Clinical Information and Biospecimen Collection From Patients With Recurrent or Stage IV Breast Cancer

a study on Breast Cancer Peritoneal Effusion Carcinoma

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Hope Rugo
Headshot of Hope Rugo
Hope Rugo

Description

Summary

This trial collects clinical information and tissue and blood samples from patients with breast cancer that has come back or is stage IV. Collecting clinical information and biospecimen samples to create a registry may help doctors better understand the mechanism of tumor spread and determine why people respond differently to specific cancer treatments.

Official Title

AURORA US: Prospective Biospecimen Repository in Metastatic Breast Cancer

Details

PRIMARY OBJECTIVES:

  1. To create a comprehensive registry that includes patient demographics, clinical and histopathological data, blood samples, and tissue specimens from the primary tumor and metastatic sites of patients with metastatic breast cancer to improve our understanding of the mechanisms of tumor metastasis and therapeutic resistance.

II. To conduct genomic studies of paired primary tumors and distant metastatic sites.

III. To conduct genomic studies of paired distant metastatic sites obtained during the course of an individual's disease.

IV. To conduct genomic studies of cell free deoxyribonucleic acid (DNA), circulating tumor cell (CTC) derived DNA, germline DNA, and immune based markers in the peripheral circulation.

SECONDARY OBJECTIVE:

  1. To evaluate the concordance between DNA sequencing results obtained from a clinically available assay and those obtained specifically for research purposes.

OUTLINE:

Patients' archival and newly collected tissue and blood samples are collected periodically for genetic testing. Patients also undergo collection of clinical information within 30 days of biopsy procedure and every 4 months.

Keywords

Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma, Metastatic Breast Carcinoma, Peritoneal Effusion, Recurrent Breast Carcinoma, Carcinoma, Breast Neoplasms, Biospecimen Collection, Medical Chart Review

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histologically confirmed or suspected invasive breast cancer
  • Radiographic evidence of distant metastatic disease
  • Clinical or radiographic evidence of disease progression OR presenting with de novo stage IV disease
  • Available archived tissue from the initial breast primary (formalin fixed paraffin embedded [FFPE] tissue is acceptable; fresh frozen tissue is preferred if available)
  • Accessible lesion representative of recurrent or metastatic breast cancer for biopsy
    • Type 1 specimen collection: Patients undergoing a clinically directed tissue biopsy or tissue collection who are willing to have additional specimens taken for research during the same procedure. Sites for tissue acquisition may include the breast, skin/chest wall, lymph node/soft tissue, liver, bone, lung, brain, pleural fluid, and ascites as needed for routine clinical care
    • Type 2 specimen collection: Patients undergoing a tissue biopsy or tissue collection for research purposes only. Sites for tissue acquisition include the breast, skin/chest wall, lymph node/soft tissue, liver, bone, pleural fluid, and ascites. Research directed lung biopsies and brain biopsies are not permitted. Procedures for tissue acquisition are restricted to those performed under local anesthesia or intravenous (IV) conscious sedation; biopsies that require general anesthesia are not permitted in this situation
  • Previous cytologic confirmation of malignant pleural effusion or ascites if that is the planned source of fresh specimen collection for study participation
  • Age 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Ability to understand and the willingness to sign an informed consent document

You CAN'T join if...

  • Concurrent disease or condition that in the opinion of the treating oncologist or the provider performing the biopsy procedure renders the patient inappropriate for study participation
  • Concurrent serious medical or psychiatric disorder that may interfere with the subject's safety during the biopsy or tissue collection procedure
  • Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent
  • History of a serious or life-threatening allergic reaction to local anesthetics (e.g., lidocaine, xylocaine) used during a biopsy procedure
  • Pregnancy (due to the risk of conscious sedation or anesthesia to mother and fetus)
  • Any condition or laboratory finding that in the opinion of the treating oncologist or the provider performing the biopsy procedure would make participation in this protocol hazardous for the patient

Locations

  • UCSF Medical Center-Mission Bay accepting new patients
    San Francisco California 94158 United States
  • FHCC South Lake Union accepting new patients
    Seattle Washington 98109 United States

Lead Scientist at UCSF

  • Hope Rugo
    Dr. Hope Rugo is a medical oncologist and hematologist specializing in breast cancer research and treatment. A Clinical Professor of Medicine, Dr. Rugo joined the Breast Care Center in 1999 after a decade of experience at UCSF in malignant hematology and bone marrow transplantation for a variety of diseases, including breast cancer.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Mayo Clinic
ID
NCT03737695
Study Type
Observational
Participants
Expecting 300 study participants
Last Updated
Contact us about this trial