Lapatinib Resistance in Patients With Breast Cancer

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00898573
First received: May 9, 2009
Last updated: October 1, 2015
Last verified: October 2015
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: lapatinib ditosylate
Genetic: fluorescence in situ hybridization
Genetic: gene expression analysis
Genetic: mutation analysis
Genetic: polymerase chain reaction
Genetic: reverse transcriptase-polymerase chain reaction
Other: cell sorting
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Phase 1

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Study of Resistance Mechanisms Against Lapatinib in Patients With ErbB-2-Positive Breast Cancers

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Secondary ErbB2 mutations [ Designated as safety issue: No ]
  • ErbB2 copy number changes and expression levels [ Designated as safety issue: No ]
  • Abnormalities of other pathways (e.g., c-MET and PI3K) as potential mechanisms of resistance [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Previously collected tumor tissue samples are obtained for genetic analysis studies. Patients also undergo blood sample collection for extraction of DNA.

Enrollment: 0
Study Start Date: July 2008
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.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary care clinic
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00898573

Locations
United States, Ohio
Geauga Regional Hospital
Cleveland, Ohio, United States, 44024
Lake/University Ireland Cancer Center
Cleveland, Ohio, United States, 44060
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
University Suburban Health Center
Cleveland, Ohio, United States, 44121
UHHS Chagrin Highlands Medical Center
Cleveland, Ohio, United States, 44122
Southwest General Health Center
Cleveland, Ohio, United States, 44130
UHHS Westlake Medical Center
Cleveland, Ohio, United States, 44145
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Mercy Cancer Center at Mercy Medical Center
Cleveland, Ohio, United States, 44708
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Thomas Budd, MD Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Principal Investigator: Balazs Halmos, MD Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
  More Information

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00898573     History of Changes
Other Study ID Numbers: CASE15107  P30CA043703  CASE15107  CASE-15107-CC488 
Study First Received: May 9, 2009
Last Updated: October 1, 2015
Health Authority: United States: Federal Government

Keywords provided by Case Comprehensive Cancer Center:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Lapatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 25, 2016