Metastatic Breast CancerEarly Phase 1Side-OutNCT01074814
Pilot Study Using Molecular Profiling to Find Potential Targets & Select Treatments for Pts With Met br ca
A Early Phase 1 study testing Approved therapy will be assigned based on molecular profile and RPMA results in people with Metastatic Breast Cancer, run by Translational Drug Development at 3 sites in United States.
Trial summary
The purpose of this study is to determine the response rate, that is the % of patients with non-progression of their metastatic breast cancer after 4 months on treatment that was selected by molecular testing and proteomics. 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?
- Approved therapy will be assigned based on molecular profile and RPMA results
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2010to Jul 2012
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Have a life expectancy of greater than 3 months
- metastatic breast cancer, with measurable or evaluable non-measurable disease
- Have progressed on at least 3 prior chemotherapeutic or biological regimens
- Be defined as refractory to the last line of therapy according to the following criteria: Documented disease progression under the last treatment or within two months of the last treatment dosing AND Have received ≥ 30 days of the last treatment AND Have discontinued for progression by RECIST 1.1 criteria
- ≥18 years of age
- ECOG 0-1
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- willing to undergo a biopsy or surgical procedure to obtain tissue
- Must have been off their prior regimen for ≥ 3 weeks or 5 x half life of drug
- Have adequate organ and bone marrow function as defined below:
- Female patients of child-bearing 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 unless they are post-menopausal for at least one year or are surgically sterile
- Male patients must use a form of barrier contraception approved by the Investigator during the study and for at least one month after treatment discontinuation.
Who cannot join
- Tumor biopsy intended for use in the current study which was performed more than 2 months prior
- Frozen material is not available/obtained
- Metastatic lesion is not accessible to biopsy
- Patients with > 6 months treatment under the last line of therapy
- Patients with symptomatic CNS metastasis. Patients with a history of CNS metastases who have been treated 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
- 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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- 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
- Known HIV, HBV, HCV infection
- Pregnant or breast-feeding patients or any patient with childbearing potential not using adequate contraception.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Fairfax North Virginia Hematology Oncology
Fairfax, Virginia, 22031
Tgen Clinical Research Services
Scottsdale, Arizona, 85258
Evergreen Hematology and Oncology
Spokane, Washington, 99218
About this study
Official title: A Pilot Study Utilizing Molecular Profiling by IHC, FISH, DNA Microarray, and Reverse Phase Protein Microarray (RPMA) of Patients' Tumors to Find Potential Targets and Select Treatments for Patients With Metastatic Breast Cancer.
The purpose of this study is to determine the response rate, that is the % of patients with non-progression of their metastatic breast cancer after 4 months on treatment that was selected by molecular testing and proteomics.
Read the detailed description
To determine the percent of patients with refractory breast cancer where molecular profiling and RPMA-based protein pathway activation analysis of their tumor, can change the clinical course of their disease (i.e. produce a Growth Modulation Index (GMI) ≥1.3). The GMI is calculated as the ratio of Progression-free survival (PFS) under molecular profiling and RPMA analysis selected treatment to the time to progression (TTP) for the most recent regimen the patient has progressed on.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Approved therapy will be assigned based on molecular profile and RPMA results
- Keywords
- Metastatic Breast Cancer, Molecular profiling
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Approved therapy will be assigned based on molecular profile and RPMA resultsDrug
Also called Approved therapy will be administered based on molecular profile and RPMA results
treatment will be assigned based on IHC< FISH, DNA microarray and RPMA results
| Study group | Role | What they receive |
|---|---|---|
| Metastatic Breast Cancer Patients | Other | Blood drawn for molecular profiling Receives: Drug: Approved therapy will be assigned based on molecular profile and RPMA results |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth Modulation Index (GMI) Greater Than or Equal to 1.3
The primary objective was to determine the % of patients with refractory breast cancer where MMP-informed selection of approved cancer therapies could change the clinical course of their disease to produce a Growth Modulation Index (GMI) greater than 1.3. The GMI was calculated as the PFS with MMP-selected therapy/time to progression (TTP) on last prior therapy. A GMI of 1.3 was selected because 30% or greater improvement in PFS with MMP-selected therapy compared to previous TTP would be considered clinically meaningful.
