TriangleThe film gives the main points. The full list below is copied from the registry; the study team makes the final decision.
- Age40 Years to no maximum
- SexFemale
- Healthy volunteersNo
You may be able to join if
- For all participants
- Participants should have no contraindications to undergo MRI scan as part of radiotherapy planning and treatment.
- Lumpectomy cavity must be clearly visible on CT and MRI scan at radiotherapy simulation.
- Pregnancy test negative in women of child bearing potential (WOCBP).
- The participant must consent to be in the study and must have signed an approved consent form conforming with institutional guidelines.
- Participants with a history of non-breast malignancies are eligible if they have been disease-free for 5 or more years prior and are deemed by their physician to be at low risk for recurrence. Participants with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
- For participants with Invasive Carcinoma
- Suitable:
- Age: >=50 years
- Margins: Negative by at least 2 mm
- T Stage: Tis or T1
- Cautionary:
- Age: 40-49 years
- Margins: Negative by at least 2 mm
- T Stage: Tis or T1 OR
- Age: >=50 years IF participant has at least 1 of the pathologic factors below and does not have any "unsuitable" factors (below)
- Pathologic Factors:
- Size 2.1-3.0 cm (size of the invasive component)
- T2
- Close margins (<2 mm)
- Limited/focal Lymphovascular Space Invasion (LVSI)
- ER (-)
- Clinically unifocal with total size 2.1-3.0 cm (Microscopic multifocality allowed, provided the lesion is clinically unifocal (a single discrete lesion by physical examination and ultrasonography/mammography) and the total lesion size (including foci of multifocality and intervening normal breast parenchyma) falls between 2.1 and 3.0 cm).
- Invasive lobular histology
- Extensive Intraductal Component (EIC) <=3 cm
- For participants with DCIS
- Suitable Criteria, DCIS allowed if all of the following are met:
- Screen-detected
- Low to intermediate nuclear grade
- Size <=2.5 cm
- Resected with margins negative at >=3mm OR
- Cautionary Criteria:
- Pure DCIS <=3 cm if "suitable" criteria not fully met
- Exclusion Criteria (unsuitable criteria) :
- Men are not eligible for this study.
- BRCA1/2 mutation positivity.
- Age < 40 years (American Society for Radiation Oncology (ASTRO) Unsuitable Criteria).
- Positive resection margins on post operative pathology(ASTRO Unsuitable Criteria).
- Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.
- Suspicious micro calcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign.
- Non-epithelial breast malignancies such as sarcoma or lymphoma.
- Proven multicentric carcinoma (invasive cancer or DCIS) (ASTRO Unsuitable Criteria).
- Pure DCIS >3 cm in size (ASTRO Unsuitable Criteria).
- Presence of extensive intraductal component >30mm (ASTRO Unsuitable Criteria).
- Paget's disease of the nipple.
- History of previous invasive breast cancer, DCIS, synchronous bilateral invasive or non-invasive breast cancer. (Participants with a history of LCIS treated by surgery alone are eligible.)
- Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation.
- Concurrent therapy with any hormonal agents such as raloxifene (Evista®), tamoxifen, Aromatase Inhibitors or other selective estrogen receptor modulators (SERMs), either for osteoporosis or breast cancer prevention or neoadjuvant therapy.
- Breast implants.
- Prior breast or thoracic radiotherapy for any condition or treatment plan that includes regional nodal irradiation.
- Collagen vascular disease, specifically dermatomyositis with a creatinine phosphokinase level above normal or with an active skin rash, systemic lupus erythematosus, or scleroderma.
- Pregnancy or lactation at the time of treatment. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy.
- Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the participant from meeting the study requirements.