Proton Therapy for Lymph Nodes in Breast Cancer (BR01)

University of Florida

Status

Completed

Conditions

Breast Cancer

Treatments

Radiation: 3D-Proton/Conventional plan or 3D-proton only

Radiation: Photon

Study type

Interventional

Funder types

Other

Identifiers

NCT01365845

UFPTI 1016-BR01 (Other Identifier)

IRB201701740

Details and patient eligibility

About

The purpose of this study is to determine if proton radiation therapy will reduce the amount of heart that is exposed to radiation, thereby decreasing the frequency and/or severity of any cardiac side effects.

Enrollment

18 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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.