NCT01074814

Pilot Study Using Molecular Profiling to Find Potential Targets & Select Treatments for Pts With Met br ca

A Pilot Study Utilizing Molecular Profiling by IHC, FISH, DNA Microarray, and Reverse Phase Protein Microarray (RPMA) of Patients' Tumors to Find Potential Targets and Select Treatments for Patients With Metastatic Breast Cancer.

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Translational Drug Development · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the response rate, that is the % of patients with non-progression of their metastatic breast cancer after 4 months on treatment that was selected by molecular testing and proteomics.

Detailed description

To determine the percent of patients with refractory breast cancer where molecular profiling and RPMA-based protein pathway activation analysis of their tumor, can change the clinical course of their disease (i.e. produce a Growth Modulation Index (GMI) ≥1.3). The GMI is calculated as the ratio of Progression-free survival (PFS) under molecular profiling and RPMA analysis selected treatment to the time to progression (TTP) for the most recent regimen the patient has progressed on.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Approved therapy will be assigned based on molecular profile and RPMA results	treatment will be assigned based on IHC\< FISH, DNA microarray and RPMA results

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2010-02-24
• Last updated: 2023-09-28
• Results posted: 2023-09-28

Locations

3 sites across 1 country: United States