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A Multidisciplinary Protocol for Planned Skin-Preserving Delayed Breast Reconstruction for Patients With Locally Advanced Breast Cancer Requiring Postmastectomy Radiation Therapy


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

A Multidisciplinary Protocol for Planned Skin-Preserving Delayed Breast Reconstruction for Patients With Locally Advanced Breast Cancer Requiring Postmastectomy Radiation Therapy


Study Visits and Surgeries:

You will be hospitalized 2-4 times for 1-5 days depending on your condition. If you agree
to take part in this study, you will be scheduled for a skin-sparing mastectomy. The
following tests and procedures will be performed:

Pre-Operative Visit:

- Your complete medical history will be updated.

- The doctor will determine what type of reconstructive surgery can be done.

- You will have photos taken of your breasts. Your face, hair, or jewelry will not be
photographed. These photos will be kept in a password-protected computer accessible
only by the principle investigator and people directly involved in this study.

- You will complete a quality of life questionnaire. The questionnaire asks about how
satisfied you are with your appearance. The questionnaire will be sent by email, US
postal service mail, or in person when you come for your follow up visits. The
questionnaire should take about 20 minutes to complete. -If sent by US postal service,
you will be given a postage-paid envelope to return the questionnaire.

At your Mastectomy Surgery:

- Your complete medical history will be updated.

- You will have photos taken of your breasts.

- During the surgery, a tissue expander will be placed in your breast. Sterile salt
water will be added to inflate the expander and a small skin sample (about the size of
a pencil eraser) from the breast will be taken to study stretching and scarring of the
skin. The tissue will be securely maintained at MD Anderson.

- You will be monitored for any problems.

Post-Operative Visit - 7 to 10 Days after Mastectomy Surgery:

- The study staff will look at the results of your surgery.

- Your complete medical history will be updated.

- You will complete the quality of life questionnaire.

- You will be asked about any problems you may be having.

Deflation Visit - Week 5:

- Your complete medical history will be updated.

- You will have photos taken of your breasts.

- The sterile salt water in the expander will be let out, causing the breast to go flat.
This is done by inserting a needle into a special port and withdrawing the fluid with a
syringe.

Radiation Visit - Week 8:

- You must have radiation either at M. D. Anderson or an M. D. Anderson-affiliated site.

- Extra fluid may be added to the tissue expander before radiation.

- The study staff will look at the results of your surgery.

- You will be asked about any problems you may be having.

- You will receive radiation, typically 5 days a week for 6 weeks.

Post-Radiation Visits - About Week 13 and every 2 to 4 Weeks after:

- Your complete medical history will be updated.

- The study staff will look at the results of your surgery.

- You will be asked about any problems you may be having.

- You will complete the quality of life questionnaire.

- Your expander will be re-inflated.

Delayed-delayed Reconstruction Surgery - At about Week 23:

- Your complete medical history will be updated.

- You will have photos taken of your breasts.

- During surgery, you will be monitored for any problems. A tissue sample will be
collected to study stretching and scarring of the skin from the mastectomy incision and
the tissue that is used to form the new breast. The tissue will be securely maintained
at MD Anderson.

- During surgery, you will have tissue moved from your lower abdomen, back, or buttock to
be used for reconstruction. A silicone or saline breast implant may or may not be used
to help construct the breast. The amount of tissue used for building the breast will
depend on your body size and donation site. Your reconstructive surgeon will discuss
this with you before surgery.

- During surgery, the expander will be removed and reconstruction of your breast will
occur.

Follow-Up Surgery - At about Week 47:

- Your complete medical history will be updated.

- You will have photos taken of your breasts.

- You will complete the quality of life questionnaire.

- During surgery, you will be monitored for any problems and a tissue sample will be
collected.

- During this surgery, procedures will be done to improve the appearance of the breast.

Long-Term Follow-Up Visits - At 6, 12, 24, and 36 Months:

- Your complete medical history will be updated.

- You will have photos taken of your breasts.

- You will be asked about any problems you may be having.

- At Months 12 and 24, you will complete the quality of life questionnaire.

This is an investigational study. The implants in this study have been FDA approved for
skin expansion as a method of breast reconstruction. The use of the implants is
investigational in this study.

Up to 200 women will take part in this study. All will be enrolled at M. D. Anderson.


Inclusion Criteria:



1. Patients with invasive breast carcinoma that are scheduled for a mastectomy with
planned postmastectomy XRT. This includes, but is not limited to, clinical stage II,
III, and IV.

2. Patient must desire breast reconstruction.

3. Patients must sign the informed consent form and must be deemed by operative surgeon
not to have medical contraindications for delayed-delayed approach.

4. Patients must be 18 years of age or older.

Exclusion Criteria:

1. Patients in whom it is not known preoperatively to need postmastectomy radiation
therapy.

2. Patients with inflammatory breast cancer.

3. Patients in whom the breast skin can not be spared because of involvement with breast
cancer.

4. Any patient deemed by the radiation oncologist during preoperative consultation to be
an inappropriate patient for this protocol.

5. Patients that can not commit to receiving postmastectomy radiation treatment in
addition to breast reconstructive procedures at MD Anderson Cancer Center or
satellite affiliates.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Complication Rate

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Steven J. Kronowitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2010-0053

NCT ID:

NCT01256528

Start Date:

December 2010

Completion Date:

Related Keywords:

  • Breast Cancer
  • Invasive breast carcinoma
  • Breast reconstruction
  • Mastectomy
  • Breast cancer
  • Delayed-delayed breast reconstruction
  • Post-mastectomy radiation therapy
  • Breast Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030