NCT01754519

Radiation Therapy in Treating Post-Menopausal Women With Early Stage Breast Cancer Undergoing Surgery

Phase II Trial of Single Fraction Radiation Therapy (SFRT) at Roswell Park Cancer Institute for Select Patients With Early Stage Breast Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• 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

Interventions

Type	Name	Description
PROCEDURE	Therapeutic Conventional Surgery	Undergo wide local excision breast surgery
RADIATION	Radiation Therapy	Undergo SFRT
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Quality-of-Life Assessment	Ancillary studies

Timeline

• Start date: 2013-05-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2012-12-21
• Last updated: 2017-07-07
• Results posted: 2017-06-06

Locations

1 site across 1 country: United States