Clinical Trial: Pilot Study of Paclitaxel Plus Pembrolizumab in Metastatic HER2-Negative Breast Cancer

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: LCI-BRE-H2N-PEPP-001: A Pilot Study of Paclitaxel Plus Pembrolizumab in Patients With Metastatic HER2-Negative Breast Cancer (The PePPy Trial)

Brief 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.

Detailed Summary: 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.
Sponsor: Antoinette Tan

Current Primary Outcome: Grade 3 or 4 treatment-related adverse event [ Time Frame: 18 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Objective response rate [ Time Frame: 2 years ]
  • Progression-free survival [ Time Frame: 2 years ]
  • Overall survival [ Time Frame: 2 years ]
  • Disease control rate [ Time Frame: 2 years ]
  • Duration of response [ Time Frame: 2 years ]


Original Secondary Outcome: Same as current

Information By: Carolinas Healthcare System

Dates:
Date Received: January 10, 2017
Date Started: February 2017
Date Completion: February 2020
Last Updated: January 10, 2017
Last Verified: January 2017