Pilot Study Using Molecular Profiling to Find Potential Targets and Select Treatments for Patients With Metastatic Breast Cancer.

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01074814
• Date of registration: 22/02/2010
• Primary sponsor: TGen Drug Development Services
• Public title: Pilot Study Using Molecular Profiling to Find Potential Targets and Select Treatments for Patients With Metastatic Breast Cancer. Side-Out
• Scientific 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.
• Date of first enrolment: February 2010
• Target sample size: 25
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01074814
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Gayle Jameson, MSN, ACNP-BC, AOCN
• Affiliation: Scottsdale Healthcare

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Metastatic Breast Cancer

Intervention(s)

Drug: (will be assigned based on molecular profile and RPMA)

Primary Outcome(s)

Time to progression [Time Frame: 6-8 weeks]

Secondary ID(s)

SO-BCA-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

SideOut Foundation