NCT01074814

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Mar 2010

Typical duration for early_phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 24, 2010

Completed
5 days until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
11.2 years until next milestone

Results Posted

Study results publicly available

September 28, 2023

Completed
Last Updated

September 28, 2023

Status Verified

November 1, 2022

Enrollment Period

2.3 years

First QC Date

February 22, 2010

Results QC Date

May 1, 2017

Last Update Submit

November 30, 2022

Conditions

Metastatic Breast Cancer

Keywords

Metastatic Breast CancerMolecular profiling

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Metastatic Breast Cancer Patients

OTHER

Blood drawn for molecular profiling

Drug: Approved therapy will be assigned based on molecular profile and RPMA results

Interventions

Approved therapy will be assigned based on molecular profile and RPMA resultsDRUG

treatment will be assigned based on IHC\< FISH, DNA microarray and RPMA results

Also known as: Approved therapy will be administered based on molecular profile and RPMA results
Metastatic Breast Cancer Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Tgen Clinical Research Services

Scottsdale, Arizona, 85258, United States

Location

Fairfax North Virginia Hematology Oncology

Fairfax, Virginia, 22031, United States

Location

Evergreen Hematology and Oncology

Spokane, Washington, 99218, United States

Location

Related Publications (1)

  • Jameson GS, Petricoin EF, Sachdev J, Liotta LA, Loesch DM, Anthony SP, Chadha MK, Wulfkuhle JD, Gallagher RI, Reeder KA, Pierobon M, Fulk MR, Cantafio NA, Dunetz B, Mikrut WD, Von Hoff DD, Robert NJ. A pilot study utilizing multi-omic molecular profiling to find potential targets and select individualized treatments for patients with previously treated metastatic breast cancer. Breast Cancer Res Treat. 2014 Oct;147(3):579-88. doi: 10.1007/s10549-014-3117-1. Epub 2014 Sep 11.

    PMID: 25209003DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Linda Vocila, Executive Director Clinical Strategy
Organization
Translational Drug Development
lvocila@td2inc.com
6023588311

Study Officials

  • Gayle Jameson, RNMSNACNP-BC

    Scottsdale Healthcare

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2010

First Posted

February 24, 2010

Study Start

March 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

September 28, 2023

Results First Posted

September 28, 2023

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

US(3)