Disseminated Tumor Cells in Blood and Bone Marrow Samples from Patients Previously Treated for Breast Cancer

Status: Active

Description

This trial studies disseminated tumor cells in blood and bone marrow samples from patients previously treated for breast cancer. Studying samples of blood and bone marrow from patients with breast cancer in the laboratory may help doctors to determine whether there are any dormant tumor cells in the body. It may also help doctors to better understand what disseminated tumor cells are and how they can be best treated to improve the treatment and prevention of breast cancer in the future.

Eligibility Criteria

Inclusion Criteria

  • Histologically-confirmed primary invasive breast cancer within 5 years of study entry
  • Pathologically-confirmed invasive breast cancer in axillary lymph nodes or tumor with triple negative subtype: negative estrogen receptor (ER), progesterone receptor (PR) and Her2-overexpression by American Society of Clinical Oncology-College of American Pathologists (ASCO-CAP) guidelines or tumor with a breast cancer recurrence score of >= 18 per the Genomic Health Oncotype DX breast cancer test, or residual disease after neoadjuvant chemotherapy
  • Completed all primary therapy (surgery, [neo]adjuvant chemotherapy and adjuvant radiation) for the index malignancy with
  • No evidence of local or distant recurrent disease by physical examination, blood tests (complete blood count [CBC], liver function tests [LFTs], alkaline phosphatase [alk phos]), or symptom-directed imaging, per National Comprehensive Cancer Network (NCCN) guidelines
  • Prothrombin time (PT) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) per institutional laboratory range; for patients on therapeutic anti-coagulants, medication must be clinically held peri-procedure per standard clinical management
  • Willing to undergo bone marrow aspiration and blood specimen collection per protocol specifications
  • Able to give informed consent
  • Patient has no evidence of meeting exclusion criteria for companion clinical trials

Exclusion Criteria

  • Concurrent enrollment on another investigational therapy
  • Patients receiving chronic, high dose systemic treatment with corticosteroids defined as: chronic use of cortisone > 50 mg; hydrocortisone > 40 mg, prednisone > 10 mg, methylprednisone > 8 mg or dexamethasone > 1.5 mg; or another immunosuppressive agent; topical or inhaled corticosteroids are allowed
  • Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: * Symptomatic congestive heart failure of New York heart Association class III or IV * Unstable angina pectoris, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease * Severely impaired lung function with a previously documented spirometry and diffusing capacity of the lungs for carbon monoxide (DLCO) that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air * Uncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULN * Active (acute or chronic) or uncontrolled severe infections * Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis * A known history of human immunodeficiency virus (HIV) seropositivity as reported by the patient * Impairment of gastrointestinal function or gastrointestinal disease (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection) * Patients with an active, bleeding diathesis
  • Female patients who are pregnant or breast feeding; women of childbearing potential must have a negative urine or serum pregnancy test
  • Patients who have received prior treatment with an mechanistic target of rapamycin (mTOR) inhibitor (sirolimus, temsirolimus, everolimus)
  • Patients with a known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to its excipients
  • A detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients; hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and hepatitis C virus (HCV) RNA polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection

Locations & Contacts

Pennsylvania

Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: Active
Contact: Angela M. DeMichele
Phone: 215-615-6820
Email: PennCancerTrials@emergingmed.com

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine the incidence and frequency of bone marrow in patients who have completed primary treatment for breast cancer for eligibility to a recurrence prevention trial.

SECONDARY OBJECTIVES:

I. To compare the frequency and concordance between an immunohistochemical assay (disseminated tumor cells [DTC]-immunohistochemistry [IHC]) and flow cytometric-based assay (DTC-Flow) to detect DTCs in patients who have completed primary treatment for breast cancer and are undergoing surveillance.

II. To compare the molecular and genetic features between primary tumor and disseminated tumor cells (DTCs) among those patients who harbor DTCs.

OUTLINE:

Patients undergo blood collection and bone marrow aspiration for DTCs assessment via DTC-IHC, DTC-Flow, whole exome sequencing, and ribonucleic acid sequencing (RNA-seq).

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Screening

Lead Organization

Lead Organization
University of Pennsylvania / Abramson Cancer Center

Principal Investigator
Angela M. DeMichele

Trial IDs

Primary ID UPCC 28115
Secondary IDs NCI-2016-00609
Clinicaltrials.gov ID NCT02732171