This phase III trial compares the effect of adding pre-operative endocrine therapy to lumpectomy to surgery alone in determining treatment with post-operative radiation therapy in older women with early stage estrogen receptor positive (ER+) breast cancer. Historically, women over 65 with early-stage ER+ breast cancer are treated with surgery to remove the mass (lumpectomy) with or without radiation followed by endocrine therapy. Endocrine therapy lowers the amount of estrogen made by the body or blocks the use of estrogen by the tumor cells. This may help stop the growth of tumor cells that need estrogen to grow. Radiation therapy can be used after surgery to treat early-stage breast cancer and uses high-energy rays to kill cancer cells. Current guidelines indicate radiation is not necessary for in women 65 or older with early stage ER+ breast cancer taking endocrine therapy after surgery. However, if a patient does not get radiation therapy and is unable to take the prescribed number of years of endocrine therapy, the risk of recurrence increases. Alternatively, radiation therapy may not be needed if endocrine therapy is tolerable. Pre-operative endocrine therapy with lumpectomy may be effective in determining treatment with post-operative radiation therapy in older women with early stage ER+ breast cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT06507618.
Locations matching your search criteria
United States
Virginia
Charlottesville
University of Virginia Cancer CenterStatus: Active
Contact: Trish Millard
Phone: 434-982-3210
Culpeper
Culpeper Regional HospitalStatus: Active
Contact: Ali Mahjoub
Fairfax
Inova Schar Cancer InstituteStatus: Active
Contact: Shawna C. Willey
Phone: 571-472-1600
Richmond
VCU Massey Comprehensive Cancer CenterStatus: Active
Contact: Kandace P. McGuire
Phone: 804-828-9325
PRIMARY OBJECTIVES:
I. To determine whether treatment with pre- endocrine therapy (ET) compared to standard of care results in a decrease in treatment with breast conservation surgery (BCS) alone.
II. To determine whether treatment with pre- ET compared to standard of care results in a decrease in treatment with BCS + radiation therapy (RT) + adjuvant endocrine therapy (AET).
SECONDARY OBJECTIVES:
I. To determine whether treatment with pre-ET lessens Decision Conflict and Regret.
II. To assess whether patients’ final treatment correlates with their beliefs about breast cancer.
III. To assess whether treatment with pre-ET leads to improved Health Related Quality of Life compared to those treated with standard of care.
IV. To assess whether early side effects of ET correlate with patient treatment group within study arms.
V. To obtain data on recurrence and survival.
EXPLORATORY OBJECTIVES:
I. To assess long-term adherence to AET.
II. To assess whether patients’ final treatment correlates with their beliefs about breast cancer.
III. To assess whether short-term, patient-derived organoids can be established from larger pieces of surgical tissue of trial participants who have received AET.
IV. To evaluate whether larger pieces of surgical tissue can be cryopreserved for short-term organoid derivation after thawing and dissociation.
V. To evaluate whether patient-derived organoids exhibit short-term responses to endocrine therapy and radiotherapy that are patient-specific.
VI. To explore artificial intelligence algorithms as a means for calculating a prognostic score within breast tumors.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive ET for 90 days then undergo lumpectomy on day 91 with or without post-operative radiation and AET.
ARM II: Patients undergo lumpectomy with or without post-operative radiation and AET.
After completion of study intervention, patients are followed up at 90 days, 6, 12, 18 and 24 months.
Lead OrganizationUniversity of Virginia Cancer Center
Principal InvestigatorTrish Millard
