Proton Therapy for Early Stage Breast Cancer

Loma Linda University50 enrolled

Overview

The purpose of this study is to determine if partial breast proton therapy is effective treatment for early stage breast cancer following lumpectomy.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Early-Stage Breast Cancer

Interventions

Proton radiation therapyRADIATION

Proton radiotherapy will start 2-4 weeks following surgical excision. The treatment area will include the lumpectomy site with an additional margin. Daily proton therapy will be given as an out-patient over a two week coarse.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Loma Linda University Medical Center / James M. Slater MD Proton Treatment Center / Department of Radiation Medicine / 11234 Anderson St.

Loma Linda, California, United States

Outcomes

Primary Outcomes

Ipsilateral Breast Tumor Recurrence-free Survival

Lack of tumor recurrence in the treated breast as assessed by imaging and physical exam

Time frame: Up to 5 years post-treatment completion, average of 48 months

Secondary Outcomes

Overall Survival

Overall survival rate at 5 years post-treatment completion.

Time frame: Up to 5 years post- completion of treatment, average 48 months

Data from ClinicalTrials.gov

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