Genomic and Proteomic Profiling Targets Influenced Treatment in Metastatic Breast Cancer

NCT ID: NCT02470819

Last Updated: 2018-11-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2018-10-30

Brief Summary

The primary objective is to examine the impact on progression-free survival of targeted therapy for breast cancer suggested by proteomic and genomic profiling.

Detailed Description

To explore the impact of targeted therapy for breast cancer suggested by proteomic and genomic profiling using RPMA, targeted resequencing, IHC analysis, WGS, RNA-seq, and Exome sequencing on progression-free survival. When a molecular target cannot be identified, the patient will be treated with a therapy selected on an empirical basis by the investigator/treating physician at the individual site and will be followed for survival status. Only available, FDA-approved agents will be used.

Conditions

Metastatic Breast Cancer; Breast Tumor; Advanced Gynecologic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Targeted Therapy

Those who will receive targeted therapy based on their genetic profiling

Group Type: EXPERIMENTAL

Genetic profiling

Intervention Type: GENETIC

genetic profiling

Interventions

Genetic profiling

genetic profiling

Intervention Type: GENETIC

Eligibility Criteria

Inclusion Criteria

• Life expectancy of >3 months
• Diagnosis of metastatic breast cancer or an advanced gynecological malignancy with measurable disease
• Age greater than or equal to 18 years
• ECOG performance status of 0-1
• Able to undergo two biopsies to obtain tissue with first biopsy required and second biopsy optional
• Have failed or unable to tolerate previous treatment regimen
• Adequate organ and bone marrow function as defined by ANC ≥ 1.5 x 109/L; Hgb 9 g/dL; platelets greater than 100 x 109/L; creatinine ≤ 1.5 mg/dL; bilirubin ≤ 2.5 x ULN; AST and ALT ≤ 2.5 x ULN (or ≤ 5 x ULN if due to underlying liver metastases); INR ≤ 1.5 x ULN (except in the case of anticoagulation therapy)

Exclusion Criteria

• Metastatic lesions that are not accessible to biopsy
• Symptomatic CNS metastasis
• Previous history of another malignancy within 5 years of study entry
• Uncontrolled concurrent illness
• Known HIV, HBB, and/or HCV infection
• Pregnant or breast feeding or childbearing potential and not using adequate birth control

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Avera McKennan Hospital & University Health Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Leyland-Jones, MD

Role: PRINCIPAL_INVESTIGATOR

Avera McKennan

Locations

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Countries

United States

Other Identifiers

AMEM-2014-DOD001

Identifier Type: -

Identifier Source: org_study_id