NCT01855503

Brief Summary

This is a molecular testing study for patients with metastatic breast cancer. The purpose of this study is to find defects in the DNA of the cancer that could potentially be treated with US Food and Drug Administration (FDA)approved or investigational drugs. For example, if your cancer has a mutation in the Epidermal Growth Factor Receptor (EGFR) gene (a mutation is a change int he DNA sequence of a gene) that makes this receptor "superactive" a drug that inhibits this receptor may also inhibit the growth of the cancer. If this genetic defect is not present in the cancer the same drug may not work. This EGFR gene mutation based patient selection for treatment has worked in lung cancer and we are testing its value in breast cancer. What drugs may be available against particular genetic abnormalities in the context of this clinical study will change over time.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
121

participants targeted

Target at P50-P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 16, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Last Updated

November 17, 2016

Status Verified

November 1, 2016

Enrollment Period

3.3 years

First QC Date

May 13, 2013

Last Update Submit

November 16, 2016

Conditions

Metastatic Breast Cancer

Keywords

MetastaticBreast CancerMetastatic Breast CancerBreastBiopsyMolecularGenetic

Outcome Measures

Primary Outcomes (1)

  • molecular analysis of metastatic breast cancer using DNA sequencing

    The primary goal is to survey the known DNA abnormalities with potential therapeutic relevance in cancer and steer patients to therapies that target the detected abnormalities.

    2 years

Secondary Outcomes (1)

  • To establish a metastatic breast cancer tissues resource for future research

    2 years

Study Arms (1)

Metastatic Breast Cancer

Procedure: Core Biopsy

Interventions

Core BiopsyPROCEDURE
Metastatic Breast Cancer

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Metastatic Breast Cancer

You may qualify if:

  • All patients with metastatic breast cancer who are considered for further systemic therapy are eligible regardless of number of prior therapies.
  • Patient must have a metastatic lesion that could be safely biopsied with or without image-guidance. The final arbiter to decide what lesion can be biopsied is the physician who will perform the biopsy.
  • There is no age limit for this study. However, this study will not include children because metastatic breast cancer does not occur in children.
  • Patients may participate in the biopsy study multiple times to repeat molecular assessment of the cancer after progression.
  • Patients who undergo routine clinical biopsy of metastatic breast cancer are also eligible to participate in this study. When the routine biopsies are obtained for diagnostic or other purposes, additional biopsies will be taken during the same biopsy session for molecular analysis.

You may not qualify if:

  • \. Known medical contraindication for needle biopsy procedure such as bleeding disorder, low platelet count, inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Smilow Hospital Breast Center

New Haven, Connecticut, 06520-8032, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biopsies of metastatic cancer

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm Metastasis

Interventions

Biopsy, Needle

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativePuncturesInvestigative Techniques

Study Officials

  • Lajos Pusztai, M.D., D.Phil

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2013

First Posted

May 16, 2013

Study Start

May 1, 2013

Primary Completion

August 1, 2016

Last Updated

November 17, 2016

Record last verified: 2016-11

Locations

US(1)