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Phase II Study Of Single-dose Cyclophosphamide +Pembrolizumab In Patients With Metastatic Triple Negative Breast Cancer
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).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Start Date
October 18, 2016
Primary Completion Date
May 1, 2022
Completion Date
May 1, 2023
Last Updated
May 22, 2023
40
ACTUAL participants
Pembrolizumab
DRUG
Cyclophosphamide
DRUG
Lead Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
NCT06649331
NCT06134375
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07029399