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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02530008

Enrollment

600

Registered

2015-08-20

Start date

2013-10-01

Completion date

2026-10-01

Last updated

2026-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Women With Suspected or Confirmed Recurrent Breast Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
subjects with detectable DTCs/CTCs	2 years

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAngela DeMichele, MD

Abramson Cancer Center at Penn Medicine

Outcome results