IMAGE Study: Personalized Molecular Profiling in Cancer Treatment at Johns Hopkins

Completed · Not applicable

Conditions studied: Metastatic Breast Cancer

In brief

This study will test the feasibility of identifying patients who could benefit from tumor molecular profiling, of analyzing the patients' tumors in a timely (28 day) fashion, and of the identification of possible actionable mutations that are not just biologically interesting but are clinically relevant. The investigators will also examine the outcome data from patients who followed the Molecular Profiling Tumor Board suggestion compared with those who did not. When the tissue studies are done, an additional group of patients will be enrolled to test if the same is possible in blood samples.

Key facts

Study ID

NCT01939847

Run by

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

People needed

32

Starts

2013-09-19

Expected to finish

2017-02-01

Last updated by the study team

2019-02-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or Female
• 18 years of age or older
• Metastatic breast cancer and treatment with prior chemotherapy (either in adjuvant, neoadjuvant or metastatic setting)
• Triple negative clinical phenotype (ER-, PR-, HER2-). For HER2 assessment, a negative result is an immunohistochemical (IHC staining of 0 or 1+, a FISH result of less than 4.0 HER2 gene copies per nucleus, or a FISH ratio of less than 1.8. ER/PR will be assessed by IHC and will be defined as positive/negative using the American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) Guidelines. Estrogen receptor (ER) and progesterone receptor (PR) assays will be considered positive if there are at least 1% positive tumor nuclei in the sample on testing in the presence of expected reactivity of internal (normal epithelial elements) and external controls. NOTE: A triple negative clinical phenotype based upon the patient's clinical course may also be eligible as determined at the discretion of the Study Chair (ie, if a patient is behaving clinically as ER/PR negative but does not meet the strict criteria outlined.)
• Patients must have a tumor suitable for biopsy and be deemed medically appropriate to undergo a biopsy
• Able to voluntarily provide informed consent

You may not qualify if…

• N/A
• MOLECULAR PROFILING IN BLOOD:
• Inclusion Criteria:
• Male or Female
• 18 years of age or older
• Metastatic breast cancer
• Any phenotype of breast cancer is eligible for enrollment (i.e., any ER, PR, and HER2 status).
• Able to voluntarily provide informed consent
• Exclusion Criteria:
• N/A

Where it is running

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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