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

NCT02530008 | Active Not Recruiting DMC

• 1 other identifier: UPCC 30113
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Women With Suspected or Confirmed Recurrent Breast Cancer

Outcome Measures

Primary Outcomes (1)

• subjects with detectable DTCs/CTCs

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

women with recurrent breast cancer

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (2)

Lancaster General Hospital

Lancaster, Pennsylvania, 17602, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

• Angela DeMichele, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2015
• First Posted: August 20, 2015
• Study Start: October 1, 2013
• Primary Completion: October 1, 2024
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

US (2)