Metastatic Breast CancerPhase 2NCT02008994
Phase II Study Using Genomic & Proteomic Profiling to Influence Treatments for Patients With Metastatic Breast Cancer
A Phase 2 study testing Genomic and Proteomic Profiling in people with Metastatic Breast Cancer, run by Sanford Health at 1 site in United States.
Trial summary
Genes are the basic "instruction book" for the cells that make up our bodies and are made out of DNA. Many research studies are done to find the best possible way to treat patients with cancer. 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?
- Genomic and Proteomic Profiling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jan 2014
- Phase
- Phase 2
- 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 of >3 months
- Have a diagnosis of metastatic breast cancer with measurable disease (RECIST 1.1)
- Have documentation of progression if applicable (by RECIST 1.1) on the treatment regimen immediately prior to entering this study.
- Be ≥ 18 years of age
- Have an ECOG score of 0-1
Show all 14Show fewer
- Be a good medical candidate for and willing to undergo two biopsies or surgical procedures to obtain tissue, which may or may not be part of the patient's routine care for their malignancy. The 1st biopsy is required and the 2nd biopsy is optional.
- Have documented lack of response or documented progression form last therapy.
- Have adequate organ and bone marrow function as defined below:
- Bone marrow: absolute neutrophil count (ANC) ≥ 1.5 x 109/L; hemoglobin 9 g/dL; platelets > 100 x 109/L
- Renal: creatinine clearance ≥ 60 mL/min (calculated according to Cockcroft and Gault) or creatinine ≤ 1.5 mg/dL
- Hepatic: bilirubin ≤ 2.5 x the upper limit of normal (ULN); aspartate transaminases (AST/SGOT); alanine transaminases (ALT/SGPT) ≤ 2.5 x ULN (or ≤ 5 x ULN if due to underlying liver metastases); INR ≤ 1.5 x ULN (except in the case of anti-coagulation therapy)
- 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 lesions that are not accessible to biopsy
- Have had 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Pilot Study Utilizing Genomic and Proteomic Profiling to Find Potential Targets and Influence Treatments for Patients With Metastatic Breast Cancer
Genes are the basic "instruction book" for the cells that make up our bodies and are made out of DNA. Many research studies are done to find the best possible way to treat patients with cancer. Recently there has been a great deal of interest in developing new anticancer agents that are more targeted to a patient's individual genetic information, as well as diseases caused by defects in a person's genes.
Identification of precisely which treatments to use against a specific patient's tumor is challenging. In this study, four cutting-edge technologies will be used to identify genomic (information we get from DNA and RNA) and proteomic (information we get from proteins) targets for the treatment of your tumor. These four tests will be used together to gather information about your tumor giving doctors and scientists a better understanding of the structure of your tumor and what the best treatment or combination of treatments may be for you. The therapy you receive to treat your tumor will be based on your medical history, previous treatments for your disease if applicable, current state of health, and the findings from these four tests. The therapy you ultimately receive will be selected by your doctor in consultation with a panel of experts in cancer and cancer genomics (the Treatment Selection Committee).
Read the detailed description
DNA contains genetic information that acts as a blueprint for how parts of your body are made and work, determining such things as eye and hair color. DNA is made up of long strands of repeating letters that form a code. The order in which these letters are written is very precise. In the same way that a spelling mistake in a word could change its meaning entirely (for example, mean and meat), a single change in the sequence of DNA can lead to a change in how the body works, which may lead to disease. Currently, researchers and doctors know some of the genetic changes that may result in disease, but they do not know all of the genetic changes that can cause disease.
Proteins are the basic building blocks of your body. The parts of your body such as your muscles, your skin, and your organs are made up mostly of proteins. DNA provides the plans, or instructions, for how each protein should be made. If there is a change in your DNA, there may be a change in how a protein is made. Sometimes these changes can lead to disease. To make a protein, the cells in your body take the DNA and make a copy called RNA. The cells read the RNA to make the protein. DNA can be thought of as the original master plan with RNA being photocopies of this plan. The number of copies of RNA can determine the amount of protein that can be made. If the body needs more protein, it can make more RNA but if it needs less protein, it can also shred the RNA so that it cannot be read. The amount of a particular RNA or protein can also be important in how the body works. Too much or too little of a particular protein can also lead to disease. Understanding the relationship between DNA, RNA and proteins can be important in knowing what causes disease and how to treat it.
