S-equol in Women With Triple Negative Breast Cancer
This will be a single arm, non-randomized phase II clinical trial of women with newly diagnosed triple negative breast cancer. After having a core needle biopsy of the breast confirming triple negative breast cancer, eligible women enrolled on the study will be treated with S-equol at a dose of 50 mg PO twice daily for 10-21 days. Appropriate patients will be offered the study at their first clinic visits with medical oncology. Patients will be issued the drug and will start taking the
drug the day they sign consent. During this treatment period, patients will continue with routine pre-operative planning and evaluations. This study will not delay patients proceeding to surgical intervention. Patients will continue on S-equol until the day of their surgery, which is anticipated to be about 14 days. Since the time from diagnosis to surgery varies slightly between patients, we will aim for 14 days of treatment, but will include women who receive treatment for at least 10 days and up to 21 days in our analysis. This ensures that we do not delay proceeding with standard of care treatment for early stage breast cancer which is surgical resection and ensures that we do not stop S-equol days prior to surgical resection. Patients will be evaluated the day of surgery (between day 10-21) for toxicity check and drug return. If patients are not expected to have surgery, such as those with inoperable, metastatic disease or needing neoadjuvant
chemotherapy with the aim of breast conservation, a repeat core needle biopsy will be conducted in the medical oncology clinic on day 14. Patients will then be re-evaluated in the medical oncology clinic on day 42 as part of a routine post-surgical or treatment follow up appointment with repeat physical exam, toxicity check and routine laboratory testing to evaluate for any toxicity to S-equol. We do not anticipate any additional or extra visits to the clinic in order to
participate in this study.