Proton Therapy for Early Stage Breast Cancer

Not Applicable

Completed

• Conditions: Early-Stage Breast Cancer
• Interventions: Radiation: Proton radiation therapy

• Registration Number: NCT00614172
• Lead Sponsor: Loma Linda University

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.

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2007-12-26
• Study First Submitted QC: 2008-01-29
• Study First Posted: 2008-02-13
• Primary Completion: 2020-05-12
• Study Completion: 2020-05-12
• Status Verified: 2023-08
• Results First Submitted: 2023-08-03
• Results First Submitted QC: 2023-08-24
• Last Update Submitted: 2023-08-24
• Results First Posted: 2023-09-21
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Proton Radiotherapy	Proton radiation therapy	Two week course of proton radiotherapy to the breast.

Primary Outcome Measures

Name	Time	Method
Ipsilateral Breast Tumor Recurrence-free Survival	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 Outcome Measures

Name	Time	Method
Overall Survival	Up to 5 years post- completion of treatment, average 48 months	Overall survival rate at 5 years post-treatment completion.

Trial Locations

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