Pilot Study Using Molecular Profiling to Find Potential Targets & Select Treatments for Pts With Met br ca (Side-Out)

November 30, 2022 updated by: Translational Drug Development

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Tgen Clinical Research Services
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Fairfax North Virginia Hematology Oncology
    • Washington
      • Spokane, Washington, United States, 99218
        • Evergreen Hematology and Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Metastatic Breast Cancer Patients
Blood drawn for molecular profiling
Drug: Approved therapy will be assigned based on molecular profile and RPMA results
treatment will be assigned based on IHC< FISH, DNA microarray and RPMA results
Other Names:
  • Approved therapy will be administered based on molecular profile and RPMA results

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Growth Modulation Index (GMI) Greater Than or Equal to 1.3
Time Frame: 6-20 weeks
The primary objective was to determine the % of patients with refractory breast cancer where MMP-informed selection of approved cancer therapies could change the clinical course of their disease to produce a Growth Modulation Index (GMI) greater than 1.3. The GMI was calculated as the PFS with MMP-selected therapy/time to progression (TTP) on last prior therapy. A GMI of 1.3 was selected because 30% or greater improvement in PFS with MMP-selected therapy compared to previous TTP would be considered clinically meaningful.
6-20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Translational Drug Development

Collaborators

Side-Out Foundation

Investigators

  • Principal Investigator: Gayle Jameson, RNMSNACNP-BC, Scottsdale Healthcare

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

February 22, 2010

First Submitted That Met QC Criteria

February 23, 2010

First Posted (Estimated)

February 24, 2010

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

November 30, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SO-BCA-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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