Genomic and Proteomic Profiling Targets Influenced Treatment in Metastatic Breast Cancer



Status:Withdrawn
Conditions:Breast Cancer, Cervical Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/9/2018
Start Date:March 2014
End Date:October 30, 2018

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A Two Arm Pilot Study Utilizing Molecular Profiling to Find Potential Targets and Influence Treatments for Patients With Metastatic Breast Cancer or Advanced Gynecological Malignancies

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

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.

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
We found this trial at
1
site
3900 W Avera Drive
Sioux Falls, South Dakota 57108
(605) 322-4700
Phone: 605-322-6900
Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
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mi
from
Sioux Falls, SD
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