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This clinical research study is to learn about the effects of giving radiotherapy alone after lumpectomy to patients who have early-stage, low-risk breast cancers and who are 60 years of age or older.
Primary Objective: To determine the 3- year DMFS rate of radiotherapy as adjuvant monotherapy for early stage, low risk breast cancers in patients aged ≥ 60 years Secondary Objectives: 1. To determine the HRQoL of patients ≥ 60 years with early stage, low risk breast cancer receiving adjuvant monotherapy with radiotherapy 2. To determine the 3-year and 5-year risk of ipsilateral breast tumor recurrence (IBTR) for early-stage breast cancers treated with lumpectomy and adjuvant radiotherapy without endocrine therapy 3. To quantify the 3-year and 5-year rates of local-regional recurrence, contralateral breast cancer, breast cancer-specific survival and overall survival and the 5 year rate of DMFS 4. To determine the 5-year utilization of salvage mastectomy and other salvage therapies 5. To determine late (up to 11 year) oncologic outcome data for patients accessible via chart review or phone call 6. To determine the toxicities experienced by patients ≥ 60 years with early stage, low risk breast cancer receiving adjuvant monotherapy with radiotherapy
Age
60 - No limit years
Sex
FEMALE
Healthy Volunteers
No
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States
Start Date
July 17, 2025
Primary Completion Date
December 31, 2028
Completion Date
December 31, 2030
Last Updated
October 30, 2025
300
ESTIMATED participants
Adjuvant Radiotherapy
RADIATION
Lead Sponsor
M.D. Anderson Cancer Center
NCT05673200
NCT05372640
Data Source & Attribution
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