Proton Beam Radiation Therapy or Photon Beam Radiation Therapy in Treating Patients with Non-Metastatic Breast Cancer

Status: Active

Description

This randomized phase III trial studies proton beam radiation therapy (proton therapy) compared to photon beam radiation therapy (photon therapy) in treating patients with breast cancer that has not spread to other places in the body (non-metastatic). Radiation therapy is an important treatment for breast cancer, however, radiation goes to other organs, such as heart, causing heart problems. Proton therapy is a type of radiation therapy that uses multiple beams of protons (tiny particles with a positive charge) to kill tumor cells without damaging normal tissue. Photon therapy is also a type of radiation therapy that uses multiple x-ray beams. The radiation dose is delivered at the surface of the body and goes into the tumor and through the body which may damage normal tissue. It is not yet known whether proton therapy is more effective than photon therapy in treating patients with non-metastatic breast cancer without causing heart damage.

Eligibility Criteria

Inclusion Criteria

  • Patients must have the psychological ability and general health that permits informed consent, completion of the study requirements, and required follow up
  • Diagnosed with pathologically (histologically) proven invasive mammary carcinoma (ductal, lobular or other) of the breast who have undergone either mastectomy or lumpectomy with any type of axillary surgery or axillary sampling
  • For patients who have undergone mastectomy, any type of mastectomy and any type of reconstruction (including no reconstruction) are allowed; metallic components of some tissue expanders may complicate delivery of proton therapy; any concerns should be discussed with the Breast Committee Study Chairs prior to registration
  • For patients who have undergone lumpectomy, there are no breast size limitations
  • Patients with non-metastatic breast cancer are eligible; this includes American Joint Committee on Cancer (AJCC) 7th edition left- or right-sided breast cancer clinical or pathologic stage I, II, III or loco-regionally recurrent at time of diagnosis; for patients that receive neoadjuvant chemotherapy, AJCC 7th edition left- or right-sided breast cancer pathologic stage yp 0, I, II, III are eligible
  • Bilateral breast cancer is permitted; patients with bilateral breast cancer will be stratified as left-sided
  • Must be proceeding with breast/chest wall and nodal radiation therapy including internal mammary node treatment
  • Must have a pertinent history/physical examination within 90 days prior to registration
  • Negative pregnancy test by urine or serum or waiver of pregnancy testing per local institutional policy within 30 days prior to randomization according to local standards for women of childbearing potential
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 – 2 (asymptomatic to symptomatic but capable of self-care) within 45 days prior to randomization
  • Confirmation that the patient’s health insurance will pay for the treatment in this study (patients may still be responsible for some costs, such as co-pays and deductibles); if the patient’s insurance will not cover a specific treatment in this study and the patient still wants to participate, confirmation that the patient would be responsible for paying for any treatment received
  • Patients who are human immunodeficiency virus (HIV) positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a cluster of differentiation (CD)4 count >= 200 cells/microliter within 180 days prior to registration as documented in the medical record; HIV testing is not required for eligibility for this protocol
  • The patient must provide study-specific informed consent prior to study entry

Exclusion Criteria

  • Definitive clinical or radiologic evidence of metastatic disease, as documented by the treating institution
  • Prior radiotherapy to the ipsilateral chest wall or ipsilateral breast or thorax; individuals with prior radiotherapy in the contralateral breast or chest wall are eligible
  • Any radiation therapy for the currently diagnosed breast cancer prior to randomization
  • Dermatomyositis with a creatine phosphokinase (CPK) level above normal or with an active skin rash or scleroderma
  • Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up

Locations & Contacts

Arizona

Phoenix
Mayo Clinic Hospital
Status: Active
Contact: Sameer Ramchandra Keole
Phone: 480-342-1262
Email: Keole.sameer@mayo.edu

California

La Jolla
UC San Diego Moores Cancer Center
Status: Active
Contact: James John Urbanic
Phone: 858-246-0500
Email: jurbanic@ucsd.edu

