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Proton Beam Radiation Therapy or Photon Beam Radiation Therapy in Treating Patients with Non-Metastatic Breast Cancer, A Radiotherapy Comparative Effectiveness (RadComp) Consortium Trial

Status
Active
Cancer Type
Breast Cancer
Trial Phase
Phase III
Eligibility
21 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT02603341
Protocol IDs
UPCC 19115 (primary)
UPC 19115
NCI-2015-01950
823440
Study Sponsor
University of Pennsylvania/Abramson Cancer Center

Summary

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. Photon therapy is also a type of radiation therapy which uses multiple x-ray beams to kill tumor cells. Proton therapy is theorized to deposit less radiation to healthy tissues beyond the cancer tumor. However, 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.

Objectives

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.

Eligibility

  1. Patients must have the psychological ability and general health that permits informed consent, completion of the study requirements, and required follow up
  2. 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
  3. 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
  4. For patients who have undergone lumpectomy, there are no breast size limitations
  5. 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
  6. Bilateral breast cancer is permitted; patients with bilateral breast cancer will be stratified as left-sided
  7. Must be proceeding with breast/chest wall and nodal radiation therapy including internal mammary node treatment
  8. Must have a pertinent history/physical examination within 90 days prior to registration
  9. 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
  10. Eastern Cooperative Oncology Group (ECOG) performance status 0 – 2 (asymptomatic to symptomatic but capable of self-care) within 45 days prior to randomization
  11. 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
  12. 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
  13. The patient must provide study-specific informed consent prior to study entry

Treatment Sites in Georgia

Emory University Hospital - Atlanta


1364 Clifton Road NE
Atlanta, GA 30322
www.emoryhealthcare.org

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