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

NCT01255553 | Withdrawn

• 1 other identifier: 09-025-A
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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)

  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

  Post therapy (until death)

Secondary Outcomes (2)

• Survival Rates

  5 years

• Cosmetic outcomes of breast PBI

  3 years

Interventions

Partial Breast Irradiation RADIATION

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 Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage 0 or I breast carcinoma
• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Steven Chmura, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2010
• First Posted: December 7, 2010
• Study Start: June 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: March 4, 2014

Record last verified: 2014-03

Locations

US (1)