Oxaloacetate for the Improvement of Cognitive Complaints in Stage 0-IIIA Breast Cancer Survivors

Inclusion Criteria:

• Women with a diagnosis of early stage breast cancer (stage 0, I, II, IIIa) who areat least 12 months after surgery, chemotherapy, radiation, but may be on endocrinetherapy or HER-2 targeted therapy, and not more than 5 years after their breastcancer diagnosis

• No evidence of active/recurrent breast cancer or other serious chronic illness

• Has significant cognitive complaints, defined as a score of < 12 on thePatient-Reported Outcomes Measurement Information System (PROMIS) Adult version (v) 2.0 - Cognitive Function 4a

• Is geographically accessible, and able to participate in a study of 8-10 weeksduration

• Ability to complete evaluation surveys in English

• The effects of oxaloacetate on the developing human fetus at the recommendedtherapeutic dose are unknown. For this reason, women of childbearing potential mustagree to use adequate contraception (barrier method of birth control; intrauterinedevice [IUD]; abstinence) prior to study entry and for the duration of studyparticipation. Women of any age who have had their ovaries and/or uterus removedwill not be at risk for pregnancy and will not require contraception. Should a womanbecome pregnant or suspect she is pregnant while participating in this study, sheshould inform her study physician immediately. Menopausal status will be establishedas follows: Women who are 55 years or older and who are not menstruating will beconsidered postmenopausal and not at risk for pregnancy. Women who are less than 55years old who are menstruating will be considered premenopausal and will requirecontraception. Women who are less than 55 years with an intact uterus and ovarieswho are not menstruating and have not had a menstrual period within the past 2 yearswill have an follicle-stimulating hormone (FSH) and estradiol measured. If thevalues are in postmenopausal range the woman will be considered postmenopausal andshe will not be considered at risk for pregnancy

• Ability to understand and the willingness to sign a written informed consentdocument

Exclusion Criteria:

• Has another serious or chronic medical or psychiatric condition that contributes tosubstantial physical or emotional disability that would detract from participatingin the planned study

• Taking chronic medications that would interfere with cognitive functioning such asmedications for sleep, anxiety, narcotics for pain, use of illicit drugs or cannabis

• Participants may not be receiving any other investigational agents

• History of allergic reactions attributed to compounds of similar chemical orbiologic composition to oxaloacetate

• Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliancewith study requirements

• Pregnant or breast-feeding women are excluded from this study because the safety ofoxaloacetate in this setting is unknown. A pregnancy test will be performed on allwomen with an intact uterus and ovaries who are not determined to be postmenopausal