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A Pilot Study Utilizing Proteomic and Genomic Profiling for Patients With Metastatic Breast Cancer (SO2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01919749
First Posted: August 9, 2013
Last Update Posted: November 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Side-Out Foundation
Information provided by (Responsible Party):
Translational Drug Development
  Purpose
This study will use proteomic and genomic profiling to analyze tumor tissue to see if treatment selected by this analysis will benefit patients.

Condition Intervention
Metastatic Breast Cancer Other: treated recommended

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Translational Drug Development:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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.


Enrollment: 25
Study Start Date: August 2013
Study Completion Date: October 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
treatment
recommended treatment
Other: treated recommended
Treatment will be recommended after reviewing the profiling analysis
Other Name: treatment will be recommended after reviewing the profiling analysis

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01919749


Locations
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259-5499
United States, Virginia
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
Translational Drug Development
The Side-Out Foundation
Investigators
Principal Investigator: Stephen Anthony, DO Evergreen Hematology & Oncology
  More Information

Responsible Party: Translational Drug Development
ClinicalTrials.gov Identifier: NCT01919749     History of Changes
Other Study ID Numbers: SO-BCA-002
First Submitted: July 29, 2013
First Posted: August 9, 2013
Last Update Posted: November 18, 2016
Last Verified: November 2016

Keywords provided by Translational Drug Development:
breast cancer metastatic
molecular profiling
sequencing
profiling
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases