Trials / Unknown
UnknownNCT01400399
Cosmetic Evaluation of Lumpectomy Versus Oncolytic Mammoplasty With Bilateral Breast Reduction for Early Stage Breast Cancer
Phase II Evaluation of Hypofractionated Breast Irradiation in Patients Undergoing Standard Lumpectomy or Oncolytic Mammoplasty With Bilateral Breast Reduction
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 84 (estimated)
- Sponsor
- Coastal Carolina Radiation Oncology · Academic / Other
- Sex
- Female
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Timeline
- Start date
- 2010-08-01
- Primary completion
- 2016-08-01
- Completion
- 2020-08-01
- First posted
- 2011-07-22
- Last updated
- 2015-12-09
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01400399. Inclusion in this directory is not an endorsement.