Breast Cancer Molecular Analysis Protocol (MAP-IT)
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Breast Cancer Molecular Analysis Prior to Investigational Therapy|
- 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.
- 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
|Study Start Date:||May 2013|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01855503
|Contact: Noelle Sowers, RNemail@example.com|
|Contact: Bonnie Lurie, RN||203 785 firstname.lastname@example.org|
|United States, Connecticut|
|Smilow Hospital Breast Center||Recruiting|
|New Haven, Connecticut, United States, 06520-8032|
|Contact: Noelle Sowers, RN, BS, CCRC 203-737-3472 email@example.com|
|Principal Investigator:||Lajos Pusztai, M.D., D.Phil||Yale University|