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

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

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.

Condition Intervention
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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Molecular Mechanisms of Clinical Resistance to Anti-HER2 Therapy Among Patients With HER2 Amplified Breast Cancer

Resource links provided by NLM:

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Tissue Blood

Estimated Enrollment: 273
Study Start Date: January 2007
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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


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
  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: NCT00897702

Contact: Sarat Chandarlapaty, MD 646-888-5449
Contact: Clifford Hudis, MD 646-888-5449

United States, New Jersey
Memorial Sloan-Kettering at Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Sarat Chandarlapaty, MD    646-888-5449      
United States, New York
Memorial Sloan-Kettering Cancer Center @ Suffolk Recruiting
Commack, New York, United States, 11725
Contact: Sarat Chandarlapaty, MD    646-888-5449      
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Sarat Chandarlapaty, MD    646-888-5449      
Memorial Sloan-Kettering Cancer Center at Mercy Medical Center Recruiting
Rockville Centre, New York, United States, 11570
Contact: Sarat Chandarlapaty, MD    646-888-5449      
Memoral Sloan Kettering Cancer Center@Phelps Recruiting
Sleepy Hollow, New York, United States
Contact: Sarat Chandarlapaty, MD    646-888-5449      
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Study Chair: Sarat Chandarlapaty Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00897702     History of Changes
Other Study ID Numbers: 06-163, MSKCC-06163
Study First Received: May 9, 2009
Last Updated: August 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
recurrent breast cancer
male breast cancer
stage IV breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 21, 2014