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

Not Applicable

Completed

• Conditions: Metastatic Breast Cancer
• Interventions: Other: Treatment suggestion

• Registration Number: NCT01939847
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

Study Timeline

• Study First Submitted: 2013-09-03
• Study First Submitted QC: 2013-09-06
• Study First Posted: 2013-09-11
• Study Start: 2013-09-19
• Primary Completion: 2015-05-14
• Study Completion: 2017-02-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-27
• Last Update Posted: 2019-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Molecular prolfiling in tissue	Treatment suggestion	Participant's tumor will be analyzed by Foundation Medicine on their FoundationOne platform - a targeted whole exome sequencing of 182 cancer related genes (3,230 exons) as well as 37 introns from 14 genes commonly rearranged or altered in cancer via next-generation sequencing technology to provide a molecular profile for a possible treatment suggestion

Primary Outcome Measures

Name	Time	Method
Time to report molecular profiling in tissue	28 days	To demonstrate the feasibility of real-time molecular profiling of metastatic breast cancer patients in less than 28 days from consent by evaluating the time to analysis and suggestions
Time to report molecular profiling in blood	28 days	2.1.2 To demonstrate the feasibility of real-time molecular profiling of blood samples in metastatic breast cancer patients within 4 weeks from consent to analysis

Secondary Outcome Measures

Name	Time	Method
Ability to make treatment suggestions	28 days	To demonstrate the ability to make treatment suggestions based on the molecular profile of patients' tumors
Decisions about Molecular Profiling Tumor Board (MPTB) suggestion	1 year	To analyze why clinicians/patients do or do not proceed with the suggestion of the MPTB
Progression-free survival	1 year	To describe progression-free survival (PFS) for women who act on the suggestion of the MPTB and for those choosing a different therapy from our suggestion
Changes in plasma tumor DNA (ptDNA)	1 year	To prospectively follow plasma tumor DNA in all patients who take part
Similarities and differences of the profiling results with the different assays in tissue	1 year	To examine the correlation of a smaller targeted gene panel between Foundation Medicine's assay and Johns Hopkins Molecular Diagnostics Lab assay

Trial Locations

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States