Disseminated Tumor Cells and Circulating Tumor Cells as Markers of Recurrent and Metastatic Disease in Patients With Breast Cancer

This trial studies disseminated tumor cells (DTCs) and circulating tumor cells (CTCs) as markers of recurrent metastatic disease in patients with breast cancer. Studying samples of blood, bone marrow, and tissue from patients with breast cancer in the laboratory may help doctors understand the molecular and genetic changes that a primary tumor undergoes as the tumor comes back and spreads to another place in the body.

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
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 international normalized ratio [INR] and partial thromboplastin time [PTT] at the time of study biopsy)

Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02530008.

PRIMARY OBJECTIVES:

I. 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.

OUTLINE: This is an observational study.

Samples of blood, bone marrow, and tissue are collected for the analysis of DTCs and CTCs.

Trial PhaseNo phase specified

Trial TypeNot provided by clinicaltrials.gov

Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center

Principal InvestigatorAngela M. DeMichele

Primary IDUPCC 30113
Secondary IDsNCI-2014-00624
ClinicalTrials.gov IDNCT02530008

Disseminated Tumor Cells and Circulating Tumor Cells as Markers of Recurrent and Metastatic Disease in Patients With Breast Cancer

Inclusion Criteria

Exclusion Criteria

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Disseminated Tumor Cells and Circulating Tumor Cells as Markers of Recurrent and Metastatic Disease in Patients With Breast Cancer

Description

Eligibility Criteria

Locations & Contacts

Trial Objectives and Outline

Trial Phase & Type

Lead Organization

Trial IDs

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