Metastatic Breast CancerNCT02470819
Genomic and Proteomic Profiling Targets Influenced Treatment in Metastatic Breast Cancer
A study testing Genetic profiling in people with Metastatic Breast Cancer and Breast Tumor, run by Avera McKennan Hospital & University Health Center at 1 site in United States.
Trial summary
The primary objective is to examine the impact on progression-free survival of targeted therapy for breast cancer suggested by proteomic and genomic profiling. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, Breast Tumor, Advanced Gynecologic Cancer
- What is being tested?
- Genetic profiling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to 30 Oct 2018
- 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
- Life expectancy of >3 months
- Diagnosis of metastatic breast cancer or an advanced gynecological malignancy with measurable disease
- Age greater than or equal to 18 years
- ECOG performance status of 0-1
- Able to undergo two biopsies to obtain tissue with first biopsy required and second biopsy optional
- Have failed or unable to tolerate previous treatment regimen
- Adequate organ and bone marrow function as defined by ANC ≥ 1.5 x 109/L; Hgb 9 g/dL; platelets greater than 100 x 109/L; creatinine ≤ 1.5 mg/dL; bilirubin ≤ 2.5 x ULN; AST and ALT ≤ 2.5 x ULN (or ≤ 5 x ULN if due to underlying liver metastases); INR ≤ 1.5 x ULN (except in the case of anticoagulation therapy)
Who cannot join
- Metastatic lesions that are not accessible to biopsy
- Symptomatic CNS metastasis
- Previous history of another malignancy within 5 years of study entry
- Uncontrolled concurrent illness
- Known HIV, HBB, and/or HCV infection
- Pregnant or breast feeding or childbearing potential and not using adequate birth control
Trial locations and contacts
1 site in 1 country.
United States1 site
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
About this study
Official title: A Two Arm Pilot Study Utilizing Molecular Profiling to Find Potential Targets and Influence Treatments for Patients With Metastatic Breast Cancer or Advanced Gynecological Malignancies
The primary objective is to examine the impact on progression-free survival of targeted therapy for breast cancer suggested by proteomic and genomic profiling.
Read the detailed description
To explore the impact of targeted therapy for breast cancer suggested by proteomic and genomic profiling using RPMA, targeted resequencing, IHC analysis, WGS, RNA-seq, and Exome sequencing on progression-free survival. When a molecular target cannot be identified, the patient will be treated with a therapy selected on an empirical basis by the investigator/treating physician at the individual site and will be followed for survival status. Only available, FDA-approved agents will be used.
- Being tested
- Genetic 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.
Genetic profilingGenetic
genetic profiling
| Study group | Role | What they receive |
|---|---|---|
| Targeted Therapy | Experimental | Those who will receive targeted therapy based on their genetic profiling Receives: Genetic: Genetic profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression-free survival will be defined as the interval between the first dose of therapy and the occurrence of disease progression (fatal or non-fatal). Disease status will be assessed every 7 +/- 1 week until progression or time of treatment discontinuation, whichever is later. If progression is not observed at the end of therapy, patients will be assessed every 3 months until progression or further anti-cancer therapy.
Measured: 4 months
Secondary outcomes (1)
Tumor assessment
Radiographic response will be evaluated according to RECIST 1.1 criteria in all patients with measurable disease. All sites of disease must be evaluated using the baseline assessment methods. Confirmatory assessment of complete response or partial response must be performed no less than 4 weeks after the initial documentation of response.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startMar 2014
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
Why it stopped: Investigator elected to end the study
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avera McKennan Hospital & University Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Leyland-Jones, MD, Principal investigator, Avera McKennan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470819
- Sponsor's protocol ID
- AMEM-2014-DOD001
- Status last verified
- Nov 2018
- First submitted
- 9 Jun 2015
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two Arm Pilot Study Utilizing Molecular Profiling to Find Potential Targets and Influence Treatments for Patients With Metastatic Breast Cancer or Advanced Gynecological Malignancies
- ClinicalTrials.gov ID
- NCT02470819
- Acronym / sponsor ID
- AMEM-2014-DOD001
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator elected to end the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Avera McKennan Hospital & University Health CenterUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 12 Jun 2015 (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.
The primary objective is to examine the impact on progression-free survival of targeted therapy for breast cancer suggested by proteomic and genomic profiling.
Detailed description
To explore the impact of targeted therapy for breast cancer suggested by proteomic and genomic profiling using RPMA, targeted resequencing, IHC analysis, WGS, RNA-seq, and Exome sequencing on progression-free survival. When a molecular target cannot be identified, the patient will be treated with a therapy selected on an empirical basis by the investigator/treating physician at the individual site and will be followed for survival status. Only available, FDA-approved agents will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Targeted Therapy | Experimental | Genetic: Genetic profilingThose who will receive targeted therapy based on their genetic profiling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Life expectancy of >3 months
- Diagnosis of metastatic breast cancer or an advanced gynecological malignancy with measurable disease
- Age greater than or equal to 18 years
- ECOG performance status of 0-1
- Able to undergo two biopsies to obtain tissue with first biopsy required and second biopsy optional
Key exclusion criteria (6 listed)
- Metastatic lesions that are not accessible to biopsy
- Symptomatic CNS metastasis
- Previous history of another malignancy within 5 years of study entry
- Uncontrolled concurrent illness
- Known HIV, HBB, and/or HCV infection
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 |
|---|---|---|
| Genetic profilinggenetic profiling | Genetic | Targeted Therapy |
Primary outcome
Progression-free survival
Time frame: 4 months
Progression-free survival will be defined as the interval between the first dose of therapy and the occurrence of disease progression (fatal or non-fatal). Disease status will be assessed every 7 +/- 1 week until progression or time of treatment discontinuation, whichever is later. If progression is not observed at the end of therapy, patients will be assessed every 3 months until progression or further anti-cancer therapy.
1 secondary outcome
Tumor assessment
Time frame: 4 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- 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.
Brian Leyland-Jones, MD principal investigator
Avera McKennan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genetic profiling in people with Metastatic Breast Cancer and Breast Tumor, run by Avera McKennan Hospital & University Health Center 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 7 inclusion and 6 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: withdrawn, as of the sponsor's last update on 7 Nov 2018. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 (time frame: 4 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 7 Nov 2018.