Lapatinib Resistance in Patients With Breast Cancer

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00898573
First received: May 9, 2009
Last updated: June 10, 2010
Last verified: June 2010
  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

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

Locations
United States, Ohio
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Geauga Regional Hospital
Cleveland, Ohio, United States, 44024
Lake/University Ireland Cancer Center
Cleveland, Ohio, United States, 44060
Mercy Cancer Center at Mercy Medical Center
Cleveland, Ohio, United States, 44708
Southwest General Health Center
Cleveland, Ohio, United States, 44130
UHHS Chagrin Highlands Medical Center
Cleveland, Ohio, United States, 44122
UHHS Westlake Medical Center
Cleveland, Ohio, United States, 44145
University Suburban Health Center
Cleveland, Ohio, United States, 44121
Sponsors and Collaborators
Case Comprehensive Cancer Center
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

No publications provided

Responsible Party: Balazs Halmos. MD, Ireland Cancer Center at University Hospitals Case Medical Center, 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: June 10, 2010
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
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014