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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
Must not have
Lymph nodes with more than microscopic tumor involvement
Distant metastasis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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
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I am 40 years old or older.
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I have been diagnosed with breast cancer.
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My primary tumor is 3 cm or smaller.
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I had a lumpectomy with a clip placed in my breast.
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I have had a biopsy of the lymph nodes under my arm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread to my lymph nodes beyond a microscopic level.
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My cancer has spread to distant parts of my body.
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My cancer is present in multiple locations within the same organ.
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I have had radiation or chemotherapy before.
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I have a BRCA gene mutation.
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I have an active connective tissue disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active 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
~80

Find a Location

Who is running the clinical trial?

Loma Linda UniversityLead Sponsor
315 Previous Clinical Trials
266,440 Total Patients Enrolled
2 Trials studying Breast Cancer
49 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
~4 spots leftby May 2025
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