Know Cancer

or
forgot password

Phase 2 Trial of Partial Breast Proton Therapy for Early Stage Breast Cancer With Low and Intermediate Risk Factors.


Phase 2
40 Years
80 Years
Open (Enrolling)
Female
Breast Cancer, Early Stage

Thank you

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 CenterLoma 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