Metastatic Breast Cancer
Conditions
Keywords
Metastatic Breast Cancer, Breast Cancer, Molecular profiling, Personalized medicine
Brief summary
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.
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.
Interventions
OTHERTreatment recommendation
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.
Sponsors
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Foundation Medicine
Avon Foundation
Biocept, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ability of genetically profiling of ptDNA as assessed by identifying the proportion of genetic alterations in tumor tissue | 1 year | 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 | 1 year | Percentage of patients for which genetic profiling of ptDNA would be more feasible when a metastatic biopsy cannot be acquired. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 2 weeks | 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 | Change from baseline up to 1 year | Measure CTC counts at baseline, after 1-2 weeks of therapy, and at each restaging, up to 1 year. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORVered Stearns, M.D.
Johns Hopkins University
PRINCIPAL_INVESTIGATORJenna Canzoniero, MD
SKCCC Johns Hopkins Medical Institution
Outcome results
None listed