Genomic and Proteomic Profiling Targets Influenced Treatment in Metastatic Breast Cancer

Study Overview
=================
Brief 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.

Detailed 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.

Official Title
-----------------
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

Conditions
-----------------
Metastatic Breast Cancer, Breast Tumor, Advanced Gynecologic Cancer

Intervention / Treatment
-----------------
* Genetic: Genetic profiling


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Targeted Therapy<br>Those who will receive targeted therapy based on their genetic profiling | Genetic: Genetic profiling<br>* genetic profiling<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Progression-free survival will be defined as the interval between the first dose of therapy and the occurrence of disease progression (fatal or non-fatal). Disease status will be assessed every 7 +/- 1 week until progression or time of treatment discontinuation, whichever is later. If progression is not observed at the end of therapy, patients will be assessed every 3 months until progression or further anti-cancer therapy. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor assessment | Radiographic response will be evaluated according to RECIST 1.1 criteria in all patients with measurable disease. All sites of disease must be evaluated using the baseline assessment methods. Confirmatory assessment of complete response or partial response must be performed no less than 4 weeks after the initial documentation of response. | 4 months |