Breast Cup Immobilization Device II (GCC 1047)

Breast conserving therapy (BCT) has become the standard of care for treating early-stage
breast cancers based on six prospective randomized trials with 20 years of follow-up data
(Fisher). During lumpectomy, the surgeon removes the tumor and a surrounding rim of normal
tissue (margin), leaving surgical clips to help designate the resection bed. Radiation
treatment is directed at the whole breast for 5 1/2 weeks and is generally followed by a 1-2
week boost directed at the lumpectomy site plus a margin of normal breast tissue. The benefit
of adding the tumor bed boost, (TBB) has been shown in two studies to decrease local failures
[Romestaig; Bartelink].

Studies have evaluated the role of radiation following lumpectomy in very select groups which
have not been able to define a group who do not benefit from the addition of radiotherapy. In
the group of patients who received surgery alone, 85% of the breast recurrences occurred in
the tumor bed. Due to these two facts, radiotherapy directed only at the tumor bed has been
evaluated. Treating this smaller tumor volume has allowed higher doses of radiation to be
delivered safely shortening the treatment course from 6-7 weeks to one week.

Inclusion Criteria:

1. The patient must consent to be in the study and have signed an IRB-approved consent
form.

2. The patient must have a diagnosis of invasive or non-invasive breast cancer.

3. The patient must be planned for or have already had breast conservation surgery (i.e.
lumpectomy).

4 Age > 18. 5. There are at least two metal clips in the surgical cavity placed at the time
of surgery for guiding the radiation oncologist in delineating the target of irradiation;
or one radiographic clip placed at the time of stereotactic core needle biopsy with the
intact tumor.

6. Patients who have already been treated by radiation therapy and are being seen in
follow-up can also participate

Exclusion Criteria:

1. Male gender

2. Patients who cannot be set up comfortably in the prone position (e.g. physical
disability)

3. Tumor/lumpectomy site located in a portion of the breast that cannot be visualized
easily on the CT scan (e.g. superior portion of the upper outer quadrant).

4. Mastectomy was or is the recommended surgical approach.