N/A
N=50
Proton Therapy for Early Stage Breast Cancer
Early-Stage Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00614172 ↗Enrolled (actual)
50
Serious AEs
98.0%
Results posted
Sep 2023
Primary outcome: Primary: Ipsilateral Breast Tumor Recurrence-free Survival — 92 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Proton radiation therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Loma Linda University
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ipsilateral Breast Tumor Recurrence-free Survival |
92 | — |
| SECONDARY Overall Survival |
96 | — |
Summary
The purpose of this study is to determine if partial breast proton therapy is effective treatment for early stage breast cancer following lumpectomy.
Eligibility Criteria
Inclusion Criteria
- Invasive ductal, medullary, papillary, colloid or tubular histologies
- Stages T1 or T2 (tumors 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
Data sourced from ClinicalTrials.gov (NCT00614172). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.