Florida

Gainesville
University of Florida Health Science Center - Gainesville
Status: Active
Contact: Julie A. Bradley
Email: jbradley@floridaproton.org
Jacksonville
University of Florida Proton Therapy Institute
Status: Active
Contact: Julie A. Bradley
Phone: 904-588-1800
Email: jbradley@floridaproton.org
Miami
Miami Cancer Institute
Status: Active
Contact: Marcio Augusto Fagundes
Email: marciof@baptisthealth.net
Orlando
UF Cancer Center at Orlando Health
Status: Active
Contact: Tomas Dvorak
Phone: 321-841-8650
Email: Tomas.Dvorak@orlandohealth.com

Illinois

DeKalb
Northwestern Medicine Cancer Center Kishwaukee
Status: Active
Contact: Christy M. Kesslering
Phone: 630-821-6400
Email: ckesslering@chicagocancer.org
Geneva
Northwestern Medicine Cancer Center Delnor
Status: Active
Contact: Christy M. Kesslering
Phone: 630-821-6400
Email: ckesslering@chicagocancer.org
Warrenville
Northwestern Medicine Cancer Center Warrenville
Status: Active
Contact: Christy M. Kesslering
Phone: 630-821-6400
Email: ckesslering@chicagocancer.org
Northwestern Medicine Chicago Proton Center
Status: Active
Contact: Christy M. Kesslering
Phone: 630-821-6400
Email: ckesslering@chicagocancer.org

Louisiana

Shreveport
Willis-Knighton Medical and Cancer Center
Status: Active
Contact: Lane R. Rosen
Phone: 318-212-4639
Email: lrosen@wkhs.com

Maryland

Baltimore
Maryland Proton Treatment Center
Status: Active
Contact: Mark V. Mishra
Phone: 410-328-2328
Email: mmishra@umm.edu
University of Maryland / Greenebaum Cancer Center
Status: Active
Contact: Mark V. Mishra
Phone: 410-328-2328
Email: mmishra@umm.edu
Bel Air
UM Upper Chesapeake Medical Center
Status: Active
Contact: Neha Pradip Amin
Email: Neha.Amin@umm.edu
Columbia
Central Maryland Radiation Oncology in Howard County
Status: Active
Contact: Mark V. Mishra
Phone: 410-328-2328
Email: mmishra@umm.edu
Glen Burnie
UM Baltimore Washington Medical Center / Tate Cancer Center
Status: Active
Contact: Wendla Karen Citron
Email: mmishra@umm.edu

Massachusetts

Boston
Massachusetts General Hospital Cancer Center
Status: Active
Contact: Shannon Michelle MacDonald
Phone: 617-643-7250
Email: SMacDonald@mgh.harvard.edu
Danvers
Mass General / North Shore Cancer Center
Status: Active
Contact: James Francis McIntyre
Email: jfmcintyre@partners.org

Michigan

Royal Oak
William Beaumont Hospital-Royal Oak
Status: Active
Contact: Peter Y. Chen
Email: Peter.Chen@beaumont.edu

Minnesota

Rochester
Mayo Clinic
Status: Active
Contact: Robert W. Mutter
Phone: 507-284-2511
Email: Mutter.robert@mayo.edu

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: Active
Contact: Imran Zoberi
Phone: 314-747-7236
Email: izoberi@radonc.wustl.edu

New Jersey

New Brunswick
Rutgers Cancer Institute of New Jersey
Status: Active
Contact: Bruce George Haffty
Phone: 732-253-3939
Email: hafftyb@cinj.rutgers.edu
Somerset
ProCure Proton Therapy Center-Somerset
Status: Active
Contact: Henry K. Tsai
Email: htsai@prapa.com

New York

New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Oren Cahlon
Phone: 212-639-5219
Email: cahlono@mskcc.org

