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

Translational Drug Development (TD2)

Status and phase

Completed

Early Phase 1

Conditions

Metastatic Breast Cancer

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01074814

SO-BCA-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.