Personalized Molecular Profiling for Breast Cancer

(IMAGE-II Trial)

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

200 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Personalized Molecular Profiling for Breast Cancer?

Molecular profiling in breast cancer has shown promise in identifying different subtypes of the disease, which can help tailor treatments to individual patients. This approach has led to the development of gene expression panels that predict how well a patient might respond to certain therapies, potentially improving treatment outcomes. ^{1 2 3 4 5}

Is Personalized Molecular Profiling for Breast Cancer safe for humans?

The research highlights that targeted therapies, which include personalized molecular profiling, are generally associated with less toxicity compared to traditional chemotherapy. However, the safety of these treatments can vary, and adverse effects should be considered in their application. ^{5 6 7 8 9}

How is the Personalized Molecular Profiling treatment for breast cancer different from other treatments?

Personalized Molecular Profiling for breast cancer is unique because it uses detailed genetic information to tailor treatment specifically to the individual's cancer type, unlike traditional treatments that are more generalized. This approach can identify specific molecular targets and predict how a patient will respond to certain therapies, potentially leading to more effective and personalized treatment plans. ^{1 2 10 11 12}

What is the purpose of this trial?

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.

Research Team

Vered Stearns, M.D.

Principal Investigator

Johns Hopkins University

Jenna Canzoniero, MD

Principal Investigator

SKCCC Johns Hopkins Medical Institution

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Molecular profiling in breast cancer. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Integrated breast cancer genomics. [2006]

3. United States pubmed.ncbi.nlm.nih.gov

Genomic, Transcriptomic, and Proteomic Profiling of Metastatic Breast Cancer. [2022]

4. England pubmed.ncbi.nlm.nih.gov

A new molecular breast cancer subclass defined from a large scale real-time quantitative RT-PCR study. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

A Review of Endocrine Therapy in Early-stage Breast Cancer: The Journey From Crudeness to Precision. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Cancer Evolution as the New Frontier of Precision Medicine. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Computational Screening of Anti-Cancer Drugs Identifies a New BRCA Independent Gene Expression Signature to Predict Breast Cancer Sensitivity to Cisplatin. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A comprehensive tool for tumor precision medicine with pharmaco-omics data analysis. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Innovative Strategies: Targeting Subtypes in Metastatic Breast Cancer. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Gene expression profiling of breast cancer. [2022]

11. Korea (South) pubmed.ncbi.nlm.nih.gov

Personalized medicine in breast cancer: a systematic review. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Molecular signatures in breast cancer. [2018]