Back to resultsGenomic and Proteomic Profiling Targets Influenced Treatment in Metastatic Breast Cancer
Primary Purpose
Metastatic Breast Cancer, Breast Tumor, Advanced Gynecologic Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Genetic profiling
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Breast Cancer
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
Sites / Locations
- Avera Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Targeted Therapy
Arm Description
Those who will receive targeted therapy based on their genetic profiling
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02470819
First Posted
June 9, 2015
Last Updated
November 6, 2018
Sponsor
Avera McKennan Hospital & University Health Center
1. Study Identification
Unique Protocol Identification Number
NCT02470819
Brief Title
Genomic and Proteomic Profiling Targets Influenced Treatment in Metastatic Breast Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Investigator elected to end the study
Study Start Date
March 2014 (undefined)
Primary Completion Date
October 30, 2018 (Actual)
Study Completion Date
October 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avera McKennan Hospital & University Health Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer, Breast Tumor, Advanced Gynecologic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Targeted Therapy
Arm Type
Experimental
Arm Description
Those who will receive targeted therapy based on their genetic profiling
Intervention Type
Genetic
Intervention Name(s)
Genetic profiling
Intervention Description
genetic profiling
Primary Outcome Measure Information:
Title
Progression-free survival
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Tumor assessment
Description
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.
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Leyland-Jones, MD
Organizational Affiliation
Avera McKennan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Avera Cancer Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Genomic and Proteomic Profiling Targets Influenced Treatment in Metastatic Breast Cancer
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