Partial Breast Proton Therapy for Early Stage Breast Cancer

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Radiation: Proton Beam Radiotherapy

• Registration Number: NCT01310530
• Lead Sponsor: Loma Linda University

Brief 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.

Study Timeline

• Study First Submitted: 2011-03-07
• Study First Submitted QC: 2011-03-07
• Study First Posted: 2011-03-08
• Study Start: 2011-05-04
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-14
• Last Update Posted: 2024-06-17
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Partial Breast Proton Therapy	Proton Beam Radiotherapy	Two weeks of daily proton therapy delivered to the lumpectomy site.

Primary Outcome Measures

Name	Time	Method
Rate of recurrence in the breast	5 years

Secondary Outcome Measures

Name	Time	Method
Side-effects related to treatment	5 years
Rate of breast recurrence of low versus intermediate risk patients	5 years
Disease Free Survival	5 years

Trial Locations

Locations (2)

Loma Linda University Medical Center / James M. Slater MD Proton Treatment Center / Department of Radiation Medicine / 11234 Anderson St.; 🇺🇸 Loma Linda, California, United States

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States