Pilot Study Using Molecular Profiling to Find Potential Targets & Select Treatments for Pts With Met br ca

Metastatic Breast Cancer Clinical Trial

— Side-Out  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01074814
• Other study ID #: SO-BCA-001
• Status: Completed
• Phase: Early Phase 1
• Start date: March 2010
• Est. completion date: July 2012

Study information

• Verified date: November 2022
• Source: Translational Drug Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

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

Locations

Country	Name	City	State
United States	Fairfax North Virginia Hematology Oncology	Fairfax	Virginia
United States	Tgen Clinical Research Services	Scottsdale	Arizona
United States	Evergreen Hematology and Oncology	Spokane	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Translational Drug Development	Side-Out Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth Modulation Index (GMI) Greater Than or Equal to 1.3	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