Genomic and Proteomic Profiling Targets Influenced Treatment in Metastatic Breast Cancer

Sponsor

Avera McKennan Hospital & University Health Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02470819

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Breast Cancer Breast Tumor Advanced Gynecologic Cancer	Genetic: Genetic profiling	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Two Arm Pilot Study Utilizing Molecular Profiling to Find Potential Targets and Influence Treatments for Patients With Metastatic Breast Cancer or Advanced Gynecological Malignancies

Study Start Date :

Mar 1, 2014

Actual Primary Completion Date :

Oct 30, 2018

Actual Study Completion Date :

Oct 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Targeted Therapy Those who will receive targeted therapy based on their genetic profiling	Genetic: Genetic profiling genetic profiling

Arm

Intervention/Treatment

Experimental: Targeted Therapy

Those who will receive targeted therapy based on their genetic profiling

Genetic: Genetic profiling

genetic profiling

Outcome Measures

Primary Outcome Measures

Progression-free survival [4 months]
Progression-free survival will be defined as the interval between the first dose of therapy and the occurrence of disease progression (fatal or non-fatal). Disease status will be assessed every 7 +/- 1 week until progression or time of treatment discontinuation, whichever is later. If progression is not observed at the end of therapy, patients will be assessed every 3 months until progression or further anti-cancer therapy.

Secondary Outcome Measures

Tumor assessment [4 months]
Radiographic response will be evaluated according to RECIST 1.1 criteria in all patients with measurable disease. All sites of disease must be evaluated using the baseline assessment methods. Confirmatory assessment of complete response or partial response must be performed no less than 4 weeks after the initial documentation of response.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Avera Cancer Institute	Sioux Falls	South Dakota	United States	57105

Sponsors and Collaborators

Avera McKennan Hospital & University Health Center

Investigators

Principal Investigator: Brian Leyland-Jones, MD, Avera McKennan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Avera McKennan Hospital & University Health Center

ClinicalTrials.gov Identifier:

NCT02470819

Other Study ID Numbers:

AMEM-2014-DOD001

First Posted:

Jun 12, 2015

Last Update Posted:

Nov 7, 2018

Last Verified:

Nov 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Nov 7, 2018