This phase II trial tests how well radiation therapy (RT) without endocrine therapy (ET) works in treating older patients with stage IA-IB estrogen receptor (ER) positive breast cancer (BC). It is standard to treat early-stage, low-risk BC with lumpectomy (breast surgery), RT, and ET, but many patients choose not to receive ET because of possible side effects. The majority of BCs among women 65 years of age and older fall into a category where cancer cells tend to grow faster and are more likely to spread and come back (hormone receptor positive). RT uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. RT alone after surgery (adjuvant) without ET may have a positive impact on health-related quality of life (HRQoL). Giving RT without ET following lumpectomy may work better in treating older patients with ER positive BC.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06897488.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Simona F. Shaitelman
Phone: 832-829-0363
PRIMARY OBJECTIVE:
I. To determine the 3- year distant metastasis free survival (DMFS) rate of radiotherapy as adjuvant monotherapy for early stage, low risk breast cancers in patients aged ≥ 60 years.
SECONDARY OBJECTIVES:
I. To determine the HRQoL of patients ≥ 60 years with early stage, low risk breast cancer receiving adjuvant monotherapy with radiotherapy.
II. 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.
III. 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.
IV. To determine the 5-year utilization of salvage mastectomy and other salvage therapies.
V. To determine late (up to 11 year) oncologic outcome data for patients accessible via chart review or phone call.
VI. To determine the toxicities experienced by patients ≥ 60 years with early stage, low risk breast cancer receiving adjuvant monotherapy with radiotherapy.
EXPLORATORY OBJECTIVES:
I. To quantify the detection of circulating tumor deoxyribonucleic acid (DNA) (ctDNA) in a cohort of patients who omit adjuvant endocrine therapy following lumpectomy.
OUTLINE:
Within 16 weeks of the final breast surgery, patients undergo RT at the discretion of the treating radiation oncologist and in the absence of disease progression or unacceptable toxicity. Patients also may undergo blood sample collection throughout the study.
After completion of study treatment, patients are followed up at 6 months and annually from years 1.5 to 10.5.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorSimona F. Shaitelman
