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Aspirin, Tamoxifen, and Combination Chemotherapy for the Treatment of ER Positive, HER2 Negative Stage I-III Breast Cancer

Trial Status: Active

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.

Inclusion Criteria

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Newly diagnosed with ER+/HER2- stage I-III breast cancer according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines and the 8th edition of the American Joint Committee on Cancer (AJCC); ER positive is defined as >= 1% positive nuclear staining
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Life expectancy >= 6 months
  • Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for at least 3 months following the last dose of tamoxifen
  • If genomic profiling has been performed (OncotypeDx, Mammaprint or other), then the score must be in a medium- or high-risk range
  • Absolute neutrophil count (ANC) >= 1000/mm^3
  • Platelets >= 100,000/mm^3
  • Hemoglobin >= 9 g/dL
  • Serum creatinine or glomerular filtration rate (GFR) =< 1.5 x upper limit of normal (ULN)
  • Bilirubin =< 1.5 x ULN (except in patients with Gilbert’s disease, where bilirubin to 4 x ULN or direct bilirubin =< ULN is allowed)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN
  • Alkaline phosphatase =< 2.5 x ULN
  • Ability to take oral medication

Exclusion Criteria

  • Receipt of any systemic treatment for the current diagnosis of breast cancer (breast biopsy, excisional biopsy, or other local therapy is acceptable as long as residual disease is present and is appropriate for systemic chemotherapy and additional curative intent resection)
  • Current use of anticoagulant (e.g. warfarin [Coumadin], heparin, direct oral anticoagulants [DOAC]) within 72 hours of registration
  • Pregnancy or lactation
  • Currently in prison
  • Requirement for supplemental oxygen therapy
  • Current active cancer other than breast cancer
  • History of severe bleeding that, in the treating investigator’s opinion, would put the patient at increased risk with daily 325 mg aspirin use
  • Known allergic reactions to aspirin, tamoxifen, doxorubicin, cyclophosphamide, or paclitaxel
  • Participants classified according to the New York Heart Association classification as having class II - IV heart disease
  • History of thrombosis or cerebrovascular accident


University of Virginia Cancer Center
Status: ACTIVE
Contact: Patrick Michael Dillon
Phone: 434-924-8073


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.


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.


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.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
University of Virginia Cancer Center

Principal Investigator
Patrick Michael Dillon

  • Primary ID 21822
  • Secondary IDs NCI-2020-04003, Breast 51
  • ID NCT04038489