ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT01255553
Recruitment Status : Withdrawn (No patients enrolled.)
First Posted : December 7, 2010
Last Update Posted : March 4, 2014
Sponsor:
Information provided by (Responsible Party):
University of Chicago

November 22, 2010
December 7, 2010
March 4, 2014
June 2009
May 2012   (Final data collection date for primary outcome measure)
  • 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) ]
  • 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) ]
Same as current
Complete list of historical versions of study NCT01255553 on ClinicalTrials.gov Archive Site
  • Survival Rates [ Time Frame: 5 years ]
  • 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.
Same as current
Not Provided
Not Provided
 
Partial Breast Irradiation in a Low-risk Population Screened With MRI
Image Guided Partial Breast Irradiation (PBL) In A Low-Risk Population Screened With Magnetic Resonance Imaging (MRI)
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.
Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
217
May 2012
May 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
40 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01255553
09-025-A
No
Not Provided
Not Provided
University of Chicago
University of Chicago
Not Provided
Principal Investigator: Steven Chmura, MD University of Chicago
University of Chicago
March 2014

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