Status:
WITHDRAWN
Partial Breast Irradiation in a Low-risk Population Screened With MRI
Lead Sponsor:
University of Chicago
Conditions:
Breast Cancer
Eligibility:
FEMALE
40+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01255553
Start Date
June 1 2009
End Date
May 1 2012
Last Update
March 4 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Chicago
Chicago, Illinois, United States, 60637