Identification of precisely which treatments to use against a specific patient's tumor is challenging. In this study, four cutting-edge technologies will be used to identify genomic (information we get from DNA and RNA) and proteomic (information we get from proteins) targets for the treatment of your tumor. These four tests will be used together to gather information about your tumor giving doctors and scientists a better understanding of the structure of your tumor and what the best treatment or combination of treatments may be for you. The therapy you receive to treat your tumor will be based on your medical history, previous treatments for your disease if applicable, current state of health, and the findings from these four tests. The therapy you ultimately receive will be selected by your doctor in consultation with a panel of experts in cancer and cancer genomics (the Treatment Selection Committee).
The purpose of this study is to examine the impact of targeted therapy for breast cancer based upon proteomic and genomic profiling using four different methods of analysis.
- Reverse Phase Protein Microarray will be used to determine how often there are specific proteins that could make the tumor susceptible or resistant to treatment.
- Immunohistochemistry will look for specific markers of disease in DNA.
- RNA sequencing will be used to help doctors and scientists understand how genes are working.
- Low pass whole genome and exome sequencing will be used to help identify variants in DNA.
The goal of this study will be to enroll at least 25 women who will receive therapy influenced by the results derived from genomic and proteomic profiling. Up to 30 women will receive treatment suggested by an identified target and up to 10 women will receive treatment that the subject and her doctor choose. The actual treatment of disease will be based upon multiple factors, including current physical condition, prior therapies if applicable, standard labs and tests, and physician's preference. The results from the genomic and proteomic profiling will add to the available information that will be used to aid us in deciding upon the course of therapy.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Genomic and Proteomic Profiling
- Keywords
- metastatic breast cancer, breast cancer, genomics, personalized medicine, precision oncology, breast cancer treatment, metastatic breast cancer treatment, genetic testing and breast cancer treatment, breast cancer trial, metastatic breast cancer trial
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genomic and Proteomic ProfilingOther
Following review of targets by the Treatment Selection Committee, the treating physician will decide whether to continue with planned therapy or alter the course of treatment based on the genomic results.
| Study group | Role | What they receive |
|---|---|---|
| Genomic and Proteomic Profiling | Experimental | * Reverse Phase Protein Microarray will be used to determine how often there are specific proteins that could make your tumor susceptible or resistant to treatment.
* Immunohistochemistry will look for specific markers of disease in your DNA.
* RNA sequencing will be used to help doctors and scientists understand how your genes are working.
* Low pass whole genome and exome sequencing will be used to help identify variants in your DNA. Receives: Other: Genomic and Proteomic Profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival as a result of targeted therapy for breast cancer suggested by proteomic and genomic profiling using RPMA, targeted resequencing, IHC analysis, WGS, RNA-Seq, and Exome sequencing.
Measured: Disease status will be assessed every 7 ± 1 weeks until progression or time of treatment discontinuation, whichever is later.
Secondary outcomes (9)
The frequency in which proteomic, IHC, and genomic profiling analysis of a tumor by RPMA, targeted resequencing, IHC analysis, WGS, RNA-Seq, and Exome sequencing yields a target.
Measured: Results of profiling will be made available to investigators within 10 working days of receipt of tissue specimens.
The frequency of changes to initial treatment recommendations after re-biopsy and analysis after 7 ± 2 days of treatment.
Measured: After 7 ± 2 days of treatment.
Results of LCM vs non-LCM samples on determination of driving mutations, transcripts, and alternative pathway activation.
Measured: Within one year after enrollment.
The percent of time in which RPMA, targeted resequencing, IHC analysis, RNA-Seq, and Exome sequencing based treatment is different than that which would have been selected by the patient's physician.
Measured: Within one year of study closing to enrollment.
Structural changes and copy number variants meaning after identification using low pass whole genome sequencing (WGS).
Measured: At initial biopsy and day 7 biopsy (if performed).
Response rate (according to RECIST 1.1 response criteria) - the percent of patients with non-progression at 4 months, and - overall survival, in patients whose therapy is selected by proteomic and genomic analysis and IHC analysis.
Measured: At 4 months.
Number of patients, as a whole, where the optimal tissue biomarker subset is most predictive of a given therapy leading to an improved outcome.
Measured: Within one year of closing to enrollment.
Physician and patient expectations, attitudes, experiences, and psychological responses to the use of proteomic and genomic profiling in breast cancer.
A questionnaire will be provided to physicians and patients to measure their knowledge regarding genomics and the interaction with cancer care.
Measured: Within one year of closing to enrollment.
