Safety and Efficacy Study of Vintafolide and Vintafolide Plus Paclitaxel Compared to Paclitaxel Alone in Participants With Triple Negative Breast Cancer (TNBC) (MK-8109-004)

Breast Neoplasms Clinical Trial

Official title: A Phase IIa Open Label, Randomized Clinical Trial to Study the Safety and Efficacy of Vintafolide and the Combination of Vintafolide and Paclitaxel Compared to Paclitaxel in Subjects With Advanced Triple Negative Breast Cancer Using Etarfolatide (EC20) Subject Selection

Status Withdrawn

Clinical Trial Summary

The purpose of this study is to assess the efficacy and safety of vintafolide alone compared to vintafolide plus paclitaxel and paclitaxel alone in participants with with 100% positive folate receptor (FR) triple negative breast cancer (TNBC).

The primary hypothesis of this study is the vintafolide alone and/or vintafolide + paclitaxel will improve progression free survival (PFS) in participants with FR (100%) TNBC compared to paclitaxel alone.

Clinical Trial Description

During the screening stage, participants will be required to have a diagnostic computed tomography (CT) scan with etarfolatide (EC20) to identify target lesions and determine eligibility for treatment. After successful screening, during the treatment stage, participants will receive study drug (vintafolide, vintafolide + paclitaxel, or paclitaxel) for approximately four 28-day cycles. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Neoplasms

• NCT number: NCT01953536
• Study type: Interventional
• Source: Endocyte
• Status: Withdrawn
• Phase: Phase 2
• Start date: April 2014
• Completion date: November 2016