Cosmetic Result/Toxicity in Post-Mastectomy Immediate Reconstruction Expander+RT

- ADMs have been used in combination with a tissue expander and radiotherapy but have not
been studied formally in terms of their ability to avoid complications sometimes seen
with other methods of reconstruction and improve the delivery of the radiation. The only
difference between being on the study and not being on the study is that the research
team will analyze the records of those who participate to see how easy it was to give
the radiation, how good the cosmetic outcome of the reconstruction is and what, if any,
complications occured.

- A minimum of 6 weeks between the surgery and the start of radiation therapy is required
to allow for adequate healing. Often this interval will be longer, as many patients will
receive chemotherapy in the interim. There is no maximum time from surgery to radiation.

- Around the time of radiation planning, the radiation oncologist and plastic surgeon will
agree upon how much deflation of the tissue expander will be required to permit
simulation of the radiation therapy.

- Radiation therapy to the chest wall (with or without adjacent lymph nodes) will be given
once daily Monday through Friday over 5-7 weeks.

- After the completion of the radiation therapy, the tissue expander will be re-expanded
and eventually replaced by the permanent implant or flap reconstruction at the
discretion of the plastic surgeon.

- Participants will be expected to return to the Radiation Oncology Clinic for follow-up
visits 6, 12, 18 and 24 months after the end of the radiation therapy. Evaluation of
cosmetic results and complications will be done at these visits using a recognized
scoring system and photographs taken at each time point and scored for specific items
(necrosis, telangiectasia, etc).

Inclusion Criteria:

- Patients must have newly diagnosed, clinical Stage I-III breast cancer with T1-T3
invasive tumors recently treated with mastectomy

- Patients must have had immediate reconstruction with a TE and ADM

- Participants must be candidates for postmastectomy radiation therapy (RT).
Postmastectomy RT routinely is indicated for patients with pathologically-staged T3N1
(or higher stage) tumors, T1-T2 tumors with 4 or more positive nodes, some T1-T2
tumors with 1-3 positive nodes, and, infrequently, for some N0 tumors

- Axillary nodes may be positive or negative

- Microscopically positive margins are permitted

- Systemic therapy as recommended by a medical oncologist, pre-or post-mastectomy, is
permitted

- Patients must agree to return for scheduled follow-up visits with their radiation
oncologist 6, 12, 18 and 24 months after RT (+/- 1 month)

- 18 years of age or older

Exclusion Criteria:

- Participants with T4 tumors

- Participants with recurrent breast cancer or a history of prior breast RT

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Pregnant women are excluded from this study

- Individuals with a history of a different malignancy are ineligible except for the
following circumstances. Individuals with a history of other malignancies are eligible
if they have been disease-free for at least 5 years and are deemed by the investigator
to be at low risk for recurrence of that malignancy. Individuals with the following
cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer
in situ, and basal cell or squamous cell carcinoma of the skin

- HIV-positive individuals on combination antiretroviral therapy