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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.


N/A
18 Years
N/A
Not Enrolling
Both
Metastatic Breast Cancer

Thank you

Trial Information

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.


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to progression

Outcome Description:

disease status will be accessed every 6-8 weeks while on treatment.

Outcome Time Frame:

6-8 weeks

Safety Issue:

No

Principal Investigator

Gayle Jameson, MSN, ACNP-BC, AOCN

Investigator Role:

Principal Investigator

Investigator Affiliation:

Scottsdale Healthcare

Authority:

United States: Institutional Review Board

Study ID:

SO-BCA-001

NCT ID:

NCT01074814

Start Date:

February 2010

Completion Date:

July 2012

Related Keywords:

  • Metastatic Breast Cancer
  • Metastatic Breast Cancer
  • Molecular profiling
  • Breast Neoplasms

Name

Location

TGen Clinical Research ServicesScottsdale, Arizona  85258
Evergreen Hematology And OncologySpokane, Washington  99218
Fairfax North Virginia Hematology OncologyFairfax, Virginia  22031