This trial is active, not recruiting.

Condition breast cancer
Treatments photon, 3d-proton/conventional plan or 3d-proton only
Phase phase 2
Sponsor University of Florida
Start date April 2012
End date March 2014
Trial size 18 participants
Trial identifier NCT01365845, UFPTI 1016-BR01


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Conventional photon plan
50.4 Gy to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction
3D-Proton/Conventional plan or 3D-proton only
3d-proton/conventional plan or 3d-proton only
50.4 Cobalt Gray Equivalent/Gray to the breast/chest wall and peripheral lymph nodes at 1.8 Cobalt Gray Equivalent/Gray per fraction

Primary Outcomes

Volume of Heart Receiving ≥ 5 Gray (Gy)/Cobalt Gray Equivalent (CGE)
time frame: 2 weeks prior to starting radiation therapy.

Secondary Outcomes

Secondary Dosimetric Endpoint
time frame: 2 weeks prior to starting radiation therapy.
Assessment of Acute Side Effects
time frame: Participants will be assessed weekly during radiation therapy for an expected average of 7 weeks.
Assessment of Longterm Side Effects and Disease Specific End Points.
time frame: 1 month following completion of treatment, then every 6 months for 5 years, then annually thereafter.
Assessment of Cardiac Function Markers
time frame: after treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Proton Therapy for Peripheral Lymph Nodes in Breast Cancer
Principal investigator Julie A Bradley, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University of Florida.