Partial Breast Proton Therapy for Early Stage Breast Cancer
Phase 2 Trial of Partial Breast Proton Therapy for Early Stage Breast Cancer With Low and Intermediate Risk Factors.
1 other identifier
interventional
150
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started May 2011
Longer than P75 for not_applicable breast-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2011
CompletedFirst Posted
Study publicly available on registry
March 8, 2011
CompletedStudy Start
First participant enrolled
May 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
February 4, 2026
February 1, 2026
15.6 years
March 7, 2011
February 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of recurrence in the breast
5 years
Secondary Outcomes (3)
Rate of breast recurrence of low versus intermediate risk patients
5 years
Side-effects related to treatment
5 years
Disease Free Survival
5 years
Study Arms (1)
Partial Breast Proton Therapy
EXPERIMENTALTwo weeks of daily proton therapy delivered to the lumpectomy site.
Interventions
Daily proton beam radiotherapy is delivered to the site of the breast tumor in ten treatment sessions over two week as an outpatient.
Eligibility Criteria
You may qualify if:
- Breast carcinoma
- DCIS
- Age 40 years or higher
- Primary tumor 3 cm or less
- Lumpectomy with clip placement
- Axillary node sampling
- Negative margins
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Loma Linda University Medical Center / James M. Slater MD Proton Treatment Center / Department of Radiation Medicine / 11234 Anderson St.
Loma Linda, California, 92354, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Related Publications (1)
Bush DA, Slater JD, Garberoglio C, Yuh G, Hocko JM, Slater JM. A technique of partial breast irradiation utilizing proton beam radiotherapy: comparison with conformal x-ray therapy. Cancer J. 2007 Mar-Apr;13(2):114-8. doi: 10.1097/PPO.0b013e318046354b.
PMID: 17476139BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David A Bush, MD
Radiation Medicine - Loma Linda University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2011
First Posted
March 8, 2011
Study Start
May 4, 2011
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
February 4, 2026
Record last verified: 2026-02