Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer
Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer
To determine whether an accelerated course of radiotherapy delivered to the lumpectomy cavity
 plus margin using IORT as a single dose, intracavitary brachytherapy with the MammoSite
 device over 5 days, partial breast 3-D CRT in 5 days, or stereotactic APBI over 4 days is a
 feasible and safe alternative to a six and a half week course of whole breast radiotherapy.
 The study will measure both short and long-term complications of radiation treatment, short
 and long-term breast cosmesis, local rates of in-breast cancer recurrence, regional
 recurrences, distant metastases, and overall survival.
Inclusion Criteria:

 1. Women >= 40 with invasive ductal carcinoma or ductal carcinoma in situ

 2. Patient chooses lumpectomy rather than mastectomy as treatment for breast cancer

 3. Tumor < 2.5 cm in size, 2 mm margin of normal breast tissue between cancer and edge of
 specimen.

 Exclusion Criteria:

 1. Men

 2. Prior malignancy, breast or other if metastatic or with anticipated survival of < 5
 years

 3. Pregnant women

 4. Immunocompromised

 5. Poorly controlled insulin dependent diabetes

 6. Contraindication to radiotherapy, e.g. connective tissue disorder such as scleroderma

 7. Breast cancer that involves skin or chest wall

 8. Multifocal or Multicentric breast cancer

 9. Invasive lobular carcinoma

 10. Diffuse microcalcifications on mammography

 11. Invasive carcinoma with extensive intraductal component (EIC)

 12. Greater than 12 weeks since definitive surgical excision or completion of chemotherapy

 13. Involved lymph nodes detected by frozen section or touch preparation at time of
 lumpectomy

 14. Patients with 1 to 3 positive lymph nodes determined postoperatively (does not include
 patients with micro-metastases)

 15. Subglandular or submuscular breast implants (does not include patients having implants
 placed AFTER intra-operative radiotherapy)