The purpose of this study is to evaluate pembrolizumab therapy in patients with triple-negative breast cancer (TNBC) who have received at least one prior line of therapy.
This phase II, single-arm, multicenter study will evaluate efficacy and toxicity of administration of pembrolizumab following cyclophosphamide therapy, in advanced stage triple-negative breast cancer. Duration of Therapy Treatment may continue until one of the following occurs: * Disease progression * Inter-current illness that prevents further administration of treatment * Unacceptable adverse event(s) * Pregnancy * Patient decides to withdraw from study treatment, * General or specific changes in the patient's condition render the patient unacceptable for further treatment in the judgment of the investigator * Completed 24 months of uninterrupted treatment with pembrolizumab or 35 administrations of study medication, whichever is later Duration of Follow Up * Subjects will be followed for up to 3 years after removal from study treatment or until death, whichever occurs first. * Patients removed from study for unacceptable adverse events (AEs) will be followed until resolution or stabilization of the event(s).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Subjects will be treated every 3 weeks with 200 mg of pembrolizumab via a 30 minute infusion.
A single 300 mg/m2 dose of cyclophosphamide IV over 30-60 minutes will be administered on Day 1 of this study.
George Washington University-Medical Faculty Associates
Washington D.C., District of Columbia, United States
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Cone Health Cancer Center
Greensboro, North Carolina, United States
Rex Cancer Center
Raleigh, North Carolina, United States
The Progression Free Survival (PFS)
PFS is defined as the time from day1 of the study treatment until disease progression or death. Disease progression is defined as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST)1.1 based on computerized tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET) images or assessment of the physician. RECIST v.1.1: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: Up to 5 years
Quantification of the Change in Regulatory T Cells (Tregs) During the Study Treatment.
Regulatory T cells (Tregs) are counted before the treatment start and during the treatment. Methods: Blood Sample collection.
Time frame: Up to 2 years
Overall Response Rate (ORR)
ORR is defined as the percentage of patients with \[compete response (CR) + partial response (PR)\] per RECIST1.1 based on computerized tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET) images. RECIST v.1.1: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions;
Time frame: Up to 2 years
Duration of Response (DOR)
DOR is defined as the time from documentation of tumor response by RECIST1.1 \[(CR) + (PR)\] to disease progression by RECIST 1.1. It will be measured from when the time measurement criteria are first met for complete response or partial response (whichever status is recorded first) until the first date of progressive disease or death. Patients who neither progress nor die will be censored on the date of their last tumor assessment.
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University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Time frame: Up to 3 years
Disease Control Rate (DCR)
DCR is defined as the percentage of participants, who achieve \[compete response (CR) + partial response (PR) and stable disease (SD) per RECIST1.1. If best response is SD, then it must last more than 6 months to be included in calculation of DCR, to be considered to have received clinical benefit from the treatment regimen. RECIST v.1.1: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: Up to 2 years
Overall Survival (OS)
OS is defined as the time from D1 of study treatment to death from any cause.
Time frame: Up to 3 years
Treatment Associated Toxicity
Treatment Associated Toxicity is defined as the number of participants with Grade 3-4 adverse events associated with study treatment. Adverse Events were classified and graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v.4 based on changes in laboratory parameters, vital signs, and other safety assessments per standard of care.
Time frame: Up to 3 years