← Back to Search

Proton Beam Therapy

Proton Therapy for Early Stage Breast Cancer

N/A

Waitlist Available

Led By David A Bush, MD

Research Sponsored by Loma Linda University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 40 years or higher

Breast carcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial is testing whether proton therapy is an effective and safe treatment for early stage breast cancer.

Who is the study for?

This trial is for women aged 40 or older with early stage breast cancer that's low or intermediate risk. The tumor must be no larger than 3 cm, and they should have had a lumpectomy with clip placement and axillary node sampling showing negative margins. Women can't join if they are pregnant, breastfeeding, have certain genetic mutations like BRCA, active collagen vascular disease, distant spread of cancer (metastasis), more than one center of cancer in the same breast (multicentric disease), or previous radiation/chemotherapy.Check my eligibility

What is being tested?

The trial is testing how effective and safe proton beam radiotherapy is when used as partial breast treatment in patients with early stage breast cancer. Proton therapy is a type of radiation that targets tumors more precisely to minimize damage to surrounding healthy tissue.See study design

What are the potential side effects?

Proton beam radiotherapy may cause skin redness and irritation at the treatment site, fatigue, changes in skin coloration or texture around the treated area, swelling due to fluid buildup (lymphedema), and less commonly could lead to heart problems or secondary cancers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 40 years old or older.

Select...

I have been diagnosed with breast cancer.

Select...

My primary tumor is 3 cm or smaller.

Select...

I had a lumpectomy with a clip placed in my breast.

Select...

I have had a biopsy of the lymph nodes under my arm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of recurrence in the breast

Secondary outcome measures

Disease Free Survival

Rate of breast recurrence of low versus intermediate risk patients

Side-effects related to treatment

Trial Design

1Treatment groups

Experimental Treatment

Group I: Partial Breast Proton TherapyExperimental Treatment1 Intervention

Two weeks of daily proton therapy delivered to the lumpectomy site.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Proton Beam Radiotherapy

2009

N/A

~70

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Loma Linda UniversityLead Sponsor

306 Previous Clinical Trials

260,838 Total Patients Enrolled

3 Trials studying Breast Cancer

96,074 Patients Enrolled for Breast Cancer

David A Bush, MDPrincipal InvestigatorRadiation Medicine - Loma Linda University Medical Center

1 Previous Clinical Trials

76 Total Patients Enrolled

Media Library

Breast Cancer Research Study Groups: Partial Breast Proton Therapy

Breast Cancer Clinical Trial 2023: Proton Beam Radiotherapy Highlights & Side Effects. Trial Name: NCT01310530 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available for people seeking to join this experiment?

"This trial, originally shared on May 4th 2011 and last updated on the 26th of May 2022 is currently not recruiting patients. Nonetheless, there are over 2600 other trails actively enrolling participants at present."

Answered by AI

Who is the ideal candidate for this research endeavor?

"In order to partake in this trial, individuals should have been diagnosed with breast cancer and be between 40-80 years old. At the moment, approximately 150 people are needed for participation."

Answered by AI

Is this research program targeting individuals older than 40 years of age?

"According to the given inclusion criteria, only individuals between 40 and 80 can join this medical trial. There are 74 trials available for people under 18 years old whereas 2506 studies exist for those over 65."

Answered by AI

Recent research and studies

The Cancer JournalJournal

A Technique of Partial Breast Irradiation Utilizing Proton Beam Radiotherapy: Comparison with Conformal X-ray Therapy

Bush, David A., Jerry D. Slater, Carlos Garberoglio, Grace Yuh, Janet M. Hocko, and James M. Slater. 2007. “A Technique of Partial Breast Irradiation Utilizing Proton Beam Radiotherapy: Comparison with Conformal X-ray Therapy”. The Cancer Journal. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/ppo.0b013e318046354b.

clinicaltrials.govStudy

Partial Breast Proton Therapy for Early Stage Breast Cancer

2011. "Partial Breast Proton Therapy for Early Stage Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01310530.