A Phase II Study of Anti-PD-1 (MK-3475) Therapy in Patients With Metastatic Inflammatory Breast Cancer (IBC) or Non-IBC Triple Negative Breast Cancer (TNBC) Who Have Achieved Clinical Response or Stable Disease to Prior Chemotherapy
This phase II trial studies how well pembrolizumab works in treating patients with stage IV
inflammatory breast cancer or triple-negative breast cancer that has spread to other places
in the body (metastatic) or has come back (recurrent), and who have achieved clinical
response or stable disease to prior chemotherapy. Immunotherapy with monoclonal antibodies,
such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere
with the ability of tumor cells to grow and spread.
I. To assess the efficacy of pembrolizumab (MK-3475) as a single agent in patients with
metastatic inflammatory breast cancer (IBC) and non-IBC triple-negative breast cancer (TNBC).
I. To investigate the association between biomarkers in the peripheral blood and tumor
tissue, such as PD-L1 expression, with safety and efficacy for IBC or non-IBC TNBC patients
treated with MK-3475.
II. To determine the disease control rate of metastatic IBC or non-IBC TNBC patients who have
achieved clinical response or stable disease to the systemic therapy.
III. To investigate the association between biomarkers and efficacy by ribonucleic acid
(RNA)-sequencing of exosomes in blood and tumor for IBC or non-IBC TNBC patients.
Patients receive pembrolizumab intravenously (IV) over approximately 30 minutes on day 1.
Courses repeat every 21 days for up to 24 months in the absence of disease progression or
After completion of study treatment, patients are followed up at approximately 1 and 3
Edema, Erythema, Estrogen Receptor Negative, HER2/Neu Negative, Peau d'Orange, Progesterone Receptor Negative, Recurrent Inflammatory Breast Carcinoma, Stage IV Inflammatory Breast Carcinoma, Triple-Negative Breast Carcinoma
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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