I-CURE-1: A Phase II, Single Arm Study of Pembroluzimab Combined With Carboplatin in Patients With Circulating Tumor Cells (CTCs) Positive Her-2 Negative Metastatic Breast Cancer (MBC)
The purpose of the study is to evaluate the impact on progression-free survival (PFS) with the combination carboplatin - pembrolizumab in patients with CTC (circulating tumor cells) positive, HER2 negative metastatic breast cancer previously treated with anthracyclines and taxanes. Previous studies have indicated that recurrent breast cancers are more resistant to chemotherapy and maybe associated with a weak immune system. This study is investigating the use of an immune therapy drug, pembrolizumab, that has the ability to restore the capacity of controlling and killing cancer cells of an important component of your immune system called T-cells. Pembrolizumab has been found effective in other types of cancer and has already been approved by FDA for those indications, but the efficacy in breast cancer is still unknown. In this study, pembrolizumab will be combined with chemotherapy to increase the cancer cell killing. There is no control or placebo treatment in this study.
• Patients must be:
‣ Hormone receptor (HR) negative and HER-2 negative (triple negative breast cancer \[TNBC\]) metastatic breast cancer and have not received prior chemotherapy for metastatic disease
⁃ Demonstrated HER-2 negative MBC (0 or 1+ by immunohistochemistry \[IHC\] or non-amplified by fluorescence in situ hybridization \[FISH\]) according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAPA) guidelines
• Patients must be CTC positive (defined as CTCs \>= 5)
• Have measurable disease based on RECIST 1.1
• Be willing to provide archival tissue (if available) for correlative studies
‣ Note: The archived tumor tissue specimens may be from metastatic tumor specimen (first choice); in alternative, we can consider tissue from prior surgery or from prior diagnostic biopsy (second choice); unavailability of archived tissue will not render subject ineligible for study
• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance status
• Demonstrate adequate organ function, all screening labs should be performed within 14 days prior to registration
• Absolute neutrophil count (ANC) \>= 1,500 /mcL
• Platelet \>= 100,000 / mcL
• Hemoglobin \>= 9 g/dL or \>= 5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment)
• Serum creatinine =\< 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate \[GFR\] can also be used in place of creatinine or creatinine clearance \[CrCl\]) \>= 60 mL/min for subject with creatinine levels \> 1.5 X institutional ULN
• Serum total bilirubin =\< 1.5 X ULN OR direct bilirubin =\< ULN for subjects with total bilirubin levels \> 1.5 ULN
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 X ULN OR =\< 5 X ULN for subjects with liver metastases
• Albumin \>= 2.5 mg/dL
• International normalized ratio (INR) or prothrombin time (PT) =\< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants
• Activated partial thromboplastin time (aPTT) =\< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
• Female subject of childbearing potential (FOCBP) should have a negative urine or serum pregnancy within 7 days prior to registration; and must be repeated within 3 days (72 hours) prior to first dose of study drug; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
‣ (Note: A FOCBP is any woman \[regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice\] who meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy
∙ Has had menses at any time in the preceding 12 consecutive months \[and therefore has not been naturally postmenopausal for \> 12 months\])
• Female subjects of childbearing potential must be willing to use an adequate method of contraception as outlined in the appendices; contraception must be used for the course of the study through 120 days after the last dose of study medication
‣ Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
• Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
‣ Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
• Be willing and able to provide written informed consent/assent for the trial