Personalized Molecular Profiling in Cancer Treatment at Johns Hopkins

Metastatic Breast Cancer Clinical Trial

— IMAGE-II  

Official title:

Individualized Molecular Analyses Guide Efforts in Breast Cancer - Personalized Molecular Profiling in Cancer Treatment at Johns Hopkins

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02965755
• Other study ID #: J16146
• Secondary ID: IRB00117742
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 26, 2018
• Est. completion date: July 2024

Study information

• Verified date: October 2023
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this research study is to determine if we can obtain personalized genetic information from a subject's blood sample that is similar to that obtained from a tumor tissue sample, and if we can use that information to make treatment suggestions.

Description:

The goal of this research study is to determine if we can obtain personalized genetic information from a subject's blood sample that is similar to that obtained from a tumor tissue sample, and if we can use that information to make treatment suggestions. As tumor samples can be difficult to collect, we hope to be able to collect similar genetic information from blood or urine samples that we find in tumor tissue. Ultimately, we hope to identify genes important to cancer cells that could potentially identify standard-of-care or research-based recommendations for therapy.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Male or Female

• 18 years of age or older

• Metastatic breast cancer and treatment with prior chemotherapy

• Any clinical phenotype (Triple negative, Hormone receptor positive, human epidermal growth factor receptor 2 (HER2)-positive)

• Patient must have received a metastatic tumor biopsy within 3 years prior to the date of the first planned blood sample for the study and have tissue available from this biopsy

• Able to voluntarily provide informed consent

Exclusion Criteria:

• Women who are pregnant or nursing

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Other:
• Treatment recommendation
Depending on the results from the participant's archival tissue, a panel of Johns Hopkins investigators will meet to interpret the molecular and genetic profiling results in order to identify any actionable mutations to provide a personalized treatment recommendation for the patient.

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Allegheny Health Network Cancer Institute	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Foundation Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability of genetically profiling of ptDNA as assessed by identifying the proportion of genetic alterations in tumor tissue	The proportion of genetic alterations in tumor tissue is detected via genetic profiling of ptDNA when those genetic alterations are present in the tumor at an allelic frequency >10%.	1 year
Primary	Percentage of patients who cannot have NGS of metastatic site biopsy but have clinically actionable mutations detected via genetic profiling of ptDNA	Percentage of patients for which genetic profiling of ptDNA would be more feasible when a metastatic biopsy cannot be acquired.	1 year
Secondary	Response as assessed by change in ptDNA level up to 2 weeks post-intervention. To determine whether a 10-fold decrease in allelic frequency of a given mutation in ptDNA after initiating new systemic therapy can predict for response to treatment.	Change in number-of-folds decrease in allelic frequency of a given mutation in ptDNA 1 or 2 weeks after beginning new systemic therapy.	2 weeks
Secondary	Response as assessed by Change in Circulating tumor cell (CTC) counts	Measure CTC counts at baseline, after 1-2 weeks of therapy, and at each restaging, up to 1 year.	Change from baseline up to 1 year