Status:
ACTIVE_NOT_RECRUITING
Molecular Mechanisms of Clinical Resistance to Targeted Therapy Among Patients With Breast Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
All Genders
Brief Summary
The purpose of this study is to learn why certain drugs stop working in patients.In lab studies, tumors become resistant in several ways. Specific molecules seem to change and this may be why therapy ...
Eligibility Criteria
Inclusion
- All patients:
- 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
- Patients who are unable to consent to a biopsy.
- Patients for whom a repeat biopsy would be medically unsafe
Key Trial Info
Start Date :
January 9 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2026
Estimated Enrollment :
269 Patients enrolled
Trial Details
Trial ID
NCT00897702
Start Date
January 9 2007
End Date
January 1 2026
Last Update
March 4 2025
Active Locations (7)
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1
Memorial Sloan Kettering Basking Ridge (Consent only)
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Bergen (Consent only)
Montvale, New Jersey, United States, 07645
4
Memorial Sloan Kettering Commack (Consent only)
Commack, New York, United States, 11725