NCT Number: NCT02530008
Breast Cancer 2-PREVENT Translational Center of Excellence (TCE) - Metastatic Markers of Recurrent Tumor Phenotype for Breast Cancer
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 600 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.
This study is active but is not currently recruiting participants.
Notify MeKey information
Age range
18 year and older
Sex eligibility
Female
Study type
Observational
Primary location
Lancaster General Hospital, Lancaster, Pennsylvania, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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)
Treatment and study plan
Primary outcomes
-
subjects with detectable DTCs/CTCs
Time frame: 2 years
Sponsors and collaborators
Lead sponsor
Abramson Cancer Center at Penn Medicine
Other
Registry information
Important dates
- Study start
- 2013
- Primary completion
- 2024
- Study completion
- 2026
- First posted
- Aug 20, 2015
- Registry last updated
- Jan 22, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.