Ohio

Beachwood
UHHS-Chagrin Highlands Medical Center
Status: Active
Contact: Janice Lyons
Email: Janice.Lyons@uhhospitals.org
Cincinnati
Holmes Hospital University of Cincinnati
Status: Active
Contact: Teresa Meier
Email: meierta@ucmail.uc.edu
University of Cincinnati / Barrett Cancer Center
Status: Active
Contact: Teresa Meier
Email: meierta@ucmail.uc.edu
Cleveland
Case Western Reserve University
Status: Active
Contact: Janice Lyons
Email: Janice.Lyons@uhhospitals.org
Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Status: Active
Contact: Janice Lyons
Phone: 216-896-1755
Email: Janice.lyons@uhhospitals.org

Oklahoma

Oklahoma City
ProCure Proton Therapy Center-Oklahoma
Status: Active
Contact: Kiran Prabhu
Phone: 888-847-2640
Email: prabhx@gmail.com

Pennsylvania

Harrisburg
UPMC Pinnacle Cancer Center / Community Osteopathic Campus
Status: Active
Contact: David C. Weksberg
Email: klitchfield@PINNACLEHEALTH.org
Philadelphia
Pennsylvania Hospital
Status: Active
Contact: Gary Mitchel Freedman
Email: Gary.Freedman@uphs.upenn.edu
University of Pennsylvania / Abramson Cancer Center
Status: Active
Contact: Gary Mitchel Freedman
Email: Gary.Freedman@uphs.upenn.edu
West Chester
Chester County Hospital
Status: Active
Contact: Andre A. Konski
Email: DrAndre.Konski@uphs.upenn.edu

Tennessee

Knoxville
Provision Center for Proton Therapy
Status: Active
Contact: Allen George Meek
Phone: 865-202-0405
Email: Allen.Meeks@provisionproton.com

Texas

Houston
M D Anderson Cancer Center
Status: Active
Contact: Karen E. Hoffman
Phone: 713-792-2121
Email: KHoffman1@mdanderson.org
Irving
Texas Center for Proton Therapy
Status: Active
Contact: Jared D. Sturgeon
Phone: 469-513-5500
Email: Jared.sturgeon@usoncology.com

Washington

Seattle
Seattle Cancer Care Alliance
Status: Active
Contact: Li-Ming Christine Fang
Email: lmcfang@uw.edu
University of Washington Medical Center
Status: Active
Contact: Li-Ming Christine Fang
Phone: 206-598-4100
Email: lmcfang@uw.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To assess the effectiveness of proton versus (vs.) photon therapy in reducing major cardiovascular events (MCE), defined as atherosclerotic coronary heart disease or other heart disease death, myocardial infarction, coronary revascularization, or hospitalization for major cardiovascular event (heart failure, valvular disease, arrhythmia, or unstable angina).

SECONDARY OBJECTIVES:

I. To assess the non-inferiority of proton vs. photon therapy in reducing ipsilateral breast cancer local-regional recurrence and in reducing any recurrence, defined as the first reported breast cancer recurrence of any type (local-regional or distant or cancer-specific mortality).

II. To assess the effectiveness of proton vs. photon therapy in improving patient-reported body image and function, fatigue and other measures of health-related quality of life (HRQOL) (anxiety, social roles, financial toxicity, general satisfaction) and adverse events.

III. To develop predictive models to examine the association of radiation dose distribution (to heart and other normal tissues) and MCE and HRQOL outcomes.

IV. To assess longer-term rates of breast cancer specific and overall survival and development of second malignancies.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo photon beam radiation therapy for 5 to 7 weeks with or without a tumor bed boost within 12 weeks of breast cancer surgery. Treatment continues in the absence of disease progression or unacceptable toxicity.

ARM II: Patients undergo image-guided proton beam radiation therapy for 5 to 7 weeks with or without a tumor bed boost within 12 weeks of breast cancer surgery. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1, 6, and 12 months and then every 6-12 months thereafter.

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
University of Pennsylvania / Abramson Cancer Center

Principal Investigator
Gary Mitchel Freedman

Trial IDs

Primary ID UPCC 19115
Secondary IDs NCI-2015-01950, 823440, UPC 19115
Clinicaltrials.gov ID NCT02603341