Phase II Trial of Lumpectomy and Partial Breast Proton Therapy for Early Stage Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Early-Stage Breast Cancer
- Sponsor
- Loma Linda University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Ipsilateral Breast Tumor Recurrence-free Survival
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to determine if partial breast proton therapy is effective treatment for early stage breast cancer following lumpectomy.
Detailed Description
Radiation therapy is considered standard treatment for most women with early stage breast cancer following lumpectomy. Post-lumpectomy radiotherapy is a proven treatment that reduces cancer recurrence in the breast and improves survival. When standard whole breast radiation techniques are utilized, portions of the chest wall, lung and heart may also receive significant doses of radiation which can lead to radiation induced complications. Radiation techniques that limit the treatment area to the portion of the breast where the cancer arose can minimize and even eliminate radiation dose to the chest wall, heart and lung. This is called partial breast radiotherapy. This study is designed to evaluate the use of proton beam radiotherapy to deliver partial breast radiotherapy in women with early stage breast cancer.
Investigators
David Bush
Principal Inverstigator
Loma Linda University
Eligibility Criteria
Inclusion Criteria
- •Invasive ductal, medullary, papillary, colloid or tubular histologies
- •Stages T1 or T2 (tumors \< or = 3 cm) from lumpectomy specimen.
- •No more then 3 positive nodes on axillary dissection or negative sentinel node.
- •Negative surgical margins (\>2mm)
Exclusion Criteria
- •Invasive lobular histology
- •Previous chemotherapy for breast cancer
- •Extensive intraductal component
- •Collagen vascular disease
- •Prior malignancy unless disease-free for 5 years
- •Patients who are pregnant or lactating
Outcomes
Primary Outcomes
Ipsilateral Breast Tumor Recurrence-free Survival
Time Frame: Up to 5 years post-treatment completion, average of 48 months
Lack of tumor recurrence in the treated breast as assessed by imaging and physical exam
Secondary Outcomes
- Overall Survival(Up to 5 years post- completion of treatment, average 48 months)