Official Title
Molecular Mechanisms of Clinical Resistance to Targeted Therapy Among Patients With Breast Cancer
Brief Title
Molecular Mechanisms of Clinical Resistance to Targeted Therapy Among Patients With Breast Cancer
Protocol ID
NCT00897702
Lead Sponsor
Memorial Sloan Kettering Cancer Center
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 stops working. However, we do not know if the same molecules
change in patients. This study is being done to see if they do change. If we learn more
about how patients become resistant, we may be able to offer better treatment in the
future.
Study Period
-
Enrollment Count
269 participants
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
- Patients who are unable to consent to a biopsy.
- Patients for whom a repeat biopsy would be medically unsafe
Filters
Breast Cancer
COMPLETED
CHILD
ADULT
OLDER_ADULT