Molecular Mechanisms of Clinical Resistance to Targeted Therapy Among Patients With Breast Cancer
NCT ID: NCT00897702
Last Updated: 2025-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
269 participants
OBSERVATIONAL
2007-01-09
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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Blood draw
A single 10ml tube of blood will also be obtained for a comparison of patient's normal DNA for genomic analyses either at the time of the procedure or at a followup appointment if feasible.
immunoenzyme technique
biopsy
histopathologic examination
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with breast cancer.
* Patient must be able to consent to a biopsy
* Patient must be able to safely undergo a secondary biopsy, if needed.
Cohort 1
* Patients who previously received treatment with anti-HER2 therapy (including trastuzumab, pertuzumab, TDM1, lapatinib, neratibin, or DS8201) 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 or recurrence after prior therapy (e.g. radiologic progression by RECIST criteria or new metastasis).
* Prior tumor biopsy (may be original) defined as HER2+ by amplification by FISH (\>1.9 gene copy number) or IHC 3+.
Cohort 2
* Patients who previously received treatment with hormonal therapy (including aromatase inhibitors or SERMs or SERDs) as a part of adjuvant therapy and now have progressive or recurrent breast cancer or patients who previously (or currently) receive hormonal therapy as part of a regimen for metastatic breast cancer and subsequently experienced evidence of disease progression.
Cohort 3
* Patients not eligible for Cohorts 1 or 2.
Exclusion Criteria
* Patients for whom a repeat biopsy would be medically unsafe
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Sarat Chandarlapaty, MD, PhD
Role: STUDY_CHAIR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Basking Ridge (Consent only)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Consent only)
Montvale, New Jersey, United States
Memorial Sloan Kettering Commack (Consent only)
Commack, New York, United States
Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Nassau (Consent only)
Uniondale, New York, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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MSKCC-06163
Identifier Type: -
Identifier Source: secondary_id
06-163
Identifier Type: -
Identifier Source: org_study_id
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