Phase 2 Trial of Partial Breast Proton Therapy for Early Stage Breast Cancer With Low and Intermediate Risk Factors.
40 Years
80 Years
Female
Breast Cancer, Early Stage
Trial Information
Phase 2 Trial of Partial Breast Proton Therapy for Early Stage Breast Cancer With Low and Intermediate Risk Factors.
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Rate of recurrence in the breast
Outcome Time Frame:
5 years
Safety Issue:
No
Principal Investigator
David A Bush, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Radiation Medicine - Loma Linda University Medical Center
Authority:
United States: Institutional Review Board
Study ID:
OSR #5110026
NCT ID:
NCT01310530
Start Date:
May 2011
Completion Date:
Related Keywords:
- Breast Cancer
- Early Stage
- Breast Cancer
- Partial Breast
- Proton Beam
- Breast Neoplasms
Name | Location |
|---|---|
| Loma Linda University Medical Center | Loma Linda, California 92354 |
| Loma Linda University Medical Center / James M. Slater MD Proton Treatment Center / Department of Radiation Medicine / 11234 Anderson St. | Loma Linda, California 92354 |