Patient symptoms identified by the Therapy-Related Symptom Checklist (TRSC) correlate with any associated SNPs identified through genomic analysis
Measured: Within one year of closing to enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startSep 2013
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: Resignation of Principal Investigator
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanford Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Pearce, PhD, Study director, Sanford Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008994
- Sponsor's protocol ID
- SH SSKT001
- Status last verified
- Mar 2015
- First submitted
- 30 Oct 2013
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Pilot Study Utilizing Genomic and Proteomic Profiling to Find Potential Targets and Influence Treatments for Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT02008994
- Acronym / sponsor ID
- SH SSKT001
- Conditions
- Metastatic Breast Cancer
- Keywords
- metastatic breast cancer, breast cancer, genomics, personalized medicine, precision oncology, breast cancer treatment, metastatic breast cancer treatment, genetic testing and breast cancer treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Resignation of Principal Investigator
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Sanford HealthUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 11 Dec 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.
Genes are the basic "instruction book" for the cells that make up our bodies and are made out of DNA. Many research studies are done to find the best possible way to treat patients with cancer. Recently there has been a great deal of interest in developing new anticancer agents that are more targeted to a patient's individual genetic information, as well as diseases caused by defects in a person's genes.
Identification of precisely which treatments to use against a specific patient's tumor is challenging. In this study, four cutting-edge technologies will be used to identify genomic (information we get from DNA and RNA) and proteomic (information we get from proteins) targets for the treatment of your tumor. These four tests will be used together to gather information about your tumor giving doctors and scientists a better understanding of the structure of your tumor and what the best treatment or combination of treatments may be for you. The therapy you receive to treat your tumor will be based on your medical history, previous treatments for your disease if applicable, current state of health, and the findings from these four tests. The therapy you ultimately receive will be selected by your doctor in consultation with a panel of experts in cancer and cancer genomics (the Treatment Selection Committee).
Detailed description
DNA contains genetic information that acts as a blueprint for how parts of your body are made and work, determining such things as eye and hair color. DNA is made up of long strands of repeating letters that form a code. The order in which these letters are written is very precise. In the same way that a spelling mistake in a word could change its meaning entirely (for example, mean and meat), a single change in the sequence of DNA can lead to a change in how the body works, which may lead to disease. Currently, researchers and doctors know some of the genetic changes that may result in disease, but they do not know all of the genetic changes that can cause disease.
Proteins are the basic building blocks of your body. The parts of your body such as your muscles, your skin, and your organs are made up mostly of proteins. DNA provides the plans, or instructions, for how each protein should be made. If there is a change in your DNA, there may be a change in how a protein is made. Sometimes these changes can lead to disease. To make a protein, the cells in your body take the DNA and make a copy called RNA. The cells read the RNA to make the protein. DNA can be thought of as the original master plan with RNA being photocopies of this plan. The number of copies of RNA can determine the amount of protein that can be made. If the body needs more protein, it can make more RNA but if it needs less protein, it can also shred the RNA so that it cannot be read. The amount of a particular RNA or protein can also be important in how the body works. Too much or too little of a particular protein can also lead to disease. Understanding the relationship between DNA, RNA and proteins can be important in knowing what causes disease and how to treat it.
Identification of precisely which treatments to use against a specific patient's tumor is challenging. In this study, four cutting-edge technologies will be used to identify genomic (information we get from DNA and RNA) and proteomic (information we get from proteins) targets for the treatment of your tumor. These four tests will be used together to gather information about your tumor giving doctors and scientists a better understanding of the structure of your tumor and what the best treatment or combination of treatments may be for you. The therapy you receive to treat your tumor will be based on your medical history, previous treatments for your disease if applicable, current state of health, and the findings from these four tests. The therapy you ultimately receive will be selected by your doctor in consultation with a panel of experts in cancer and cancer genomics (the Treatment Selection Committee).
The purpose of this study is to examine the impact of targeted therapy for breast cancer based upon proteomic and genomic profiling using four different methods of analysis.
- Reverse Phase Protein Microarray will be used to determine how often there are specific proteins that could make the tumor susceptible or resistant to treatment.
- Immunohistochemistry will look for specific markers of disease in DNA.
- RNA sequencing will be used to help doctors and scientists understand how genes are working.
- Low pass whole genome and exome sequencing will be used to help identify variants in DNA.
