A Phase I Study of Once-Daily External-Beam Partial-Breast Irradiation (PBI) for Selected Patients With Early Invasive N0 or Non-Invasive Breast Cancer
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
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety of external-beam PBI utilizing 40Gy in ten daily fractions over two weeks
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. Grade 3 or 4 skin/subcutaneous or pulmonary toxicity. The development of clinical fat necrosis. The development of rib fracture on the ipsilateral treated side, detected either clinically and/or radiographically.
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|Beth Isreal Deaconness Medical Center||Boston, Massachusetts 02115|
|Brigham and Women's Hosptial||Boston, Massachusetts 02215|