Hypofractionated Partial Breast Irradiation in Treating Patients With Early Stage Breast Cancer
NCT03077841 · Status: SUSPENDED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 928
Last updated 2026-03-05
Summary
This phase II trial studies how well hypofractionated partial breast irradiation works in treating patients with early stage breast cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Treating only the part of the breast where the cancer started may lead to fewer side effects than standard treatment.
Conditions
- Ductal Breast Carcinoma In Situ
- Early-Stage Breast Carcinoma
- Invasive Breast Carcinoma
- Stage 0 Breast Cancer AJCC v6 and v7
- Stage I Breast Cancer AJCC v7
- Stage IA Breast Cancer AJCC v7
- Stage IB Breast Cancer AJCC v7
- Stage II Breast Cancer AJCC v6 and v7
- Stage IIA Breast Cancer AJCC v6 and v7
- Stage IIB Breast Cancer AJCC v6 and v7
Interventions
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- RADIATION
-
Partial Breast Irradiation
Undergo hypofractionated partial breast irradiation
- OTHER
-
Questionnaire Administration
Ancillary studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Benjamin D Smith · M.D. Anderson Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-03-06
- Primary Completion
- 2027-11-08
- Completion
- 2027-11-08
- FDA Drug
- Yes
Countries
- United States
Study Locations
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