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

This study has been withdrawn prior to enrollment.
(No patients enrolled.)
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01255553
First received: November 22, 2010
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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 Intervention
Breast Cancer
Radiation: Partial Breast Irradiation

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Image Guided Partial Breast Irradiation (PBL) In A Low-Risk Population Screened With Magnetic Resonance Imaging (MRI)

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Survival Rates [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Cosmetic outcomes of breast PBI [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Comparison of cosmetic results (appearance, size, shape, texture, scaring) of breast treated with PBI to untreated breast.


Enrollment: 0
Study Start Date: June 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01255553

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

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01255553     History of Changes
Other Study ID Numbers: 09-025-A
Study First Received: November 22, 2010
Last Updated: March 3, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014