CLINICAL TRIAL / NCT03737695
Clinical Information and Biospecimen Collection From Patients With Recurrent or Stage IV Breast Cancer
- Observational
- Recruiting
- NCT03737695
Contact Information
AURORA US: Prospective Biospecimen Repository in Metastatic Breast Cancer
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.
PRIMARY OBJECTIVES:
I. 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:
I. 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.
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
No
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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