Clinical Trials Logo

Clinical Trial Summary

The primary objective of this study is to assess the safety and feasibility of the following two regimens: Cohort A) phased regimen of pembrolizumab in which paclitaxel is followed by paclitaxel plus pembrolizumab and Cohort B) concurrent regimen of paclitaxel plus pembrolizumab. The primary safety objective is to evaluate the overall grade 3 or 4 treatment-related adverse event rate for each cohort and compare them to relevant historical controls.


Clinical Trial Description

This is an open-label randomized pilot research study to determine if the study drug, pembrolizumab, is safe to use in combination with a chemotherapy drug called paclitaxel. This study will have the following two regimens: Cohort A) phased regimen of pembrolizumab in which paclitaxel is followed by paclitaxel plus pembrolizumab and Cohort B) concurrent regimen of paclitaxel plus pembrolizumab. A total of 40 evaluable subjects will be enrolled over an enrollment period of 18-24 months. The study is planned to enroll approximately 20 evaluable subjects in each treatment cohort. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03018080
Study type Interventional
Source Wake Forest University Health Sciences
Contact
Status Completed
Phase Phase 2
Start date June 12, 2017
Completion date August 5, 2022

See also
  Status Clinical Trial Phase
Active, not recruiting NCT02480933 - Silent Breast Cancer A Study of the Disease Prevalence Held by Imaging Guided Biopsies in Autopsy Specimens N/A
Terminated NCT01705340 - Akt Inhibitor MK2206, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With Locally Advanced or Metastatic HER2-Positive Breast , Gastric, or Gastroesophageal Cancer That Cannot Be Removed By Surgery Phase 1
Terminated NCT01222377 - Endoscopic Breast Surgery in Treating Patients With Breast Cancer N/A
Completed NCT00244881 - A Phase II Study of AZD2171 in Breast Cancer Stage IV (10006202) Phase 2
Completed NCT00425672 - ONTAK® in Treating Patients With Advanced Breast Cancer That Did Not Respond to Previous Treatment Phase 1/Phase 2
Completed NCT00096434 - Sorafenib in Treating Patients With Metastatic Breast Cancer Phase 2
Terminated NCT01217411 - RO4929097 and Whole-Brain Radiation Therapy or Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Breast Cancer Phase 1
Completed NCT01037790 - Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer Phase 2
Active, not recruiting NCT00791037 - Vaccine Therapy in Treating Patients With Stage IV Breast Cancer Phase 1/Phase 2
Completed NCT00559507 - Saracatinib in Treating Patients With Metastatic or Locally Advanced Breast Cancer That Cannot Be Removed By Surgery Phase 2
Completed NCT00119262 - Bevacizumab and Combination Chemotherapy in Patients With Lymph Node Positive Breast Cancer Phase 2
Terminated NCT00095888 - 3-AP and Gemcitabine in Treating Patients With Refractory Metastatic Breast Cancer Phase 2
Completed NCT00098605 - Lapatinib in Treating Brain Metastases in Patients With Stage IV Breast Cancer and Brain Metastases Phase 2
Completed NCT00068588 - GTI-2040 and Capecitabine in Treating Patients With Metastatic Breast Cancer Phase 2
Terminated NCT00071942 - Vaccine Therapy in Treating Patients With Metastatic Breast Cancer Phase 1
Recruiting NCT05501704 - ETHAN - ET for Male BC Phase 2
Completed NCT02046421 - Carboplatin, Gemcitabine Hydrochloride, and Mifepristone in Treating Patients With Advanced Breast Cancer or Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer Phase 1
Completed NCT01869764 - Omega-3 Fatty Acid in Treating Patients With Stage I-III Breast Cancer Phase 2
Completed NCT01720602 - Vorinostat in Treating Patients With Stage IV Breast Cancer Receiving Hormone Therapy N/A
Terminated NCT01931709 - FDG PET and DCE-MRI in Predicting Response to Treatment in Patients With Breast Cancer N/A