Breast CancerNCT00898573
Lapatinib Resistance in Patients With Breast Cancer
An observational study of Breast Cancer, run by Case Comprehensive Cancer Center at 9 sites in United States.
Trial summary
RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about cancer and the development of drug resistance in patients. PURPOSE: This research study is looking at lapatinib resistance in patients with breast cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer
- What is being tested?
- lapatinib ditosylate, fluorescence in situ hybridization and gene expression analysis
- How many people
- 0 participants
- Where
- 9 sitesUnited States
- Study dates
- Jul 2008to not given
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Primary care clinic
DISEASE CHARACTERISTICS:
- Pathologically confirmed invasive breast cancer
- ErbB2-positive disease
- Has received or is currently receiving lapatinib ditosylate
- Documented clinical benefit while receiving lapatinib ditosylate (e.g., stable disease of ≥ 12 weeks duration OR a radiographic response)
- Must have tumor tissue samples available for research studies
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- Not pregnant*
- Coagulation profile normal*
- Platelet count > 100,000/mm³* NOTE: *For patients requiring a post-treatment biopsy
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Concurrent chemotherapy or trastuzumab (Herceptin®) allowed
- No concurrent anticoagulants, including warfarin or low-molecular weight heparin*
- No concurrent antiplatelet therapy, including aspirin, clopidogrel, or other antiplatelet agents* NOTE: *For patients requiring a post-treatment biopsy
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Geauga Regional Hospital
Cleveland, Ohio, 44024
Lake/University Ireland Cancer Center
Cleveland, Ohio, 44060
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
University Suburban Health Center
Cleveland, Ohio, 44121
UHHS Chagrin Highlands Medical Center
Cleveland, Ohio, 44122
Southwest General Health Center
Cleveland, Ohio, 44130
UHHS Westlake Medical Center
Cleveland, Ohio, 44145
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
Mercy Cancer Center at Mercy Medical Center
Cleveland, Ohio, 44708
About this study
Official title: Study of Resistance Mechanisms Against Lapatinib in Patients With ErbB-2-Positive Breast Cancers
RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about cancer and the development of drug resistance in patients.
PURPOSE: This research study is looking at lapatinib resistance in patients with breast cancer.
Read the detailed description
OBJECTIVES:
- To identify secondary ErbB2 mutations in tumor tissue samples from patients with ErbB2-positive breast cancer treated with lapatinib ditosylate.
- To investigate ErbB2 copy number changes and expression levels.
- To determine abnormalities of other pathways (e.g., c-MET and PI3K) as potential mechanisms of resistance.
OUTLINE: Previously collected tumor tissue samples* are obtained for genetic analysis studies. Samples are analyzed for secondary ErbB2 mutations by nested PCR; ErbB2 copy number changes by quantitative PCR and standard histological FISH; and ErbB2 expression levels by quantitative RT-PCR and IHC. Patients also undergo blood sample collection for extraction of DNA (as normal control DNA) and isolation of EpCAM-positive circulating tumor cells using immunomagnetic cell separation technology. Additional research studies may include mutational and amplification analysis of the c-MET and PI3K pathways.
NOTE: *Patients may undergo biopsy if a post-treatment tumor tissue sample is unavailable.
- Conditions
- Breast Cancer
- Being tested
- lapatinib ditosylate, fluorescence in situ hybridization, gene expression analysis, mutation analysis, polymerase chain reaction
- Keywords
- 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.
lapatinib ditosylateDrug
fluorescence in situ hybridizationGenetic
gene expression analysisGenetic
mutation analysisGenetic
polymerase chain reactionGenetic
reverse transcriptase-polymerase chain reactionGenetic
cell sortingOther
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Secondary ErbB2 mutations
ErbB2 copy number changes and expression levels
Abnormalities of other pathways (e.g., c-MET and PI3K) as potential mechanisms of resistance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startJul 2008
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.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Thomas Budd, MD, Principal investigator, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterBalazs Halmos, MD, Principal investigator, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00898573
- Sponsor's protocol ID
- CASE15107
- Other IDs
- P30CA043703, CASE15107, CASE-15107-CC488
- Status last verified
- Oct 2015
- First submitted
- 9 May 2009
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Resistance Mechanisms Against Lapatinib in Patients With ErbB-2-Positive Breast Cancers
- ClinicalTrials.gov ID
- NCT00898573
- Acronym / sponsor ID
- CASE15107
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2008
- First posted
- 12 May 2009 (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.
RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about cancer and the development of drug resistance in patients.
PURPOSE: This research study is looking at lapatinib resistance in patients with breast cancer.
Detailed description
OBJECTIVES:
- To identify secondary ErbB2 mutations in tumor tissue samples from patients with ErbB2-positive breast cancer treated with lapatinib ditosylate.
- To investigate ErbB2 copy number changes and expression levels.
- To determine abnormalities of other pathways (e.g., c-MET and PI3K) as potential mechanisms of resistance.
OUTLINE: Previously collected tumor tissue samples* are obtained for genetic analysis studies. Samples are analyzed for secondary ErbB2 mutations by nested PCR; ErbB2 copy number changes by quantitative PCR and standard histological FISH; and ErbB2 expression levels by quantitative RT-PCR and IHC. Patients also undergo blood sample collection for extraction of DNA (as normal control DNA) and isolation of EpCAM-positive circulating tumor cells using immunomagnetic cell separation technology. Additional research studies may include mutational and amplification analysis of the c-MET and PI3K pathways.
NOTE: *Patients may undergo biopsy if a post-treatment tumor tissue sample is unavailable.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary care clinic
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 |
|---|---|---|
| lapatinib ditosylate | Drug | – |
| fluorescence in situ hybridization | Genetic | – |
| gene expression analysis | Genetic | – |
| mutation analysis | Genetic | – |
| polymerase chain reaction | Genetic | – |
| reverse transcriptase-polymerase chain reaction | Genetic | – |
| cell sorting | Other | – |
| immunohistochemistry staining method | Other | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Secondary ErbB2 mutations
ErbB2 copy number changes and expression levels
Abnormalities of other pathways (e.g., c-MET and PI3K) as potential mechanisms of resistance
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 2 Oct 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.
Thomas Budd, MD principal investigator
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Balazs Halmos, MD principal investigator
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
9 sites 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 Case Comprehensive Cancer Center at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 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?
Secondary ErbB2 mutations. The study lists 3 primary outcomes in all. 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 2 Oct 2015.