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Status:

WITHDRAWN

Lapatinib Resistance in Patients With Breast Cancer

Lead Sponsor:

Case Comprehensive Cancer Center

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Breast Cancer

Eligibility:

All Genders

Brief 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:...

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 chang...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    July 1 2008

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT00898573

    Start Date

    July 1 2008

    Last Update

    October 2 2015

    Active Locations (9)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (9 locations)

    1

    Geauga Regional Hospital

    Cleveland, Ohio, United States, 44024

    2

    Lake/University Ireland Cancer Center

    Cleveland, Ohio, United States, 44060

    3

    Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

    Cleveland, Ohio, United States, 44106-5065

    4

    University Suburban Health Center

    Cleveland, Ohio, United States, 44121