This phase II trial tests whether giving radiation once a day for 15 treatments after repeat breast conserving surgery works as well as giving it the regular way in patients with breast cancer that has come back in the same side after a period of improvement (ipsilateral recurrence). The usual approach for treating this type of cancer is radiation given twice daily (separated by at least 6 hours) for a total of 30 treatments. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. This study may help researchers learn how using daily partial radiation therapy may be better treatment option than the usual care with twice daily radiation treatments, resulting in less visits, which may mean less inconvenience for treatment in patients with recurrent ipsilateral breast cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06129747.
Locations matching your search criteria
United States
Ohio
Cleveland
Case Comprehensive Cancer CenterStatus: Active
Contact: Janice Lyons
Phone: 216-844-2514
PRIMARY OBJECTIVE:
I. To determine the rate of grade 3+ treatment-related skin, fibrosis, and breast pain adverse events that occurred within 1 year from the completion of reirradiation.
SECONDARY OBJECTIVES:
I. To determine the overall in-breast tumor recurrence.
II. To determine the freedom from mastectomy rate.
III. To determine the all treatment-related adverse events for the following time periods:
IIIa. After 1 year from completion of re-irradiation;
IIIb. Overall.
IV. To determine cosmesis (evaluated at 1 and 3 years).
V. To determine overall survival (failure: death due to any cause).
VI. To determine mastectomy-free survival (failure: mastectomy of the treated breast or death due to any cause).
OUTLINE:
Patients undergo radiation therapy for 15 fractions over 30 minutes once daily (QD) 5 days per week. Treatment continues for 3 weeks in the absence of disease progression or unacceptable toxicity. Patients with high risk features may receive a simultaneous boost over 15 fractions. Patients undergo computed tomography (CT) scan and bone scan or positron emission tomography (PET) scan during screening.
After completion of study treatment, patients are followed up at 30 days, 3 months, 6 months, 1 year, and yearly for 3 years.
Lead OrganizationCase Comprehensive Cancer Center
Principal InvestigatorJanice Lyons