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Clinical Trial Summary

This phase II trial studies how well radiation therapy works in treating post-menopausal women with early stage breast cancer undergoing surgery. Radiation therapy uses high energy x rays to kill tumor cells. This may be an effective treatment for breast cancer.


Clinical Trial Description

PRIMARY OBJECTIVE:

I. For select patients with early stage breast cancer undergoing wide local excision followed by single fraction radiation therapy (SFRT), we will evaluate rates of observer-rated toxicity, cosmetic outcomes and patient satisfaction, objective measures of toxicity and quality of life as well as delivery of intended dose.

SECONDARY OBJECTIVE:

I. Locoregional control reported at five years.

OUTLINE:

Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.

After completion of study treatment, patients are followed at 1 week, 1 month, 3 months, and then every 6 months for 2 years. ;


Study Design

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


Related Conditions & MeSH terms

  • Breast Neoplasms
  • Carcinoma
  • Carcinoma in Situ
  • Carcinoma, Ductal
  • Carcinoma, Ductal, Breast
  • Carcinoma, Intraductal, Noninfiltrating
  • Carcinoma, Lobular
  • Ductal Breast Carcinoma In Situ
  • Estrogen Receptor Negative
  • Estrogen Receptor Positive
  • HER2/Neu Negative
  • Invasive Cribriform Breast Carcinoma
  • Invasive Ductal Carcinoma, Not Otherwise Specified
  • Lobular Breast Carcinoma In Situ
  • Mucinous Breast Carcinoma
  • Papillary Breast Carcinoma
  • Progesterone Receptor Positive
  • Stage I Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIC Breast Cancer
  • Tubular Breast Carcinoma

NCT number NCT01754519
Study type Interventional
Source Roswell Park Cancer Institute
Contact
Status Terminated
Phase Phase 2
Start date May 2013
Completion date August 2015

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