Personalized Molecular Profiling in Cancer Treatment at Johns Hopkins

N/AActive Not RecruitingNCT02965755

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Metastatic Breast Cancer

Interventions

Treatment recommendationOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (2)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Allegheny Health Network Cancer Institute

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

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%.

Time frame: 1 year

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.

Time frame: 1 year

Secondary Outcomes

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.

Time frame: 2 weeks

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.

Time frame: Change from baseline up to 1 year

Data from ClinicalTrials.gov

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