A Pilot Study Utilizing Proteomic and Genomic Profiling for Patients With Metastatic Breast Cancer (SO2)
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ClinicalTrials.gov Identifier: NCT01919749 |
Recruitment Status :
Completed
First Posted : August 9, 2013
Last Update Posted : November 18, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Breast Cancer | Other: treated recommended | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 25 participants |
Allocation: | N/A |
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 |
Study Start Date : | August 2013 |
Actual Primary Completion Date : | August 2016 |
Actual Study Completion Date : | October 2016 |

Arm | Intervention/treatment |
---|---|
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 |
- 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 ]
- 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 ]
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
United States, Arizona | |
Mayo Clinic | |
Scottsdale, Arizona, United States, 85259-5499 | |
United States, Virginia | |
Virginia Cancer Specialists | |
Fairfax, Virginia, United States, 22031 |
Principal Investigator: | Stephen Anthony, DO | Evergreen Hematology & Oncology |
Responsible Party: | Translational Drug Development |
ClinicalTrials.gov Identifier: | NCT01919749 |
Other Study ID Numbers: |
SO-BCA-002 |
First Posted: | August 9, 2013 Key Record Dates |
Last Update Posted: | November 18, 2016 |
Last Verified: | November 2016 |
breast cancer metastatic molecular profiling sequencing profiling breast cancer |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |