Breast Cancer Molecular Analysis Protocol (MAP-IT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Yale University
Sponsor:
Collaborator:
Foundation Medicine
Information provided by (Responsible Party):
Lajos Pusztai, Yale University
ClinicalTrials.gov Identifier:
NCT01855503
First received: May 13, 2013
Last updated: NA
Last verified: May 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Metastatic Breast Cancer
Procedure: Core Biopsy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Breast Cancer Molecular Analysis Prior to Investigational Therapy

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • molecular analysis of metastatic breast cancer using DNA sequencing [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • To establish a metastatic breast cancer tissues resource for future research [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The secondary objective is to establish a metastatic breast cancer tissues resource for future research to learn about biological events that drive metastatic cancer and to identify novel therapeutic targets and predictors of response to therapy.


Biospecimen Retention:   Samples With DNA

Biopsies of metastatic cancer


Estimated Enrollment: 200
Study Start Date: May 2013
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Metastatic Breast Cancer Procedure: Core Biopsy

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Metastatic Breast Cancer

Criteria

Inclusion Criteria:

  1. All patients with metastatic breast cancer who are considered for further systemic therapy are eligible regardless of number of prior therapies.
  2. 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.
  3. There is no age limit for this study. However, this study will not include children because metastatic breast cancer does not occur in children.
  4. Patients may participate in the biopsy study multiple times to repeat molecular assessment of the cancer after progression.
  5. 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.

Exclusion Criteria:

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01855503

Contacts
Contact: Noelle Sowers, RN 203-737-3472 noelle.sowers@yale.edu
Contact: Bonnie Lurie, RN 203 785 2836 bonnie.lurie@yale.edu

Locations
United States, Connecticut
Smilow Hospital Breast Center Recruiting
New Haven, Connecticut, United States, 06520-8032
Contact: Noelle Sowers, RN, BS, CCRC    203-737-3472    noelle.sowers@yale.edu   
Sponsors and Collaborators
Yale University
Foundation Medicine
Investigators
Principal Investigator: Lajos Pusztai, M.D., D.Phil Yale University
  More Information

No publications provided

Responsible Party: Lajos Pusztai, Professor of Medicine, Yale University
ClinicalTrials.gov Identifier: NCT01855503     History of Changes
Other Study ID Numbers: HIC# 1210010985
Study First Received: May 13, 2013
Last Updated: May 13, 2013
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Yale University:
Metastatic
Breast Cancer
Metastatic Breast Cancer
Breast
Biopsy
Molecular
Genetic

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 26, 2014