Study Of Single-dose Cyclophosphamide +Pembrolizumab In Patients With Metastatic Triple Negative Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02768701|
Recruitment Status : Active, not recruiting
First Posted : May 11, 2016
Last Update Posted : July 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Triple Negative Breast Cancer||Drug: Pembrolizumab Drug: Cyclophosphamide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study Of Single-dose Cyclophosphamide +Pembrolizumab In Patients With Metastatic Triple Negative Breast Cancer|
|Actual Study Start Date :||October 18, 2016|
|Estimated Primary Completion Date :||March 15, 2023|
|Estimated Study Completion Date :||March 15, 2023|
Experimental: Experimental: Single Arm
Subjects will receive a single dose (300 mg/m2) of cyclophosphamide given the day before cycle 1 of pembrolizumab (200 mg), which will be administered every 3 weeks.
Subjects will be treated every 3 weeks with 200 mg of pembrolizumab via a 30 minute infusion.
Other Name: Keytruda
A single 300 mg/m2 dose of cyclophosphamide IV over 30-60 minutes will be administered on Day 1 of this study.
- The Progression Free Survival (PFS) [ Time Frame: Day 1 of treatment until disease progression or death from any cause, assessed up to 2 years ]Estimate of progression-free survival (PFS) in patients with metastatic TNBC receiving single immune-priming dose of cyclophosphamide + pembrolizumab. PFS is defined as time from day 1 of treatment until disease progression or death from any cause.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02768701
|United States, District of Columbia|
|George Washington University-Medical Faculty Associates|
|Washington, District of Columbia, United States, 20037|
|United States, North Carolina|
|Lineberger Comprehensive Cancer Center|
|Chapel Hill, North Carolina, United States, 27599|
|Cone Health Cancer Center|
|Greensboro, North Carolina, United States, 27403|
|Rex Cancer Center|
|Raleigh, North Carolina, United States, 27607|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Elizabeth C Dees, MD||UNC Lineberger Comprehensive Cancer Center|