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Study of Resistance Mechanisms Against Lapatinib in Patients With ErbB-2-Positive Breast Cancers


Phase 1
N/A
N/A
Not Enrolling
Both
Breast Cancer

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Trial Information

Study of Resistance Mechanisms Against Lapatinib in Patients With ErbB-2-Positive Breast Cancers


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.

Inclusion 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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Outcome Measure:

Secondary ErbB2 mutations

Safety Issue:

No

Principal Investigator

Thomas Budd, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CASE15107

NCT ID:

NCT00898573

Start Date:

July 2008

Completion Date:

Related Keywords:

  • Breast Cancer
  • breast cancer
  • Breast Neoplasms

Name

Location

Mercy Cancer Center at Mercy Medical CenterCanton, Ohio  44708
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Lake/University Ireland Cancer CenterMentor, Ohio  44060
Geauga Regional HospitalChardon, Ohio  44024
Southwest General Health CenterMiddleburgh Heights, Ohio  44130
UHHS Chagrin Highlands Medical CenterOrange Villager, Ohio  44122
University Suburban Health CenterSouth Euclid, Ohio  44121
UHHS Westlake Medical CenterWestlaker, Ohio  44145
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterCleveland, Ohio  44195