Breast Cancer Molecular Analysis Protocol (MAP-IT)

This study is currently recruiting participants.
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

May 13, 2013
May 13, 2013
May 2013
May 2015   (final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
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.
Same as current
Not Provided
Not Provided
 
Breast Cancer Molecular Analysis Protocol
Breast Cancer Molecular Analysis Prior to Investigational Therapy

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Biopsies of metastatic cancer

Probability Sample

Metastatic Breast Cancer

Metastatic Breast Cancer
Procedure: Core Biopsy
Metastatic Breast Cancer
Intervention: Procedure: Core Biopsy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Not Provided
May 2015   (final data collection date for primary outcome measure)

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

Both
Not Provided
No
Contact: Noelle Sowers, RN 203-737-3472 noelle.sowers@yale.edu
Contact: Bonnie Lurie, RN 203 785 2836 bonnie.lurie@yale.edu
United States
 
NCT01855503
HIC# 1210010985
No
Lajos Pusztai, Yale University
Yale University
Foundation Medicine
Principal Investigator: Lajos Pusztai, M.D., D.Phil Yale University
Yale University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP