Purpose

The purpose of this study is to compare the effects on low risk breast cancer receiving usual care that includes regional radiation therapy, with receiving no regional radiation therapy. Researchers want to see if not giving this type of radiation treatment works as well at preventing breast cancer from coming back.

Category

IRB Number
20180650HU
NCT Number
NCT03488693
Open to Enrollment
Yes
Sponsor
Canadian Cancer Trials Group -



Study Contact

Principal Investigator
Chul Ha

Regulatory Point of Contact
Frances Crawford
(210) 450-5037
crawfordf1@uthscsa.edu

Regulatory Point of Contact
Sonia Creighton
(210) 450-1366
creighton@uthscsa.edu

Regulatory Point of Contact
Chul Ha
(210) 450-5566
hac@uthscsa.edu

Regulatory Point of Contact
Myrna Montenegro
(210) 450-5954
montenegro@uthscsa.edu

Regulatory Point of Contact
Mailbox Ctrc Regulatory Affairs
regaffapp@uthscsa.edu

Regulatory Point of Contact
Regulatory Staff
regaffstaff@uthscsa.edu

Regulatory Point of Contact
Kathleen Rodriguez
(210) 450-1365
rodriguezk3@uthscsa.edu

Regulatory Point of Contact
Benjamin Schleif
(210) 450-1366
schleifb@uthscsa.edu

Regulatory Point of Contact
Morgan Seekatz
(210) 450-1133
seekatz@uthscsa.edu



Eligibility

Eligible Ages
Over 35 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

    Exclusion Criteria


      Study Design

      Phase
      N/A
      Study Type
      Interventional
      Allocation
      Randomized
      Intervention Model
      Parallel Assignment
      Primary Purpose
      Treatment
      Masking
      None (Open Label)
      Condition
    1. Breast Cancer
    2. Arm Groups

      ArmDescriptionIntervention
      Active Comparator

      No Regional Radiotherapy

      A. Whole Breast Irradiation (WBI) following BCS or; B. No Radiotherapy (RT) following mastectomy
    3. Radiation: Radiation

      Radiotherapy given

    4. Other: No Radiation

      No radiotherapy given

    5. Active Comparator

      Regional Radiotherapy

      A. WBI plus RT to the regional nodes (supraclavicular, non-dissected axillary, and internal mammary) following BCS or; B. RT to the chestwall and regional nodes (supraclavicular, non-dissected axillary, and internal mammary) following mastectomy
    6. Radiation: Radiation

      Radiotherapy given

    7. Other: No Radiation

      No radiotherapy given