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Genomic and Proteomic Profiling Targets Influenced Treatment in Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02470819
Recruitment Status : Withdrawn (Investigator elected to end the study)
First Posted : June 12, 2015
Last Update Posted : November 7, 2018
Information provided by (Responsible Party):
Avera McKennan Hospital & University Health Center

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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Breast Tumor Advanced Gynecologic Cancer Genetic: Genetic profiling Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2014
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : October 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Targeted Therapy
Those who will receive targeted therapy based on their genetic profiling
Genetic: Genetic profiling
genetic profiling

Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 4 months ]
    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 :
  1. Tumor assessment [ Time Frame: 4 months ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02470819

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United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Sponsors and Collaborators
Avera McKennan Hospital & University Health Center
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Principal Investigator: Brian Leyland-Jones, MD Avera McKennan

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Responsible Party: Avera McKennan Hospital & University Health Center Identifier: NCT02470819     History of Changes
Other Study ID Numbers: AMEM-2014-DOD001
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases