Molecular Mechanisms of Clinical Resistance to Targeted Therapy Among Patients With Breast Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Breast Cancer

Treatments: Other: Blood draw; Other: immunoenzyme technique; Procedure: histopathologic examination; Procedure: biopsy

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00897702

06-163

MSKCC-06163

Details and patient eligibility

About

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.

Enrollment: 269 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design