Breast Cancer Clinical Trial
Genomic and Proteomic Profiling Targets Influenced Treatment in Metastatic Breast Cancer
Summary
The primary objective is to examine the impact on progression-free survival of targeted therapy for breast cancer suggested by proteomic and genomic profiling.
Full Description
To explore the impact of targeted therapy for breast cancer suggested by proteomic and genomic profiling using RPMA, targeted resequencing, IHC analysis, WGS, RNA-seq, and Exome sequencing on progression-free survival. When a molecular target cannot be identified, the patient will be treated with a therapy selected on an empirical basis by the investigator/treating physician at the individual site and will be followed for survival status. Only available, FDA-approved agents will be used.
Eligibility Criteria
Inclusion Criteria:
Life expectancy of >3 months
Diagnosis of metastatic breast cancer or an advanced gynecological malignancy with measurable disease
Age greater than or equal to 18 years
ECOG performance status of 0-1
Able to undergo two biopsies to obtain tissue with first biopsy required and second biopsy optional
Have failed or unable to tolerate previous treatment regimen
Adequate organ and bone marrow function as defined by ANC ≥ 1.5 x 109/L; Hgb 9 g/dL; platelets greater than 100 x 109/L; creatinine ≤ 1.5 mg/dL; bilirubin ≤ 2.5 x ULN; AST and ALT ≤ 2.5 x ULN (or ≤ 5 x ULN if due to underlying liver metastases); INR ≤ 1.5 x ULN (except in the case of anticoagulation therapy)
Exclusion Criteria:
Metastatic lesions that are not accessible to biopsy
Symptomatic CNS metastasis
Previous history of another malignancy within 5 years of study entry
Uncontrolled concurrent illness
Known HIV, HBB, and/or HCV infection
Pregnant or breast feeding or childbearing potential and not using adequate birth control
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There is 1 Location for this study
Sioux Falls South Dakota, 57105, United States
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