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Genetic Testing

Personalized Molecular Profiling for Breast Cancer (IMAGE-II Trial)

N/A

Waitlist Available

Led By Vered Stearns, M.D.

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Diagnosed with metastatic breast cancer and received prior chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

IMAGE-II Trial Summary

This trial is testing whether genetic information from a person's blood sample can be used to make treatment suggestions, in the same way it is done with tumor tissue samples.

Who is the study for?

This trial is for adults over 18 with metastatic breast cancer who've had a tumor biopsy in the last 3 years and have available tissue. It's open to all clinical phenotypes of breast cancer, including Triple negative, Hormone receptor positive, and HER2-positive patients who've previously undergone chemotherapy. Pregnant or nursing women are excluded.Check my eligibility

What is being tested?

The study aims to see if genetic information from blood samples can match that from tumor tissues and whether this data can guide treatment recommendations for individuals with metastatic breast cancer.See study design

What are the potential side effects?

Since the intervention involves only treatment recommendations based on genetic profiling rather than direct medical treatments, there are no direct side effects associated with this trial.

IMAGE-II Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer is either triple negative, hormone receptor positive, or HER2 positive.

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I have metastatic breast cancer and have had chemotherapy before.

IMAGE-II Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Secondary outcome measures

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

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.

IMAGE-II Trial Design

1Treatment groups

Experimental Treatment

Group I: Genetic profilingExperimental Treatment1 Intervention

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.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor

557 Previous Clinical Trials

32,700 Total Patients Enrolled

44 Trials studying Breast Cancer

4,978 Patients Enrolled for Breast Cancer

Foundation MedicineIndustry Sponsor

32 Previous Clinical Trials

15,992 Total Patients Enrolled

1 Trials studying Breast Cancer

197 Patients Enrolled for Breast Cancer

Vered Stearns, M.D.Principal InvestigatorJohns Hopkins University

4 Previous Clinical Trials

164 Total Patients Enrolled

1 Trials studying Breast Cancer

6 Patients Enrolled for Breast Cancer

Media Library

Personalized Molecular Profiling (Genetic Testing) Clinical Trial Eligibility Overview. Trial Name: NCT02965755 — N/A

Breast Cancer Research Study Groups: Genetic profiling

Breast Cancer Clinical Trial 2023: Personalized Molecular Profiling Highlights & Side Effects. Trial Name: NCT02965755 — N/A

Personalized Molecular Profiling (Genetic Testing) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02965755 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do those aged eighty-five or older qualify for participation in this investigation?

"This trial is limited to those aged 18-100, but there are separate clinical trials available for minors and seniors. Specifically, 64 studies seek participation from individuals below the age of consent while 2,217 investigations target patients above 65 years old."

Answered by AI

Is recruitment of participants still in progress for this clinical trial?

"The trial's presence on clinicaltrials.gov indicates that it is actively seeking to sign up participants. It was first made available for enrollment in January 2018, and the latest update was posted in August 2022."

Answered by AI

Am I eligible to join this experiment?

"This clinical trial seeks to recruit 200 individuals aged 18 or above and below 100, with a history of breast cancer. Other prerequisites include having received a metastatic tumor biopsy within 3 years prior to the date of first blood sample for this study; being Male/Female; any phenotype (Triple negative, Hormone receptor positive, human epidermal growth factor receptor 2 (HER2)-positive), as well as providing informed consent."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Personalized Molecular Profiling in Cancer Treatment at Johns Hopkins

2018. "Personalized Molecular Profiling in Cancer Treatment at Johns Hopkins". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02965755.

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