Personalized Molecular Profiling for Breast Cancer

(IMAGE-II Trial)

Not currently recruiting at 2 trial locations

Overseen By Kimmel Cancer Center Clinical Research Office

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Disqualifiers: Pregnancy, Nursing

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if genetic information from a simple blood test can match insights from a tumor biopsy and assist in guiding breast cancer treatment. It focuses on individuals with metastatic breast cancer who have previously undergone chemotherapy. Participants should have had a tumor biopsy in the last three years, with tissue still available for study. This trial may suit those with any type of breast cancer who can provide informed consent. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could enhance future breast cancer treatments.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this personalized molecular profiling is safe for genetic information collection?

Research has shown that personalized treatment plans in cancer care enhance treatment effectiveness and reduce side effects. This approach involves analyzing a patient's genes to develop a treatment plan tailored to their unique genetic profile. Studies have found that this method helps doctors identify specific changes in a tumor's genes, guiding treatment choices. By targeting these changes, doctors often achieve better results with fewer side effects. These findings suggest that personalized treatment plans are generally safe and well-tolerated, as they aim to minimize unwanted side effects by customizing treatment for each individual. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Personalized Molecular Profiling for breast cancer because it offers a tailored approach to treatment. Unlike standard treatments like surgery, chemotherapy, or radiation, which are often applied broadly, this method uses genetic profiling to understand the unique characteristics of an individual's cancer. By analyzing both archival tissue and blood samples, this approach aims to identify personalized treatment recommendations that target specific genetic mutations. This could lead to more effective and less toxic treatments, offering hope for better outcomes and improved quality of life for patients.

What evidence suggests that personalized molecular profiling is effective for breast cancer?

Studies have shown that personalized molecular profiling can tailor breast cancer treatments by examining genetic information. In this trial, all participants will undergo genetic profiling to guide treatment decisions. Research indicates that this approach makes care more effective and can reduce side effects. One study analyzed the DNA of 103 breast cancer patients and identified specific genes linked to cancer. This enables doctors to select the best treatments based on the unique genetic makeup of a person's cancer. Personalized approaches like these are transforming cancer care and improving patient outcomes. ^{1 3 6 7 8}

Who Is on the Research Team?

Vered Stearns, M.D.

Principal Investigator

Johns Hopkins University

Jenna Canzoniero, MD

Principal Investigator

SKCCC Johns Hopkins Medical Institution

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Able to voluntarily provide informed consent

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

I have metastatic breast cancer and have had chemotherapy before.

Exclusion Criteria

I am not pregnant or nursing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Genetic Profiling

Participants undergo genetic profiling using blood samples to obtain personalized genetic information for treatment suggestions

1 year

Treatment

Participants receive treatment based on genetic profiling results, with response assessed by changes in ptDNA and CTC counts

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment, with changes in ptDNA and CTC counts measured

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Personalized Molecular Profiling

Trial Overview 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.

How Is the Trial Designed?

Group I: Genetic profiling Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

Avon Foundation

Collaborator

Trials

16

Recruited

1,100+

Biocept, Inc.

Industry Sponsor

Trials

4

Recruited

5,500+

Foundation Medicine

Industry Sponsor

Trials

37

Recruited

17,600+

Published Research Related to This Trial

The study introduces DBPOM, a comprehensive web server that integrates drug efficacy and toxicity data for over 10,000 small molecule compounds, aiding in cancer precision medicine by allowing clinicians to analyze both the positive and negative effects of drugs on patients.

By bridging the gap between cell culture and living tissue, the platform helps predict the effectiveness of FDA-recommended drugs based on individual genetic characteristics, making it a valuable resource for personalized cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comprehensive tool for tumor precision medicine with pharmaco-omics data analysis. Liu, Y., Song, F., Li, Z., et al.[2023]

Targeted therapies, particularly CDK 4/6 inhibitors, have shown significant improvements in progression-free survival (PFS) for patients with estrogen receptor (ER) and/or HER2+ metastatic breast cancer compared to traditional endocrine therapy.

PARP inhibitors have been FDA-approved for BRCA-associated cancers, demonstrating longer PFS than standard chemotherapy, and newer antibody drug conjugates provide a targeted method to deliver potent treatments directly to metastatic sites with reduced toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovative Strategies: Targeting Subtypes in Metastatic Breast Cancer. Pegram, MD., Zong, Y., Yam, C., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12346032/

Real-World Data from a Molecular Tumor Board - PMC In this study, we performed genetic profiling in 103 breast cancer patients using an NGS assay covering 324 cancer-relevant genes. The results ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0305737225000313

First versus second-generation molecular profiling tests Both Oncotype DX and Prosigna have been demonstrated to be effective prognostic tools in early breast cancer, with Oncotype DX also being validated as a ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11711544/

Advancing precision and personalized breast cancer ... This article describes recent advances in molecular subtyping and multi-omics technologies that are driving key innovations to optimise patient outcomes.

4. targetedonc.com targetedonc.com/view/evolution-of-personalized-cancer-care-with-molecular-profiling

Evolution of Personalized Cancer Care With Molecular ... Molecular oncology is revolutionizing cancer care by using genetic profiling to tailor personalized treatments, improving efficacy, minimizing adverse events.

5. nature.com nature.com/articles/s41698-025-00858-0

A nationwide comprehensive genomic profiling and ... CGP success rates in the different tumor types ranged from 72% to 100% (Supplementary Fig. S2). The lowest success rates are observed for uveal ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2950212825000119

Preventive, personalized, and precision medicine ... Molecular profiling helps guide tumor features and treatment decisions by identifying molecular changes, including mutations, gene expression patterns [30], and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4535810/

Advances in Breast Cancer: Pathways to Personalized Medicine MicroRNA profiling has revealed that they are frequently deregulated in human tumors. MicroRNAs have been show to affect oncogenes, tumor suppressor genes, and ...

8. link.springer.com link.springer.com/article/10.1007/s12609-024-00568-9

Genomic Molecular Profiling in Breast Cancer Prognostic genomic signatures are used to assess the overall outcome of a cancer patient, independent of the specific treatment they receive.