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Partial Breast Proton Therapy for Early Stage Breast Cancer
Conditions
Breast Cancer - Early Stage
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
Breast Cancer, Partial Breast, Proton Beam
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Proton Beam Radiotherapy
Type: Radiation
Overall Status
Recruiting
Summary
The purpose of this is to determine the efficacy and toxicity of proton therapy when used to deliver partial breast radiotherapy in patients with early stage breast cancer with low or intermediate risk factors.
Detailed Description
Radiation therapy delivered to the whole breast is standard treatment following tumor removal for patients with early stage breast cancer. In selected patients, delivering the radiation treatment to only the part of the breast involved by the tumor may be a viable alternative. This can decrease the amount of normal tissues exposed to irradiation, potentially decrease side-effects and shorten the treatment time. Proton beam can decrease the volume of normal tissues treated compared to standard forms of radiotherapy. This study will recruit patients with early stage breast cancer following surgical removal to undergo partial breast radiotherapy with proton beam and determine the recurrence rates and side-effects of treatment.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 40 Years
Gender: Female
Criteria: Inclusion Criteria:
- Breast carcinoma
- DCIS
- Age 40 years or higher
- Primary tumor 3 cm or less
- Lumpectomy with clip placement
- Axillary node sampling
- Negative margins
Exclusion Criteria:
- Distant metastasis
- Multicentric disease
- Prior radiation or chemotherapy
- Active collagen vascular disease
- Pregnant or lactating
- BRCA mutation
- Lymph nodes with more than microscopic tumor involvement
- Breast carcinoma
- DCIS
- Age 40 years or higher
- Primary tumor 3 cm or less
- Lumpectomy with clip placement
- Axillary node sampling
- Negative margins
Exclusion Criteria:
- Distant metastasis
- Multicentric disease
- Prior radiation or chemotherapy
- Active collagen vascular disease
- Pregnant or lactating
- BRCA mutation
- Lymph nodes with more than microscopic tumor involvement
Locations
Loma Linda University Medical Center
Loma Linda, California, United States
Loma Linda University Medical Center / James M. Slater MD Proton Treatment Center / Department of Radiation Medicine / 11234 Anderson St.
Status: Recruiting
Contact: David A Bush, MD - 909-558-4280 - dbush@dominion.llumc.edu
Loma Linda, California, United States
Status: Recruiting
Contact: David A. Bush, MD - 909-558-4280 - dbush@dominion.llumc.edu
Start Date
May 2011
Sponsors
Loma Linda University
Source
Loma Linda University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page