Purpose

This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. Radiation therapy uses high-energy x rays to kill tumor cells. It is not yet known whether comprehensive radiation therapy is more effective than standard radiation therapy in treating patients with breast cancer

Category

IRB Number
20150021HU
NCT Number
NCT01872975
Open to Enrollment
Yes
Sponsor
NSABP Foundation Inc -



Study Contact

Principal Investigator
Chul Ha

Frances Crawford
(210) 450-5037
crawfordf1@uthscsa.edu

Sonia Creighton
(210) 450-1366
creighton@uthscsa.edu

Patricia Devore
(210) 450-1233
devore@uthscsa.edu

Chul Ha
(210) 450-5566
hac@uthscsa.edu

Myrna Montenegro
(210) 450-5954
montenegro@uthscsa.edu

Courtney Nichols
(210) 450-1794
nicholsc2@uthscsa.edu

Mailbox Ctrc Regulatory Affairs
regaffapp@uthscsa.edu

Regulatory Staff
regaffstaff@uthscsa.edu

Kathleen Rodriguez
(210) 450-1365
rodriguezk3@uthscsa.edu

Benjamin Schleif
(210) 450-1366
schleifb@uthscsa.edu

Morgan Seekatz
(210) 450-1133
seekatz@uthscsa.edu



Eligibility

Eligible Ages
Over 18 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. Stage IB Breast Cancer
    2. Stage II Breast Cancer

      3. Arm Groups

      ArmDescriptionIntervention
      Active Comparator

      Group 1A Lumpectomy: no regional nodal XRT with WBI

      		Lumpectomy patients undergo whole breast radiation therapy using IMRT or 3D-CRT once daily 5 days a week for 5 weeks followed by a radiation therapy boost to the lumpectomy cavity once daily 5 days a week for 1-1/2 weeks.
    3. Radiation: WBI

      Other names:

      • Whole Breast Irradiation (WBI)

      4. Experimental

      Group 2A lumpectomy: Regional nodal XRT with WBI

      		Lumpectomy patients undergo regional nodal radiation therapy with whole breast radiation therapy using IMRT or 3D-CRT once daily 5 days a week for 5 weeks followed by a radiation therapy boost to the lumpectomy cavity once daily 5 days a week for 1-1/2 weeks.
    4. Radiation: regional nodal XRT

      Other names:

      • XRT: External radiotherapy

    5. Radiation: WBI

      Other names:

      • Whole Breast Irradiation (WBI)

      6. No Intervention

      Group 1B Mastectomy: No regional nodal or chestwall XRT

      		Mastectomy patients do not undergo radiation therapy.
      Experimental

      Group 2B Mastectomy: Regional nodal XRT and chestwall XRT

      		Mastectomy patients undergo regional nodal radiation therapy using IMRT or 3D-CRT once daily 5 days a week for 5 weeks.
    6. Radiation: regional nodal XRT

      Other names:

      • XRT: External radiotherapy

    7. Radiation: chestwall XRT

      Other names:

      • XRT: External radiotherapy

      8.