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| ID | Type | Description | Link |
|---|---|---|---|
| U54CA142152-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| New Hanover Regional Medical Center | OTHER |
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This study will evaluate the cosmetic outcome and examine factors contributing to cosmetic outcome in women treated with lumpectomy or bilateral breast reduction mammoplasty/mastopexy (BRM) followed by hypofractionated whole breast irradiation. Breast conservation is now an established method of treatment for early breast cancer. Because breast conservation is essentially a cosmetic alternative to mastectomy, quality of life, cosmetic outcome and tumor control are all important considerations during comprehensive treatment planning. Irradiation schemes have been demonstrated to be efficacious and with excellent short term cosmetic outcomes. However, their interaction with currently evolving surgical techniques needs to be examined in order to maintain optimal local control while preserving cosmetic outcome.
Breast cancer outcomes and cosmesis may differ by race. Limited but controversial data suggests that African-American women have worse cosmetic outcomes with hypofractionated irradiation than with conventional breast conservation. A growing body of data also suggests that African-American women have diminished oncologic outcomes when compared to Caucasian women in the United States. Further evaluation is needed to better understand the reason for these discrepancies.
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| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of cosmetic results as judged by the patient, surgeon and radiation oncologist at stated follow-up intervals that will judge cosmesis by serial photography and quality of life (QOL) forms. | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Ipsilateral breast recurrence rate. Disease status will be evaluated at routine patient follow-up appointments including routine mammography. | 10 years | |
| Contralateral breast cancer rate. This will be monitored according to routine protocol including yearly mammograms and clinical breast exams. |
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Inclusion Criteria:
Exclusion Criteria:
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Breast cancer patients who have had a lumpectomy or bilateral reduction mammoplasty followed by hypofractionated irradiation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Belinda Lissor, AAS, CCRP | Contact | 910-251-1839 | blissor@ccradonc.com | |
| Amy Elder, MSN, BSc, CCRP, OCN | Contact | 910-251-1839 | aelder@ccradonc.com |
| Name | Affiliation | Role |
|---|---|---|
| Michael Nichols, MD, PhD | Coastal Carolina Radiation Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Atlantic Radiation Oncology | Active, not recruiting | Supply | North Carolina | 28462 | United States | |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 10 years |
| Coastal Carolina Radiation Oncology |
| Recruiting |
| Wilmington |
| North Carolina |
| 28401 |
| United States |
| Zimmer Cancer Center | Recruiting | Wilmington | North Carolina | 28401 | United States |
| D017437 |
| Skin and Connective Tissue Diseases |