Breast Cancer
Conditions
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.
Interventions
RADIATIONPartial 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.
Sponsors
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Survival Rates | 5 years | — |
| Cosmetic outcomes of breast PBI | 3 years | Comparison of cosmetic results (appearance, size, shape, texture, scaring) of breast treated with PBI to untreated breast. |
Countries
United States
Outcome results
None listed