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Personalized Molecular Profiling in Cancer Treatment at Johns Hopkins (IMAGE-II)

Primary Purpose

Metastatic Breast Cancer

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Treatment recommendation

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring Metastatic Breast Cancer, Breast Cancer, Molecular profiling, Personalized medicine

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Allegheny Health Network Cancer Institute

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Genetic profiling

Arm Description

All participants will undergo genetic profiling. Archival tissue will be requested to undergo routine review for possible treatment recommendations. Blood samples will be obtained to study research correlates (plasma tumor DNA, ptDNA) and tissue comparison.

Outcomes

Primary Outcome Measures

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%.

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT02965755

First Posted

October 18, 2016

Last Updated

October 3, 2023

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

Foundation Medicine

1. Study Identification

Unique Protocol Identification Number

NCT02965755

Brief Title

Personalized Molecular Profiling in Cancer Treatment at Johns Hopkins

Acronym

IMAGE-II

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 26, 2018 (Actual)

Primary Completion Date

July 2024 (Anticipated)

Study Completion Date

July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

Foundation Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Breast Cancer

Keywords

Metastatic Breast Cancer, Breast Cancer, Molecular profiling, Personalized medicine

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Genetic profiling

Arm Type

Other

Arm Description

Intervention Type

Other

Intervention Name(s)

Treatment recommendation

Intervention Description

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.

Primary Outcome Measure Information:

Title

Ability of genetically profiling of ptDNA as assessed by identifying the proportion of genetic alterations in tumor tissue

Description

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%.

Time Frame

1 year

Title

Percentage of patients who cannot have NGS of metastatic site biopsy but have clinically actionable mutations detected via genetic profiling of ptDNA

Description

Percentage of patients for which genetic profiling of ptDNA would be more feasible when a metastatic biopsy cannot be acquired.

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Description

Change in number-of-folds decrease in allelic frequency of a given mutation in ptDNA 1 or 2 weeks after beginning new systemic therapy.

Time Frame

2 weeks

Title

Response as assessed by Change in Circulating tumor cell (CTC) counts

Description

Measure CTC counts at baseline, after 1-2 weeks of therapy, and at each restaging, up to 1 year.

Time Frame

Change from baseline up to 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vered Stearns, M.D.

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287-0013

Country

United States

Facility Name

Allegheny Health Network Cancer Institute

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15212

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Individual participant data will not be shared.

Learn more about this trial

Personalized Molecular Profiling in Cancer Treatment at Johns Hopkins

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