Actively Recruiting
Pembrolizumab and Carboplatin in Treating Patients With Circulating Tumor Cells Positive Metastatic Breast Cancer
Led by Northwestern University · Updated on 2021-05-03
100
Participants Needed
1
Research Sites
302 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pembrolizumab and Carboplatin in Treating Patients With Circulating Tumor Cells Positive Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have metastatic breast cancer that is hormone receptor negative and HER2 negative (triple negative breast cancer) and have not received prior chemotherapy for metastatic disease
- Confirmed HER2 negative metastatic breast cancer by standard testing guidelines
- Have circulating tumor cells (CTCs) count of 5 or more
- Have measurable disease based on RECIST 1.1 criteria
- Willing to provide archived tumor tissue if available
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function as evidenced by screening lab tests within 14 days prior to registration
- Absolute neutrophil count (ANC) of 1,500 or higher per mcL
- Platelet count of 100,000 or higher per mcL
- Hemoglobin level of 9 g/dL or higher without recent transfusion or erythropoietin dependency
- Serum creatinine less than or equal to 1.5 times the upper limit of normal or creatinine clearance of 60 mL/min or higher
- Serum total bilirubin less than or equal to 1.5 times upper limit of normal or direct bilirubin less than or equal to normal
- AST and ALT levels less than or equal to 2.5 times upper limit of normal, or up to 5 times if liver metastases are present
- Albumin level of 2.5 mg/dL or higher
- INR or prothrombin time less than or equal to 1.5 times upper limit of normal unless on anticoagulants with therapeutic levels
- Activated partial thromboplastin time less than or equal to 1.5 times upper limit of normal unless on anticoagulants with therapeutic levels
- Female participants of childbearing potential must have a negative pregnancy test within 7 days prior to registration and again within 3 days before first dose
- Female participants of childbearing potential must agree to use effective contraception during the study and for 120 days after last dose
- Male participants must agree to use effective contraception during the study and for 120 days after last dose
- Able and willing to provide written informed consent
You will not qualify if you...
- HER2 positive breast cancer by standard testing guidelines
- Currently participating or have recently participated (within 28 days) in another investigational study
- Diagnosed with immunodeficiency or receiving immunosuppressive therapy within 7 days prior to registration
- History of active tuberculosis
- Allergic to pembrolizumab or its ingredients
- Received prior anti-cancer monoclonal antibody within 4 weeks or not recovered from related side effects
- Received chemotherapy, targeted therapy, or radiation therapy within 14 days or not recovered from related side effects (except for neuropathy grade 2 or less)
- Not recovered from recent major surgery
- Have another cancer that progressed or required treatment within last 5 years except certain skin cancers or treated cervical cancer
- Have active brain metastases or carcinomatous meningitis; stable treated brain metastases allowed
- Have active autoimmune disease requiring systemic treatment in past 2 years
- Have active or history of severe pneumonitis requiring steroids
- Have active infection requiring systemic treatment
- Have conditions or disorders that could interfere with study participation or results
- Have psychiatric or substance abuse disorders interfering with study cooperation
- Pregnant, breastfeeding, or planning to conceive or father children during and 120 days after study
- Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents
- Known HIV infection
- Active hepatitis B or C infection
- Received live vaccine within 30 days before study start (inactivated flu vaccines allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
S
Study Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here