NCT01939847

Brief Summary

This study will test the feasibility of identifying patients who could benefit from tumor molecular profiling, of analyzing the patients' tumors in a timely (28 day) fashion, and of the identification of possible actionable mutations that are not just biologically interesting but are clinically relevant. The investigators will also examine the outcome data from patients who followed the Molecular Profiling Tumor Board suggestion compared with those who did not. When the tissue studies are done, an additional group of patients will be enrolled to test if the same is possible in blood samples.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 11, 2013

Completed
8 days until next milestone

Study Start

First participant enrolled

September 19, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2015

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

February 28, 2019

Status Verified

February 1, 2019

Enrollment Period

1.6 years

First QC Date

September 3, 2013

Last Update Submit

February 27, 2019

Conditions

Metastatic Breast Cancer

Keywords

Metastatic breast cancerBreast cancerMolecular profilingPersonalized medicine

Outcome Measures

Primary Outcomes (2)

  • Time to report molecular profiling in tissue

    To demonstrate the feasibility of real-time molecular profiling of metastatic breast cancer patients in less than 28 days from consent by evaluating the time to analysis and suggestions

    28 days

  • Time to report molecular profiling in blood

    2.1.2 To demonstrate the feasibility of real-time molecular profiling of blood samples in metastatic breast cancer patients within 4 weeks from consent to analysis

    28 days

Secondary Outcomes (5)

  • Ability to make treatment suggestions

    28 days

  • Decisions about Molecular Profiling Tumor Board (MPTB) suggestion

    1 year

  • Progression-free survival

    1 year

  • Changes in plasma tumor DNA (ptDNA)

    1 year

  • Similarities and differences of the profiling results with the different assays in tissue

    1 year

Other Outcomes (1)

  • Similarities and differences of the profiling assay results between blood and tissue samples

    1 year

Study Arms (2)

Molecular prolfiling in tissue

EXPERIMENTAL

Participant's tumor will be analyzed by Foundation Medicine on their FoundationOne platform - a targeted whole exome sequencing of 182 cancer related genes (3,230 exons) as well as 37 introns from 14 genes commonly rearranged or altered in cancer via next-generation sequencing technology to provide a molecular profile for a possible treatment suggestion

Other: Treatment suggestion

Molecular prolfiling in blood

NO INTERVENTION

Participant's blood sample will be analyzed by Foundation Medicine on their FoundationOne platform - a targeted whole exome sequencing of 182 cancer related genes (3,230 exons) as well as 37 introns from 14 genes commonly rearranged or altered in cancer via next-generation sequencing technology; however, this is just being done to see if it is possible to generate similar results in blood samples. We do not yet know if blood sample results may be used for treatment decision (this will be tested in a future study) and results will not be given to participants; therefore, no treatment suggestion will be given.

Interventions

Treatment suggestionOTHER

Based on any actionable findings of the molecular profiling results, the investigators will come up with a suggestion for approved treatment or for clinical trial by referencing institutional clinical trials or potentially nationwide possibilities (www.clinicaltrials.gov).

Molecular prolfiling in tissue

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female
  • years of age or older
  • Metastatic breast cancer and treatment with prior chemotherapy (either in adjuvant, neoadjuvant or metastatic setting)
  • Triple negative clinical phenotype (ER-, PR-, HER2-). For HER2 assessment, a negative result is an immunohistochemical (IHC staining of 0 or 1+, a FISH result of less than 4.0 HER2 gene copies per nucleus, or a FISH ratio of less than 1.8. ER/PR will be assessed by IHC and will be defined as positive/negative using the American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) Guidelines. Estrogen receptor (ER) and progesterone receptor (PR) assays will be considered positive if there are at least 1% positive tumor nuclei in the sample on testing in the presence of expected reactivity of internal (normal epithelial elements) and external controls. NOTE: A triple negative clinical phenotype based upon the patient's clinical course may also be eligible as determined at the discretion of the Study Chair (ie, if a patient is behaving clinically as ER/PR negative but does not meet the strict criteria outlined.)
  • Patients must have a tumor suitable for biopsy and be deemed medically appropriate to undergo a biopsy
  • Able to voluntarily provide informed consent

You may not qualify if:

  • N/A
  • MOLECULAR PROFILING IN BLOOD:
  • Male or Female
  • years of age or older
  • Metastatic breast cancer
  • Any phenotype of breast cancer is eligible for enrollment (i.e., any ER, PR, and HER2 status).
  • Able to voluntarily provide informed consent
  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Vered Stearns, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2013

First Posted

September 11, 2013

Study Start

September 19, 2013

Primary Completion

May 14, 2015

Study Completion

February 1, 2017

Last Updated

February 28, 2019

Record last verified: 2019-02

Locations

US(1)