External-Beam Partial-Breast Irradiation for Early Breast Cancer 40 Gy QD Over 2 Weeks

• Safety of external-beam PBI utilizing 40Gy in ten daily fractions over two weeks [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

  To evaluate the safety of external-beam PBI in selected stages 0 and I female breast cancer patients utilizing 40 Gy in ten daily fractions over two weeks. The study will be deemed too toxic if >10% of enrolled patients have at least one of the following outcomes within 24 months of completion of PBI.

  1. Grade 3 or 4 skin/subcutaneous or pulmonary toxicity.
  2. The development of clinical fat necrosis.
  3. The development of rib fracture on the ipsilateral treated side, detected either clinically and/or radiographically.
  
  

• Evaluate local control rates [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  To evaluate local control rates (analyzed separately for patients with DCIS and invasive cancer)
  
  
• Evaluate distant control rates [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  To evaluate distant control rates
  
  
• Evaluate breast cosmesis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  Breast Cosmesis will be assessed pretreatment, at the end of treatment, 4-9 weeks following completion of treatment, every 6 months for the first 5 years, then annually for 5 years. The Cosmetic Scoring System (Appendix 2) will be used.
  
  

After signing the consent form, the following will be assessed.

-CT scan of the breast that had the cancer removed to help plan the radiation therapy. This is referred to as a CT-simulation. This scan is done routinely as part of the regular treatment.

PBI Study Treatment: You will be given PBI once daily over 10 treatment days (Mon-Fri) over a 2 week period. During this time you will have a weekly interview, physical examination, and your skin will be assessed for any side effects of the radiation.

PBI will begin between 4 weeks to 3 months after breast surgery or 2-6 weeks after chemotherapy (if you have been given chemotherapy).

After the final dose of the study:

You will have the following scheduled follow-up visits: one at the completion of the radiation, once or twice during weeks 3-9 after the completion of radiation, once every 6 months for five years, and then once every year for the following five years after the completion of radiation therapy.