- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01919749
A Pilot Study Utilizing Proteomic and Genomic Profiling for Patients With Metastatic Breast Cancer (SO2)
March 24, 2023 updated by: Translational Drug Development
A Pilot Study Utilizing Proteomic and Genomic Profiling by Reverse Phase Protein Microarray (RPMA), IHC Analysis, RNA Seq, and Exome Sequencing of Patients' Tumors to Find Potential Targets and Select Treatments for Patients With Metastatic Breast Cancer
This study will use proteomic and genomic profiling to analyze tumor tissue to see if treatment selected by this analysis will benefit patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To examine the impact of targeted therapy for breast cancer based upon proteomic and genomic profiling using RPMA, IHC analysis, RNA-Seq, and Exome sequencing on PFS and GMI.
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85259-5499
- Mayo Clinic
-
-
Virginia
-
Fairfax, Virginia, United States, 22031
- Virginia Cancer Specialists
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Understand and provide written informed consent and HIPAA Authorization prior to initiation of any study-specific procedures
- Have a life expectancy > 3 months
- Have a diagnosis of metastatic breast cancer with measurable disease (RECIST 1.1)
- Have progressed on ≥ 1 prior chemotherapeutic and/or hormonal regimen for advanced disease.
- Have documentation of progression (by RECIST 1.1) on the treatment regimen immediately prior to entering this study
- Be ≥ 18 years of age
- Have a ECOG score of 0-1
- Be a good medical candidate for and willing to undergo a biopsy or surgical procedures to obtain tissue, which may or may not be part of the patient's routine care for their malignancy. The requirements for the amount of tissue required for analysis are detailed in Section 6.2.2.
- Have been off their prior regimen for ≥ 3 weeks or 5 x half-life of drug, whichever is shorter and have recovered from the side effects (≤ grade 1) of that regimen
- Have adequate organ and bone marrow function
- Female patients of childbearing potential must have a negative pregnancy test and agree to use at least one form of contraception during the study and for at least one month after treatment discontinuation. For the purposes of this study, child-bearing potential is defined as: all female patients that were not in post-menopause for at least one year or are surgically sterile
- Male patients must use a form of barrier contraception approved by the investigator / treating physician during the study and for at least one month after treatment discontinuation.
Exclusion Criteria:
- Have a tumor biopsy intended for use in the current study that was performed more than 2 months prior to analysis
- Have metastatic lesion that is not accessible to biopsy
- Had > 6 months treatment under the last line of therapy
- Have interventional cancer therapy conducted after the biopsy was collected prior to analysis
- Have symptomatic CNS metastasis. Patients with a history of CNS metastases who have been treated with whole brain irradiation must be stable without symptoms for 4 weeks after completion of treatment, with image documentation required, and must be either off steroids or on a stable dose of steroids for ≥ 2 weeks prior to enrollment
- Have any previous history of another malignancy (other than cured basal cell carcinoma of the skin or cured in-situ carcinoma of the cervix) within 5 years of study entry
- Have uncontrolled concurrent illness including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmias, psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent
- Have known HIV, HBV, HCV infection
- Are pregnant or breast-feeding patients or any patient with childbearing potential not using adequate contraception.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: treatment
recommended treatment
|
Treatment will be recommended after reviewing the profiling analysis
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine the impact of targeted therapy for breast cancer based upon proteomic and genomic profiling using RPMA, IHC analysis, RNA-Seq, and Exome sequencing on PFS and GMI.
Time Frame: 24 months
|
Determine the impact of targeted therapy for breast cancer based upon proteomic and genomic profiling using RPMA, IHC analysis, RNA-Seq, and Exome sequencing on PFS and GMI.
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Record the frequency with which proteomic, IHC, and genomic profiling analysis of a patient's tumor by RPMA, IHC analysis, RNA-Seq, and Exome sequencing yields a target against which there is an FDA-approved agent or therapeutic regimen.
Time Frame: 24 months
|
Record the frequency with which proteomic, IHC, and genomic profiling analysis of a patient's tumor by RPMA, IHC analysis, RNA-Seq, and Exome sequencing yields a target against which there is an FDA-approved agent or therapeutic regimen.
|
24 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perform RPMA based batch analysis of all samples at the conclusion of this study, to measure 100-150 protein signaling targets. Protein activation will be correlated with clinical response.
Time Frame: 24 months
|
The data from this exploratory analysis will help generate the hypothesis for a future prospective study.
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Stephen Anthony, DO, Evergreen Hematology & Oncology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
October 1, 2016
Study Registration Dates
First Submitted
July 29, 2013
First Submitted That Met QC Criteria
August 7, 2013
First Posted (Estimate)
August 9, 2013
Study Record Updates
Last Update Posted (Actual)
March 28, 2023
Last Update Submitted That Met QC Criteria
March 24, 2023
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SO-BCA-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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