Partial Breast Irradiation in a Low-risk Population Screened With MRI
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ClinicalTrials.gov Identifier: NCT01255553
Recruitment Status :
(No patients enrolled.)
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.
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.
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) ]
Secondary Outcome Measures :
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.
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Ages Eligible for Study:
40 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Stage 0 or I breast carcinoma
40 years or older
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
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)