Breast CancerNCT01232881
Predicting Response and Toxicity in Patients Receiving Lonafarnib for Breast Cancer
An observational study of Breast Cancer, run by Hoosier Cancer Research Network at 1 site in United States.
Trial summary
This is a tumor and serum collection study for patients with advanced breast cancer receiving treatment with lonafarnib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tumor Sample and Serum Sample
- Type of treatment
- Surgery or procedure
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Nov 2010
- Phase
- Observational
- 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
Study population: The study population will be limited to patients with advanced breast cancer receiving treatment with lonafarnib.
Who may be able to join
- Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age > 18 years.
- Planned treatment with lonafarnib for metastatic breast cancer.
- Must consent to have a biopsy performed to obtain fresh tissue or be able to identify a formalin fixed paraffin embedded (FFPE) tissue block in which tumor samples can be obtained to complete the testing for this study.
Who cannot join
- Planned treatment with any other treatment regimen
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
Official title: Predicting Response and Toxicity in Patients Receiving Lonafarnib for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study
This is a tumor and serum collection study for patients with advanced breast cancer receiving treatment with lonafarnib.
Read the detailed description
OUTLINE: This is a multi-center study.
Sample Collection:
- Tumor sample
- Serum sample
Treatment Regimen:
- All registered patients must be planning treatment with lonafarnib
- Conditions
- Breast Cancer
- Being tested
- Tumor Sample, Serum Sample
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor SampleProcedure or surgery
Tumor sample submission can consist of a fresh frozen tissue sample or a formalin-fixed paraffin embedded tissue block.
Serum SampleProcedure or surgery
Serum is to be collected prior to the initiation of lonafarnib treatment and 28 days after the last dose of lonafarnib.
| Study group | Role | What they receive |
|---|---|---|
| Tumor and Serum Collection | Tumor sample submission can consist of a fresh frozen tissue sample or a formalin-fixed paraffin embedded tissue block.
Serum is to be collected prior to the initiation of lonafarnib treatment and 28 days after the last dose of lonafarnib. Receives: Procedure: Tumor Sample; Procedure: Serum Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
To correlate tumor gene expression (genomic profile) with response to lonafarnib in patients with advanced breast cancer
Measured: 24 months
Secondary outcomes (4)
To correlate serum and tumor proteomic profiles with response to lonafarnib
Measured: 24 months
To compare serum and tissue proteomic analyses
Measured: 24 months
To compare genomic and proteomic profiles
Measured: 24 months
To correlate toxicity and /or response with drug-specific pharmacogenomic parameters
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 posted2 Nov 2010 (estimated)
- Study startAug 2009
- Primary completionNov 2010
- Study completionNov 2010
Why it stopped: funding terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoosier Cancer Research Network
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Indiana University, Emory University
- Investigators
- George Sledge, M.D., Study chair, Hoosier Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232881
- Sponsor's protocol ID
- HOG COE-03
- Status last verified
- Apr 2011
- First submitted
- 1 Nov 2010
- Last updated
- 28 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Response and Toxicity in Patients Receiving Lonafarnib for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study
- ClinicalTrials.gov ID
- NCT01232881
- Acronym / sponsor ID
- HOG COE-03
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: funding terminated
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Hoosier Cancer Research NetworkUniversity, hospital or other
- Collaborators
- United States Department of Defense, Indiana University, Emory University
- Study start
- Aug 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 2 Nov 2010 (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 is a tumor and serum collection study for patients with advanced breast cancer receiving treatment with lonafarnib.
Detailed description
OUTLINE: This is a multi-center study.
Sample Collection:
- Tumor sample
- Serum sample
Treatment Regimen:
- All registered patients must be planning treatment with lonafarnib
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tumor and Serum Collection | – | Procedure: Tumor Sample, Procedure: Serum SampleTumor sample submission can consist of a fresh frozen tissue sample or a formalin-fixed paraffin embedded tissue block. Serum is to be collected prior to the initiation of lonafarnib treatment and 28 days after the last dose of lonafarnib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be limited to patients with advanced breast cancer receiving treatment with lonafarnib.
Key inclusion criteria (4 listed)
- Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age > 18 years.
- Planned treatment with lonafarnib for metastatic breast cancer.
- Must consent to have a biopsy performed to obtain fresh tissue or be able to identify a formalin fixed paraffin embedded (FFPE) tissue block in which tumor samples can be obtained to complete the testing for this study.
Key exclusion criteria (1 listed)
- Planned treatment with any other treatment regimen
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 |
|---|---|---|
| Tumor SampleTumor sample submission can consist of a fresh frozen tissue sample or a formalin-fixed paraffin embedded tissue block. | Procedure or surgery | Tumor and Serum Collection |
| Serum SampleSerum is to be collected prior to the initiation of lonafarnib treatment and 28 days after the last dose of lonafarnib. | Procedure or surgery | Tumor and Serum Collection |
Primary outcome
To correlate tumor gene expression (genomic profile) with response to lonafarnib in patients with advanced breast cancer
Time frame: 24 months
4 secondary outcomes
To correlate serum and tumor proteomic profiles with response to lonafarnib
Time frame: 24 months
To compare serum and tissue proteomic analyses
Time frame: 24 months
To compare genomic and proteomic profiles
Time frame: 24 months
To correlate toxicity and /or response with drug-specific pharmacogenomic parameters
Time frame: 24 months
Results and safety
The study was stopped early (reason given: funding terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2011.
- Hoosier Oncology Group HomepageLink provided by the sponsor.
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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.
George Sledge, M.D. study chair
Hoosier Cancer Research Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Hoosier Cancer Research Network 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 4 inclusion and 1 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 28 Apr 2011. 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 stopped early (reason given: funding terminated). 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?
To correlate tumor gene expression (genomic profile) with response to lonafarnib in patients with advanced breast cancer (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 Apr 2011.