DNA Analysis of Tumor Tissue Samples From Patients With Recurrent or Metastatic Breast Cancer That Expresses HER2

This study is currently recruiting participants.
Verified February 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00897702
First received: May 9, 2009
Last updated: February 14, 2014
Last verified: February 2014

May 9, 2009
February 14, 2014
January 2007
January 2015   (final data collection date for primary outcome measure)
  • Comparison of expression levels of PTEN prior to treatment with HER2-targeting agents with levels after disease progression/recurrence [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Mutations relative to known HER2 sequences [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To look for mutations in other druggable oncogenic pathways in tumors progressing on anti-HER2 therapy [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Comparison of expression levels of MUC-4 and PTEN prior to treatment with HER2-targeting agents with levels after disease progression/recurrence [ Designated as safety issue: No ]
  • Mutations relative to known HER2 sequences [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00897702 on ClinicalTrials.gov Archive Site
  • Mutations in the PIK3CA, and PTEN genes [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Comparison of genome-wide expression changes in patients with disease progression after HER2-targeting agents with characteristic profiles of HER2-positive breast cancer [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Shed HER2 extracellular domain in tumors samples obtained after disease progression/recurrence [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To evaluate dynamic proteomic changes in response to inhibition of the RTK/PI3K/ATK/mTOR pathway [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Mutations in the PIK3Ca, PTEN, and epidermal growth factor receptor genes [ Designated as safety issue: No ]
  • Comparison of genome-wide expression changes in patients with disease progression after HER2-targeting agents with characteristic profiles of HER2-positive breast cancer [ Designated as safety issue: No ]
  • HER2 amplification as measured by a novel oligonucleotide microarray-based analysis [ Designated as safety issue: No ]
  • Shed HER2 extracellular domain in tumors samples obtained after disease progression/recurrence [ Designated as safety issue: No ]
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DNA Analysis of Tumor Tissue Samples From Patients With Recurrent or Metastatic Breast Cancer That Expresses HER2
Molecular Mechanisms of Clinical Resistance to Anti-HER2 Therapy Among Patients With HER2 Amplified Breast Cancer

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients respond to treatment.

PURPOSE: This laboratory study is looking at tissue samples from patients with recurrent or metastatic breast cancer that expresses HER2.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

Tissue Blood

Non-Probability Sample

Patients diagnosed with progressive, recurrent or metastatic HER2+ breast cancer.

Breast Cancer
  • Genetic: comparative genomic hybridization
  • Genetic: fluorescence in situ hybridization
  • Genetic: microarray analysis
  • Genetic: mutation analysis
  • Genetic: reverse transcriptase-polymerase chain reaction
  • Other: diagnostic laboratory biomarker analysis
  • Other: immunoenzyme technique
  • Other: immunohistochemistry staining method
  • Procedure: biopsy
  • Procedure: histopathologic examination
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
273
January 2015
January 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients diagnosed with progressive, recurrent or metastatic HER2+ breast cancer and who fulfill the following eligibility criteria will be considered eligible for this study.
  • Patients who previously received treatment with anti-HER2 therapy (including trastuzumab, pertuzumab, TDM1, or lapatinib) as part of adjuvant chemotherapy and now have progressive or recurrent breast cancer, or patients who previously (or currently) received anti-HER2 therapy as part of a regimen for metastatic breast cancer and subsequently experienced evidence of disease progression (e.g. radiologic progression by WHO criteria or new metastasis).
  • Patients with a prior tumor biopsy (may be original) defined as HER2+ by amplification by FISH (>1.9 gene copy number) or IHC 3+.

For the purposes of establishing baselines in some of the assays, separate from the above inclusion criteria, a cohort of patients diagnosed with any recurrent breast cancer will be eligible under the following criteria:

  • Previously received treatment of any kind for breast cancer and now have recurrent breast cancer.

Exclusion Criteria:

  • Patients who are unable to consent to a biopsy.
  • Patients for whom a repeat biopsy would be medically unsafe
Both
Not Provided
No
Contact: Sarat Chandarlapaty, MD 646-888-5449
Contact: Clifford Hudis, MD 646-888-5449
United States
 
NCT00897702
06-163, MSKCC-06163
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Sarat Chandarlapaty Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP