Metastatic Breast CancerSO2NCT01919749
A Pilot Study Utilizing Proteomic and Genomic Profiling for Patients With Metastatic Breast Cancer
A study testing treated recommended in people with Metastatic Breast Cancer, run by Translational Drug Development at 2 sites in United States.
Trial summary
This study will use proteomic and genomic profiling to analyze tumor tissue to see if treatment selected by this analysis will benefit patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- treated recommended
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2013to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Mayo Clinic
Scottsdale, Arizona, 85259-5499
About this study
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
This study will use proteomic and genomic profiling to analyze tumor tissue to see if treatment selected by this analysis will benefit patients.
Read the 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.
- Conditions
- Metastatic Breast Cancer
- Being tested
- treated recommended
- Keywords
- breast cancer metastatic, molecular profiling, sequencing, profiling, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treated recommendedOther
Also called treatment will be recommended after reviewing the profiling analysis
Treatment will be recommended after reviewing the profiling analysis
| Study group | Role | What they receive |
|---|---|---|
| treatment | Other | recommended treatment Receives: Other: treated recommended |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 24 months
Secondary outcomes (1)
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.
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Translational Drug Development
- Sponsor type
- University, hospital or other
- Collaborators
- Side-Out Foundation
- Responsible party
- Sponsor
- Investigators
- Stephen Anthony, DO, Principal investigator, Evergreen Hematology & Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919749
- Sponsor's protocol ID
- SO-BCA-002
- Acronym
- SO2
- Status last verified
- Nov 2022
- First submitted
- 29 Jul 2013
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01919749
- Acronym / sponsor ID
- SO2 / SO-BCA-002
- Conditions
- Metastatic Breast Cancer
- Keywords
- breast cancer metastatic, molecular profiling, sequencing, profiling, breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Translational Drug DevelopmentUniversity, hospital or other
- Collaborators
- Side-Out Foundation
- Study start
- Aug 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 9 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will use proteomic and genomic profiling to analyze tumor tissue to see if treatment selected by this analysis will benefit patients.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Other | Other: treated recommendedrecommended treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| treated recommendedAlso: treatment will be recommended after reviewing the profiling analysisTreatment will be recommended after reviewing the profiling analysis | Other | treatment |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Anthony, DO principal investigator
Evergreen Hematology & Oncology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing treated recommended in people with Metastatic Breast Cancer, run by Translational Drug Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.