Clinical trial NCT02965755: Personalized Molecular Profiling in Cancer Treatment at Johns Hopkins
Official title: Individualized Molecular Analyses Guide Efforts in Breast Cancer - Personalized Molecular Profiling in Cancer Treatment at Johns Hopkins
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Metastatic Breast Cancer
Keywords: Metastatic Breast Cancer
Breast Cancer
Molecular profiling
Personalized medicine
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Foundation Medicine
name: Avon Foundation
name: Biocept, Inc.
First posted: 2016-11-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ability of genetically profiling of ptDNA as assessed by identifying the proportion of genetic alterations in tumor tissue
timeFrame: 1 year
measure: Percentage of patients who cannot have NGS of metastatic site biopsy but have clinically actionable mutations detected via genetic profiling of ptDNA
timeFrame: 1 year
Secondary outcomes:
measure: 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.
timeFrame: 2 weeks
measure: Response as assessed by Change in Circulating tumor cell (CTC) counts
timeFrame: Change from baseline up to 1 year
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Pittsburgh
country: United States
facility: Allegheny Health Network Cancer Institute
state: Pennsylvania
Study officials:
affiliation: Johns Hopkins University
name: Vered Stearns, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: SKCCC Johns Hopkins Medical Institution
name: Jenna Canzoniero, MD
role: PRINCIPAL_INVESTIGATOR
References: