator: Steven Chmura, MD University of Chicago

Responsible Party: University of Chicago Identifier: NCT01255553     History of Changes
Other Study ID Numbers: 09-025-A
First Posted: December 7, 2010    Key Record Dates
Last Update Posted: March 4, 2014
Last Verified: March 2014