Clinical Trial: A Phase 2 Study of Eribulin Followed by AC as Preoperative Therapy for HER2-negative Inflammatory Breast Cancer

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 2 Study of Eribulin Followed by Doxorubicin and Cyclophosphamide as Preoperative Therapy for HER2-negative Inflammatory Breast Cancer

Brief Summary: This research study is studying a drug called eribulin combined with standard treatment as a possible preoperative treatment for HER2 negative inflammatory breast cancer.

Detailed Summary:

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied..

Eribulin works by interfering with cancer cell division, growth, and spread.

The goal of this research study is to evaluate inflammatory breast cancer's response to treatment with eribulin followed by AC chemotherapy when given as a preoperative chemotherapy treatment for participants with HER2 negative inflammatory breast cancer.


Sponsor: Dana-Farber Cancer Institute

Current Primary Outcome: Pathologic Complete Response [ Time Frame: 112 Days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Disease Free Survival [ Time Frame: 2 years ]
  • Time to Treatment Failure [ Time Frame: 2 years ]
  • Overall Survival [ Time Frame: 2 Years ]
  • Pathologic disease response at mastectomy will be reported as "residual disease burden (RCB)". [ Time Frame: 2 Years ]
  • RT-qPCR assessment of gene expression of 10-EMT-related genes and 15-genes involved in modulating vessel phenotype or EC-PVC interactions will be compared following treatment with eribulin. [ Time Frame: 2 Years ]
    The paired expression levels of each gene at the two time points will be summarized graphically and descriptively. Wilcoxon signed rank test will be used to determine if there are any significant changes in the expression level of each gene and the clinical outcome of pCR, DFS, OS, RCB.
  • To correlate changes in imaging (Ktrans ve, vp, and initial area under the curve (iAUC)) with genomic changes determined on core biopsies of the breast sampled at the same time points. [ Time Frame: 2 Years ]


Original Secondary Outcome: Same as current

Information By: Dana-Farber Cancer Institute

Dates:
Date Received: December 2, 2015
Date Started: December 2015
Date Completion: February 2023
Last Updated: November 18, 2016
Last Verified: November 2016