Tamoxifen and Pegylated Liposomal Doxorubicin for the Treatment of Patients With Metastatic or Inoperable, Locally Advanced Triple Negative Breast Cancer

Inclusion Criteria

• •Patients with pathologically confirmed metastatic triple negative breast cancer (ER ≤ 10%) that have been previously treated with at least 2 lines of therapy in the metastatic setting
• •Patients must have a confirmed eligible TP53 genomic alteration, as determined by the Roswell Park Oncomine™ Precision Assay (OPA) or similar CLIA-approved assay, using either an archival metastatic tumor sample or, if unavailable, a fresh biopsy. Uncertainty about the eligibility of the TP53 genomic alteration for this study can be resolved by discussion with the study PI
• •The tumor must be HER-2 negative by immunochemistry (IHC) 0-1+ or IHC 2 + and fluorescence in situ hybridization (FISH) negative
• •Patients must be ≥ 18 years of age
• •Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• •Absolute neutrophil count (ANC) ≥ 1500/ μL
• •Hemoglobulin (hb) ≥ 9 g/dL
• •Platelet count ≥ 100,000/ μL
• •Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
• •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2 x ULN
• •Creatinine clearance \> 60 mL/min (Cockroft-Gault Equation)
• •Left ventricular ejection fraction (LVEF) assessment must be performed within 30 days prior to enrollment. (LVEF assessment performed by 2-D echocardiogram is preferred; however, multigated acquisition scan \[MUGA\] scan may be substituted based on institutional preferences). The LVEF must be ≥ 50% regardless of the cardiac imaging facility's lower limit of normal
• •Patients must be able to swallow oral medications
• •Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
• •Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure