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Pilot Study Using Molecular Profiling to Find Potential Targets and Select Treatments for Patients With Metastatic Breast Cancer. (Side-Out)

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ClinicalTrials.gov Identifier: NCT01074814
Recruitment Status : Completed
First Posted : February 24, 2010
Last Update Posted : August 28, 2013
SideOut Foundation
Information provided by:
Translational Drug Development

Brief Summary:
The purpose of this study is to determine the response rate, that is the % of patients with non-progression of their metastatic breast cancer after 4 months on treatment that was selected by molecular testing and proteomics.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: (will be assigned based on molecular profile and RPMA) Not Applicable

Detailed Description:
To determine the percent of patients with refractory breast cancer where molecular profiling and RPMA-based protein pathway activation analysis of their tumor, can change the clinical course of their disease (i.e. produce a Growth Modulation Index (GMI) ≥1.3). The GMI is calculated as the ratio of Progression-free survival (PFS) under molecular profiling and RPMA analysis selected treatment to the time to progression (TTP) for the most recent regimen the patient has progressed on.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study Utilizing Molecular Profiling by IHC, FISH, DNA Microarray, and Reverse Phase Protein Microarray (RPMA) of Patients' Tumors to Find Potential Targets and Select Treatments for Patients With Metastatic Breast Cancer.
Study Start Date : February 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Intervention Details:
  • Drug: (will be assigned based on molecular profile and RPMA)
    treatment will be assigned based on IHC< FISH, DNA microarray and RPMA results

Primary Outcome Measures :
  1. Time to progression [ Time Frame: 6-8 weeks ]
    disease status will be accessed every 6-8 weeks while on treatment.

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:

  • Have a life expectancy of greater than 3 months
  • metastatic breast cancer, with measurable or evaluable non-measurable disease
  • Have progressed on at least 3 prior chemotherapeutic or biological regimens
  • Be defined as refractory to the last line of therapy according to the following criteria: Documented disease progression under the last treatment or within two months of the last treatment dosing AND Have received ≥ 30 days of the last treatment AND Have discontinued for progression by RECIST 1.1 criteria
  • ≥18 years of age
  • ECOG 0-1
  • willing to undergo a biopsy or surgical procedure to obtain tissue
  • Must have been off their prior regimen for ≥ 3 weeks or 5 x half life of drug
  • Have adequate organ and bone marrow function as defined below:
  • Female patients of child-bearing potential must have a negative pregnancy test and agree to use at least one form of contraception during the study and for at least one month after treatment discontinuation. For the purposes of this study, child-bearing potential is defined as: all female patients unless they are post-menopausal for at least one year or are surgically sterile
  • Male patients must use a form of barrier contraception approved by the Investigator during the study and for at least one month after treatment discontinuation.

Exclusion Criteria:

  • Tumor biopsy intended for use in the current study which was performed more than 2 months prior
  • Frozen material is not available/obtained
  • Metastatic lesion is not accessible to biopsy
  • Patients with > 6 months treatment under the last line of therapy
  • Patients with symptomatic CNS metastasis. Patients with a history of CNS metastases who have been treated must be stable without symptoms for 4 weeks after completion of treatment, with image documentation required, and must be either off steroids or on a stable dose of steroids for ≥ 2 weeks prior to enrollment
  • Any previous history of another malignancy (other than cured basal cell carcinoma of the skin or cured in-situ carcinoma of the cervix) within 5 years of study entry
  • Uncontrolled concurrent illness including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina pectoris, unstable cardiac arrhythmias, psychiatric illness, or situations that would limit compliance with the study requirements or the ability to willingly give written informed consent
  • Known HIV, HBV, HCV infection
  • Pregnant or breast-feeding patients or any patient with childbearing potential not using adequate contraception.

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 ClinicalTrials.gov identifier (NCT number): NCT01074814

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United States, Arizona
Tgen Clinical Research Services
Scottsdale, Arizona, United States, 85258
United States, Virginia
Fairfax North Virginia Hematology Oncology
Fairfax, Virginia, United States, 22031
United States, Washington
Evergreen Hematology and Oncology
Spokane, Washington, United States, 99218
Sponsors and Collaborators
Translational Drug Development
SideOut Foundation
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Principal Investigator: Gayle Jameson, MSN, ACNP-BC, AOCN Scottsdale Healthcare
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gayle S. Jameson, MSN, ACNP-BC, AOCN, Tgen Clinical Research Services at Scottsdale Healthcare
ClinicalTrials.gov Identifier: NCT01074814    
Other Study ID Numbers: SO-BCA-001
First Posted: February 24, 2010    Key Record Dates
Last Update Posted: August 28, 2013
Last Verified: July 2012
Keywords provided by Translational Drug Development:
Metastatic Breast Cancer
Molecular profiling
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases