Sioux Falls, South Dakota 57105


Purpose:

The primary objective is to examine the impact on progression-free survival of targeted therapy for breast cancer suggested by proteomic and genomic profiling.


Study summary:

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.


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


NCT ID:

NCT02470819


Primary Contact:

Principal Investigator
Brian Leyland-Jones, MD
Avera McKennan

Brian Leyland-Jones, MD
Phone: 605-322-6900
Email: brian.leylandjones@avera.org


Backup Contact:

Email: casey.williams@avera.org
Casey Williams, PharmD
Phone: 605-322-6900


Location Contact:

Sioux Falls, South Dakota 57105
United States

Brian Leyland-Jones, MD
Phone: 605-322-6900
Email: brian.leylandjones@avera.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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