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Proton Therapy for Peripheral Lymph Nodes in Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Proton Therapy for Peripheral Lymph Nodes in Breast Cancer

Inclusion Criteria:

- Pathologically confirmed invasive adenocarcinoma of the breast stage I-III (TX, T0-4,
N0-3) with medially located tumor and/or axillary node invasion.

- Patients must have undergone either mastectomy or breast conservation surgery.

- Patients are required to have axillary staging which can include sentinel node biopsy
alone if sentinel node is negative.

- Patient must require peripheral lymph node radiation per physician discretion.

Exclusion Criteria:

- Evidence of distant metastasis (M1).

- Prior radiotherapy to the area of interest.

- Prior history of cardiovascular disease per physician discretion.

- Prior or concurrent cancer other than non-melanomatous skin cancer unless disease
free for at least 5 years.

- Collagen vascular disease, specifically dermatomyositis with a CPK level above normal
or with an active skin rash, systemic lupus erythematosis or scleroderma.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Collection and Analyzation of Dosimetric Information

Outcome Description:

Determine whether proton therapy will reduce the volume of heart exposed to radiation doses ≥ 5 Gy/Cobalt Gray Equivalent by at least 50% compared with conventional planning.

Outcome Time Frame:

2 weeks prior to starting radiation therapy.

Safety Issue:


Principal Investigator

Julie A Bradley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Florida Proton Therapy Institute


United States: Institutional Review Board

Study ID:

UFPTI 1016-BR01



Start Date:

May 2012

Completion Date:

January 2019

Related Keywords:

  • Breast Cancer
  • Proton Radiation
  • Breast Cancer
  • Breast Neoplasms



University of Florida Proton Therapy InstituteJacksonville, Florida  32206