Breast Cancer 2-PREVENT Translational Center of Excellence (TCE) - Metastatic Markers of Recurrent Tumor Phenotype for Breast Cancer



Status:Recruiting
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/8/2016
Start Date:October 2013
Contact:Angela DeMichele, MD
Email:PennCancerTrials@emergingmed.com
Phone:855-216-0098

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This is a cohort study of women with suspected or confirmed recurrent breast cancer, with
accessible tumor by standard clinical biopsy, prior to starting a new therapy for recurrent
metastatic disease. Study participants will be ascertained from the population of all
persons greater than eighteen years of age receiving care at the clinical practices of the
Rowan Breast Center (RBC) at the University of Pennsylvania. The overarching goal of this
study is to identify the genetic and molecular markers of molecular evolution identified in
patients who have progressed from a primary diagnosis of breast cancer to recurrent,
metastatic disease. As an observational study, this study seeks to gather data regarding the
molecular and genetic changes that a primary cancer undergoes as a patient's cancer recurs
and ultimately progresses. We anticipate enrolling 50 women with recurrent breast cancer who
meet eligibility requirements for this study. Participation in this study will include the
following: a biopsy and blood collection, completion of the study questionnaire, an optional
bone marrow aspiration, and repeat collection of blood, offer of a research biopsy and a
optional bone marrow aspirate collection at each progression time point. The study
participants' medical information will be updated and changes in disease status will be
captured on a regular basis.


Inclusion Criteria:

- Histologically-confirmed breast cancer - based upon pathology report of the primary
or metastatic diagnosis

- Recurrent breast cancer (local, regional, or distant disease) - as determined by
either clinical,radiological, or pathological evaluation

- Willing to undergo or provide tissue from a recent biopsy of recurrent tumor for both
clinical and research testing

- Willing to undergo blood specimen collection

- Age 18 or over and are able to give informed consent

Exclusion Criteria:

- Non-metastatic breast cancer (stage I, II or III)

- Anticoagulation that cannot be interrupted for the purpose of study evaluation
(patients must have normal INR and PTT at the time of study biopsy)
We found this trial at
1
site
3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
(215) 662-6065
Principal Investigator: Angela DeMichele, MD
Phone: 855-216-0098
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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