This phase II trial investigates the side effects of aspirin, tamoxifen, and standard of care combination chemotherapy, and assesses how well they work before surgery for the treatment of patients with estrogen receptor (ER) positive, HER2 negative stage I-III breast cancer. Aspirin is a drug that reduces pain, fever, inflammation, and blood clotting. Estrogen can cause the growth of breast cancer cells. Tamoxifen may help fight breast cancer by blocking the use of estrogen by the tumor cells. Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving aspirin, tamoxifen, and combination chemotherapy may help to remove some, if not all, tumor cells prior to undergoing surgery.
Additional locations may be listed on ClinicalTrials.gov for NCT04038489.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To assess the clinical activity of the combination of COX inhibition and chemoendocrine therapy.
II. To assess the safety of the combination of COX inhibition and chemoendocrine therapy.
EXPLORATORY OBJECTIVES:
I. To describe the effect of COX inhibition plus chemoendocrine therapy on immunologic profiles in the tumor microenvironment.
II. To describe the effect of COX inhibition plus chemoendocrine therapy on immunologic profiles in the periphery
III. To examine potential biomarker profiles in the breath.
OUTLINE:
Patients receive aspirin orally (PO) once daily (QD) and tamoxifen PO QD or twice daily (BID) starting at the beginning of chemotherapy through 1 week prior to surgery. Patients also receive standard of care doxorubicin hydrochloride intravenously (IV), cyclophosphamide IV, and either high-dose or low-dose paclitaxel IV. Treatment with doxorubicin hydrochloride and cyclophosphamide repeats every 2 or 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Treatment with low-dose paclitaxel repeats weekly for 12 cycles, and treatment with high-dose paclitaxel repeats every 2-3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Approximately 4-6 weeks after chemotherapy, patients undergo standard of care surgery.
Patients are followed up at 2-4 weeks after completion of standard of care surgery.
Lead OrganizationUniversity of Virginia Cancer Center
Principal InvestigatorPatrick Michael Dillon
