Breast Cancer Molecular Analysis Protocol (MAP-IT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01855503
Recruitment Status : Completed
First Posted : May 16, 2013
Last Update Posted : November 17, 2016
Foundation Medicine
Information provided by (Responsible Party):
Yale University

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.

Condition or disease Intervention/treatment
Metastatic Breast Cancer Procedure: Core Biopsy

Study Type : Observational
Actual Enrollment : 121 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Breast Cancer Molecular Analysis Prior to Investigational Therapy
Study Start Date : May 2013
Actual Primary Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
Metastatic Breast Cancer Procedure: Core Biopsy

Primary Outcome Measures :
  1. molecular analysis of metastatic breast cancer using DNA sequencing [ Time Frame: 2 years ]
    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 :
  1. To establish a metastatic breast cancer tissues resource for future research [ Time Frame: 2 years ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Metastatic Breast Cancer

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01855503

United States, Connecticut
Smilow Hospital Breast Center
New Haven, Connecticut, United States, 06520-8032
Sponsors and Collaborators
Yale University
Foundation Medicine
Principal Investigator: Lajos Pusztai, M.D., D.Phil Yale University

Responsible Party: Yale University Identifier: NCT01855503     History of Changes
Other Study ID Numbers: HIC# 1210010985
First Posted: May 16, 2013    Key Record Dates
Last Update Posted: November 17, 2016
Last Verified: November 2016

Keywords provided by Yale University:
Breast Cancer
Metastatic Breast Cancer

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