Delayed-Immediate Breast Reconstruction

In women who have a mastectomy and desire breast reconstruction, the best timing of breast
reconstruction depends on whether radiation therapy (XRT) is needed. If XRT is not needed,
immediate reconstruction offers the best cosmetic result. However, if XRT is needed, it is
better to delay reconstruction until XRT is complete. There are 2 reasons to wait. First,
the presence of a reconstructed breast can interfere with the delivery of XRT, decreasing
the effectiveness of this treatment. Second, exposing a reconstructed breast to radiation
can cause poor cosmetic results. Today, many women are not offered immediate reconstruction
because it is not known at the time of their mastectomy whether they will need XRT.
Researchers believe that for such women, a new approach called "delayed-immediate
reconstruction" will offer the cosmetic benefits of immediate reconstruction without the
potential drawbacks of ineffective treatment.

If you agree to take part in this study, you will have your already scheduled skin-sparing
mastectomy. However, at the time of your routine mastectomy, you will also have a tissue
expander or postoperatively adjustable implant (fully inflated with saline or as allowed by
the remaining capacity [space] of the retained breast skin) placed in your breast. Some
patients will have a small biopsy of skin, that is normally discarded, done so that
scientists can learn about changes and ways of healing after radiation. When the final
pathology report is complete (about 1 week after mastectomy), the radiation doctor and/or
your surgeon will decide whether or not you need XRT.

If the results show that you do not need XRT, you will have the tissue expander or implant
removed and will have standard definitive breast reconstruction, using the preserved breast
skin about 2 weeks after mastectomy. The reconstructive technique used will be decided based
on anatomical considerations, surgical factors, and your personal desires. The postoperative
follow-up will be similar to that of patients who have standard immediate breast
reconstruction.

If the results show that you do need XRT, the tissue expander or adjustable implant will be
completely deflated in the plastic surgery clinic before you receive standard XRT. Radiation
must be given either at MD Anderson or an MD Anderson-affiliated site. Deflation of the
tissue expander or implant will result in a flat chest wall that will decrease difficulties
with radiation delivery that can occur after an immediate breast reconstruction. If you also
require chemotherapy after mastectomy, the tissue expander or implant will remain inflated
during chemotherapy (additional saline-filling may also be performed during chemotherapy, if
required). In patients who have already received chemotherapy before mastectomy or who will
not require chemotherapy, the expander or implant will remain inflated during the
4-to-6-week period between mastectomy and XRT. About 3 weeks into your radiation treatments,
you will come in to the plastic surgery clinic for a follow-up to check on the status of the
implants.

Several weeks after the completion of XRT, the tissue expander or postoperatively adjustable
implant will be gradually re-expanded over about 6-months. The internal scar capsule that
forms around the tissue expander or implant before deflation usually allows for re-expansion
after radiation therapy. Re-expansion after radiation therapy will be performed during
postoperative visits to the plastic surgery clinic every 2-to-4 weeks until the desired size
is achieved. About 6 months after the completion of XRT, a "skin-preserving" delayed
reconstruction with a preference for autologous tissues only (no breast implants) will be
performed. This will involve removal of the tissue expander or implant and definitive breast
reconstruction. At the time of the skin-preserving delayed reconstruction, a small biopsy of
usually thrown away radiated breast tissue as well as a sample of the skin, that is normally
discarded, of the flap (your tissue that is taken from your back, stomach or buttock to
build the breast) and a sample of the implant or tissue expander will be collected for
laboratory evaluation. Researchers will evaluate the skin changes from radiation and
expansion as well as from the internal scar capsule. This will be compared to radiated skin
biopsies without expansion and biopsies taken after skin expansion without radiation.

Your medical information and photographs of your breast(s) will be gathered throughout the
various stages of delayed-immediate reconstruction.

Delayed-immediate breast reconstruction is a two-stage approach and as such involves at
least 2 surgical procedures. This does not include the possibility of procedures needed to
modify the reconstructed breast, a procedure on the healthy breast to make it symmetrical
(similar in appearance and size) with the reconstructed breast, and any nipple
reconstruction and areolar tattooing that may be needed. If, later on, it is necessary to
revise the reconstructed breast, a small skin sample (smaller than a pencil eraser) will
again be collected for additional studies. This will not affect the outcome of your surgery
or the way your breast will look.

The postoperative course, follow-up, and the need for additional surgical procedures will be
decided in a similar fashion to that of standard immediate and delayed breast
reconstruction.

This is an investigational study. The implants in this study have been FDA approved for skin
expansion as a method of breast reconstruction. They are not specifically approved for both
expansion and radiation. About 200 women will take part in this study. All will be enrolled
at MD Anderson Cancer Center (MDACC).

Inclusion Criteria:

1. Patients with clinical stage I or stage II breast cancer who may require
postmastectomy XRT.

2. Patients will be required to receive postmastectomy XRT as well as breast
reconstructive procedures, including subsequent deflation and re-inflation of the
prosthesis after XRT at University of Texas MD Anderson Cancer Center (UT MDACC).

3. Patients must sign the consent form and must be able to withstand two (2) anesthetic
procedures.

4. Patients with stage I breast cancer who will be eligible for delayed-immediate breast
reconstruction will have extensive microcalcifications within the affected by
mammography that make it difficult to determine preoperatively the extent of invasive
disease.

Exclusion Criteria:

1. Patients with stage III or stage IV breast cancer who are known preoperatively to
require postmastectomy XRT.

2. Patients with stage I breast cancer who are unlikely to require postmastectomy XRT.