Breast Cancer Clinical Trials

• Provision of signed and dated informed consent form

• Stated willingness to comply with all study procedures and availability for the duration of the study

• Age ≥ 18 years at the time of signing informed consent

• Expected survival ≥ 3 months in the judgment of the investigator

• ECOG PS 0-1

• Adequate Organ Function per the following criteria (within 10 days of study registration):

‣ Absolute lymphocyte count ≥ 400/mm3

⁃ Absolute neutrophil count ≥ 1000/mm3

⁃ Platelets ≥ 75,000/mm3

⁃ Hemoglobin ≥ 9g/dL

⁃ Serum creatinine \< 2.0 mg/dL OR measured or calculated creatinine clearance ≥ 50 ml/mm

⁃ Total bilirubin ≤ mg/dL

⁃ Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) \< 5.0 times normal

• Agreement to adhere to Lifestyle Considerations throughout study duration

• A diagnosis of either of the following:

• a. Prostate Cancer: i. Histological and/or cytological confirmation of prostate adenocarcinoma. ii. Participants must have progressive mCRPC at screening iii. Serum testosterone levels \<50 ng/dL during screening. iv. Must have progressed on at least one prior ARPI (abiraterone acetate, enzalutamide, apalutamide, or darolutamide).

• v. Participants must have ≥1 metastatic lesion that is present on baseline CT, MRI, or bone scan obtained ≤28 days prior to registration.

• b. Breast Cancer i. Histological and/or cytological confirmation of invasive breast cancer. ii. Participants must have previously treated metastatic breast cancer at screening. Metastatic breast cancer must be evaluable by RECIST 1.1 criteria.

∙ iii. Must have progressed on at least two prior endocrine or targeted therapies or at least two lines of cytotoxic chemotherapy. If HER2 positive, then must have progressed on or been intolerant of at least one HER2 targeted therapy.

∙ iv. Participants must have ≥1 metastatic lesion that is present on baseline CT, MRI, or bone scan obtained ≤28 days prior to registration.