Measured: 6-20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Translational Drug Development
- Sponsor type
- University, hospital or other
- Collaborators
- Side-Out Foundation
- Responsible party
- Sponsor
- Investigators
- Gayle Jameson, RNMSNACNP-BC, Principal investigator, Scottsdale Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01074814
- Sponsor's protocol ID
- SO-BCA-001
- Acronym
- Side-Out
- Status last verified
- Nov 2022
- First submitted
- 22 Feb 2010
- Last updated
- 28 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Jameson GS, Petricoin EF, Sachdev J, Liotta LA, Loesch DM, Anthony SP, Chadha MK, Wulfkuhle JD, Gallagher RI, Reeder KA, Pierobon M, Fulk MR, Cantafio NA, Dunetz B, Mikrut WD, Von Hoff DD, Robert NJ. A pilot study utilizing multi-omic molecular profiling to find potential targets and select individualized treatments for patients with previously treated metastatic breast cancer. Breast Cancer Res Treat. 2014 Oct;147(3):579-88. doi: 10.1007/s10549-014-3117-1. Epub 2014 Sep 11.
PubMed 25209003
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Utilizing Molecular Profiling by IHC, FISH, DNA Microarray, and Reverse Phase Protein Microarray (RPMA) of Patients' Tumors to Find Potential Targets and Select Treatments for Patients With Metastatic Breast Cancer.
- ClinicalTrials.gov ID
- NCT01074814
- Acronym / sponsor ID
- Side-Out / SO-BCA-001
- Conditions
- Metastatic Breast Cancer
- Keywords
- Metastatic Breast Cancer, Molecular profiling
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Translational Drug DevelopmentUniversity, hospital or other
- Collaborators
- Side-Out Foundation
- Study start
- Mar 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 24 Feb 2010 (estimated)
- Results
- Posted 28 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the response rate, that is the % of patients with non-progression of their metastatic breast cancer after 4 months on treatment that was selected by molecular testing and proteomics.
Detailed description
To determine the percent of patients with refractory breast cancer where molecular profiling and RPMA-based protein pathway activation analysis of their tumor, can change the clinical course of their disease (i.e. produce a Growth Modulation Index (GMI) ≥1.3). The GMI is calculated as the ratio of Progression-free survival (PFS) under molecular profiling and RPMA analysis selected treatment to the time to progression (TTP) for the most recent regimen the patient has progressed on.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic Breast Cancer Patients | Other | Drug: Approved therapy will be assigned based on molecular profile and RPMA resultsBlood drawn for molecular profiling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Have a life expectancy of greater than 3 months
- metastatic breast cancer, with measurable or evaluable non-measurable disease
- Have progressed on at least 3 prior chemotherapeutic or biological regimens
- Be defined as refractory to the last line of therapy according to the following criteria: Documented disease progression under the last treatment or within two months of the last treatment dosing AND Have received ≥ 30 days of the last treatment AND Have discontinued for progression by RECIST 1.1 criteria
- ≥18 years of age
Key exclusion criteria (9 listed)
- Tumor biopsy intended for use in the current study which was performed more than 2 months prior
- Frozen material is not available/obtained
- Metastatic lesion is not accessible to biopsy
- Patients with > 6 months treatment under the last line of therapy
- Patients with symptomatic CNS metastasis. Patients with a history of CNS metastases who have been treated 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 |
|---|---|---|
| Approved therapy will be assigned based on molecular profile and RPMA resultsAlso: Approved therapy will be administered based on molecular profile and RPMA resultstreatment will be assigned based on IHC< FISH, DNA microarray and RPMA results | Drug | Metastatic Breast Cancer Patients |
Primary outcome
Growth Modulation Index (GMI) Greater Than or Equal to 1.3
Time frame: 6-20 weeks
The primary objective was to determine the % of patients with refractory breast cancer where MMP-informed selection of approved cancer therapies could change the clinical course of their disease to produce a Growth Modulation Index (GMI) greater than 1.3. The GMI was calculated as the PFS with MMP-selected therapy/time to progression (TTP) on last prior therapy. A GMI of 1.3 was selected because 30% or greater improvement in PFS with MMP-selected therapy compared to previous TTP would be considered clinically meaningful.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25209003Jameson GS, Petricoin EF, Sachdev J, Liotta LA, Loesch DM, Anthony SP, Chadha MK, Wulfkuhle JD, Gallagher RI, Reeder KA, Pierobon M, Fulk MR, Cantafio NA, Dunetz B, Mikrut WD, Von Hoff DD, Robert NJ. A pilot study utilizing multi-omic molecular profiling to find potential targets and select individualized treatments for patients with previously treated metastatic breast cancer. Breast Cancer Res Treat. 2014 Oct;147(3):579-88. doi: 10.1007/s10549-014-3117-1. Epub 2014 Sep 11.
- Individual participant dataSharing planned: No
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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.
Gayle Jameson, RNMSNACNP-BC principal investigator
Scottsdale Healthcare
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Approved therapy will be assigned based on molecular profile and RPMA results in people with Metastatic Breast Cancer, run by Translational Drug Development at 3 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 11 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 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Growth Modulation Index (GMI) Greater Than or Equal to 1.3 (time frame: 6-20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01074814, which also lists 1 linked publication.
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 Sep 2023.