Clinical trial NCT01939847: IMAGE Study: Personalized Molecular Profiling in Cancer Treatment at Johns Hopkins
Official title: IMAGE Study: Individualized Molecular Analyses Guide Efforts in Breast Cancer - Personalized Molecular Profiling in Cancer Treatment at Johns Hopkins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Breast Cancer
Keywords: Metastatic breast cancer
Breast cancer
Molecular profiling
Personalized medicine
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Foundation Medicine
First posted: 2013-09-11
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The goal of this research study is to determine if it is possible to obtain personalized genetic information from a subject's tumor to see if physicians can use that information to make a treatment suggestion. The investigators hope to identify genes important to cancer cells that could potentially identify a more educated way to recommend therapy. It is not known if our suggestion for treatment based on genetic information will be the correct treatment choice.

Subjects and their treating doctor will have a choice about what treatment they will receive and do not have to decide to be treated with the suggestion from this study. In some cases it will not be possible to make a suggestion. For example, a suggestion for treatment will not be possible if there are technical issues, if the gene sequencing process takes longer than planned, or if no genes are identified that could help identify a treatment suggestion.

The investigators also plan to collect information about the treatment subjects receive and how their cancer responds to the treatment. This may help us to understand if our personalized suggestion improves the amount of time before their disease progresses.

In addition, blood samples will be collected for research studies. These samples are being collected to learn more about breast cancer by studying cells, genes, and gene products including their patterns and changes in the blood and tissue to help to learn how cancer develops and responds to therapy.

Any man or woman being seen at Johns Hopkins for treatment of metastatic triple negative (or behaving as triple negative) breast cancer may be eligible.

Upon conclusion of the tissue studies and in order to gain experience with and assess the feasibility of receiving blood-based results using blood sampling kits, we will enroll an additional cohort of patients with recent Foundation Medicine testing for clinical purposes and collect blood samples only for research testing. The primary objectives and analysis for this new cohort will proceed similarly as the original tissue-based cohort.

Eligibility criteria: MOLECULAR PROFILING IN TISSUE:

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Time to report molecular profiling in tissue
timeFrame: 28 days
measure: Time to report molecular profiling in blood
timeFrame: 28 days
Secondary outcomes:
measure: Ability to make treatment suggestions
timeFrame: 28 days
measure: Decisions about Molecular Profiling Tumor Board (MPTB) suggestion
timeFrame: 1 year
measure: Progression-free survival
timeFrame: 1 year
measure: Changes in plasma tumor DNA (ptDNA)
timeFrame: 1 year
measure: Similarities and differences of the profiling results with the different assays in tissue
timeFrame: 1 year
Other outcomes:
measure: Similarities and differences of the profiling assay results between blood and tissue samples
timeFrame: 1 year
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Vered Stearns, MD
role: PRINCIPAL_INVESTIGATOR
References: