OncoMatch/Clinical Trials/NCT03213041
Pembrolizumab and Carboplatin in Treating Patients With Circulating Tumor Cells Positive Metastatic Breast Cancer
Is NCT03213041 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab and Carboplatin for estrogen receptor negative.
Treatment: Carboplatin · Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Triple-Negative Breast Cancer
Biomarker criteria
Required: HER2 (ERBB2) negative (0 or 1+ by IHC or non-amplified by FISH)
HER-2 negative (0 or 1+ by immunohistochemistry [IHC] or non-amplified by fluorescence in situ hybridization [FISH])
Required: ESR1 negative
Hormone receptor (HR) negative
Required: PR (PGR) negative
Hormone receptor (HR) negative
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Exception: no prior chemotherapy for metastatic disease
have not received prior chemotherapy for metastatic disease
Cannot have received: anti-PD-1 therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
Cannot have received: anti-PD-L1 therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
Cannot have received: anti-PD-L2 therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
Cannot have received: monoclonal antibody
Exception: within 4 weeks prior to study day 1 or not recovered from AEs
Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or who has not recovered (i.e., <= grade 1 or baseline) from adverse events (AEs) due to agents administered more than 28 days earlier
Cannot have received: chemotherapy
Exception: within 14 days prior to registration or not recovered from AEs
Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 14 days prior to registration or who has not recovered (i.e., <= grade 1 or at baseline) from AEs due to a previously administered agent
Cannot have received: targeted small molecule therapy
Exception: within 14 days prior to registration or not recovered from AEs
Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 14 days prior to registration or who has not recovered (i.e., <= grade 1 or at baseline) from AEs due to a previously administered agent
Cannot have received: radiation therapy
Exception: within 14 days prior to registration or not recovered from AEs
Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 14 days prior to registration or who has not recovered (i.e., <= grade 1 or at baseline) from AEs due to a previously administered agent
Lab requirements
Blood counts
ANC >= 1,500 /mcL; Platelet >= 100,000 / mcL; Hemoglobin >= 9 g/dL or >= 5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment)
Kidney function
Serum creatinine <= 1.5 X ULN OR measured or calculated creatinine clearance >= 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN
Liver function
Serum total bilirubin <= 1.5 X ULN OR direct bilirubin <= ULN for subjects with total bilirubin levels > 1.5 ULN; AST and ALT <= 2.5 X ULN OR <= 5 X ULN for subjects with liver metastases; Albumin >= 2.5 mg/dL
Demonstrate adequate organ function, all screening labs should be performed within 14 days prior to registration
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Northwestern University · Chicago, Illinois
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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