DNA Analysis of Tumor Tissue Samples From Patients With Recurrent or Metastatic Breast Cancer That Expresses HER2
This study is currently recruiting participants.
Verified January 2013 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00897702
First received: May 9, 2009
Last updated: January 14, 2013
Last verified: January 2013
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Purpose
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 ]
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 ]
- 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 ]
Biospecimen Retention: Samples With DNA
Tissue
| Estimated Enrollment: | 173 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
Eligibility| 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.
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897702
Contacts
| Contact: Sarat Chandarlapaty, MD | 646-888-5449 | |
| Contact: Clifford Hudis, MD | 646-888-5449 |
Locations
| 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
Investigators
| 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: | January 14, 2013 |
| 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 Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 21, 2013