This study is designed to assess the safety and clinical activity of tamoxifen and the COX inhibitor, aspirin, given in combination with standard AC-T chemotherapy (doxorubicin, cyclophosphamide, and paclitaxel) for the treatment of high-risk estrogen receptor (ER)+, human epidermal growth factor receptor 2 (HER2)- breast cancer. If successful, the study could improve long-term outcomes for a subpopulation of women with aggressive stage I-III ER+/HER2- breast cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
325 mg aspirin daily during AC-T chemotherapy
Tamoxifen (either 20 mg daily or 10 mg twice a day) during AC-T chemotherapy
Doxorubicin (60 mg/m2) Given by IV with cyclophosphamide
University of Virginia
Charlottesville, Virginia, United States
Pathologic complete response (pCR) rate
Rate of participants that no longer have any tumor identified at the time of surgery after chemotherapy
Time frame: At the time of surgery, following completion of AC-T chemotherapy, usually about 7.5 months
Adverse events (AEs)
Frequency of adverse events occurring during and shortly after the study intervention
Time frame: From time of informed consent through 30 days after completion of study intervention (for AEs) or 90 days after completion of study intervention (for Serious AEs)
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Cyclophosphamide (600 mg/m2) Given by IV with doxorubicin
Paclitaxel 80 mg/m2 or 175 mg/m2 based on provider preference. Given by IV after completion of doxorubicin/cyclophosphamide therapy