The goal of this study will be to enroll at least 25 women who will receive therapy influenced by the results derived from genomic and proteomic profiling. Up to 30 women will receive treatment suggested by an identified target and up to 10 women will receive treatment that the subject and her doctor choose. The actual treatment of disease will be based upon multiple factors, including current physical condition, prior therapies if applicable, standard labs and tests, and physician's preference. The results from the genomic and proteomic profiling will add to the available information that will be used to aid us in deciding upon the course of therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Genomic and Proteomic Profiling | Experimental | Other: Genomic and Proteomic Profiling* Reverse Phase Protein Microarray will be used to determine how often there are specific proteins that could make your tumor susceptible or resistant to treatment. * Immunohistochemistry will look for specific markers of disease in your DNA. * RNA sequencing will be used to help doctors and scientists understand how your genes are working. * Low pass whole genome and exome sequencing will be used to help identify variants in your DNA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Understand and provide written informed consent and HIPAA Authorization prior to initiation of any study-specific procedures
- Have a life expectancy of >3 months
- Have a diagnosis of metastatic breast cancer with measurable disease (RECIST 1.1)
- Have documentation of progression if applicable (by RECIST 1.1) on the treatment regimen immediately prior to entering this study.
- Be ≥ 18 years of age
Key exclusion criteria (8 listed)
- Have a tumor biopsy intended for use in the current study that was performed more than 2 months prior to analysis
- Have metastatic lesions that are not accessible to biopsy
- Have had 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
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 |
|---|---|---|
| Genomic and Proteomic ProfilingFollowing review of targets by the Treatment Selection Committee, the treating physician will decide whether to continue with planned therapy or alter the course of treatment based on the genomic results. | Other | Genomic and Proteomic Profiling |
Primary outcome
Progression free survival as a result of targeted therapy for breast cancer suggested by proteomic and genomic profiling using RPMA, targeted resequencing, IHC analysis, WGS, RNA-Seq, and Exome sequencing.
Time frame: Disease status will be assessed every 7 ± 1 weeks until progression or time of treatment discontinuation, whichever is later.
9 secondary outcomes
The frequency in which proteomic, IHC, and genomic profiling analysis of a tumor by RPMA, targeted resequencing, IHC analysis, WGS, RNA-Seq, and Exome sequencing yields a target.
Time frame: Results of profiling will be made available to investigators within 10 working days of receipt of tissue specimens.
The frequency of changes to initial treatment recommendations after re-biopsy and analysis after 7 ± 2 days of treatment.
Time frame: After 7 ± 2 days of treatment.
Results of LCM vs non-LCM samples on determination of driving mutations, transcripts, and alternative pathway activation.
Time frame: Within one year after enrollment.
The percent of time in which RPMA, targeted resequencing, IHC analysis, RNA-Seq, and Exome sequencing based treatment is different than that which would have been selected by the patient's physician.
Time frame: Within one year of study closing to enrollment.
Structural changes and copy number variants meaning after identification using low pass whole genome sequencing (WGS).
Time frame: At initial biopsy and day 7 biopsy (if performed).
Response rate (according to RECIST 1.1 response criteria) - the percent of patients with non-progression at 4 months, and - overall survival, in patients whose therapy is selected by proteomic and genomic analysis and IHC analysis.
Time frame: At 4 months.
Number of patients, as a whole, where the optimal tissue biomarker subset is most predictive of a given therapy leading to an improved outcome.
Time frame: Within one year of closing to enrollment.
Physician and patient expectations, attitudes, experiences, and psychological responses to the use of proteomic and genomic profiling in breast cancer.
Time frame: Within one year of closing to enrollment.
Patient symptoms identified by the Therapy-Related Symptom Checklist (TRSC) correlate with any associated SNPs identified through genomic analysis
Time frame: Within one year of closing to enrollment.
Results and safety
The study was stopped early (reason given: Resignation of Principal Investigator). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
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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.
David Pearce, PhD study director
Sanford Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Genomic and Proteomic Profiling in people with Metastatic Breast Cancer, run by Sanford Health at 1 site 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 14 inclusion and 8 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: stopped early, as of the sponsor's last update on 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Resignation of Principal Investigator). Results are not available in the source record.
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?
Progression free survival as a result of targeted therapy for breast cancer suggested by proteomic and genomic profiling using RPMA, targeted resequencing, IHC analysis, WGS, RNA-Seq, and Exome sequencing. (time frame: Disease status will be assessed every 7 ± 1 weeks until progression or time of treatment discontinuation, whichever is later.). 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 24 Mar 2015.