Anatomic Stage IV Breast Cancer AJCC v8NCT03737695
Clinical Information and Biospecimen Collection From Patients With Recurrent or Stage IV Breast Cancer
An observational study of Anatomic Stage IV Breast Cancer AJCC v8 and Invasive Breast Carcinoma, run by Mayo Clinic at 14 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma, Metastatic Breast Carcinoma
- What is being tested?
- Biospecimen Collection and Medical Chart Review
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 14 sitesUnited States
- Study dates
- 16 Sep 2019to 15 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with recurrent and/or metastatic breast cancer of all tumor subtypes
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, 35233
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Duke University Medical Center
Durham, North Carolina, 27710
Vanderbilt Breast Center at One Hundred Oaks
Nashville, Tennessee, 37204
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
UPMC-Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
UCSF Medical Center-Mission Bay
San Francisco, California, 94158
FHCC South Lake Union
Seattle, Washington, 98109
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma, Metastatic Breast Carcinoma, Peritoneal Effusion, Recurrent Breast Carcinoma
- Being tested
- Biospecimen Collection, Medical Chart Review
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo biospecimen collection
Medical Chart ReviewOther
Also called Chart Review
Undergo clinical information collection
| Study group | Role | What they receive |
|---|---|---|
| Observational (biospecimen, clinical info collection) | 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. Receives: Procedure: Biospecimen Collection; Other: Medical Chart Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehensive biorepository creation
Will create a comprehensive biorepository that includes blood, archival tissue, fresh tissue, and linked molecular and clinical data from patients with recurrent and/or metastatic breast cancer.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start16 Sep 2019
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage IV Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karthik V. Giridhar, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03737695
- Sponsor's protocol ID
- AURORA US
- Other IDs
- NCI-2018-02144, AURORA, 18-001910
- Status last verified
- Jun 2026
- First submitted
- 8 Nov 2018
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AURORA US: Prospective Biospecimen Repository in Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT03737695
- Acronym / sponsor ID
- AURORA US
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma, Metastatic Breast Carcinoma, Peritoneal Effusion, Recurrent Breast Carcinoma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 9 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (biospecimen, clinical info collection) | – | Procedure: Biospecimen Collection, Other: Medical Chart ReviewPatients' 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with recurrent and/or metastatic breast cancer of all tumor subtypes
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo biospecimen collection | Procedure or surgery | Observational (biospecimen, clinical info collection) |
| Medical Chart ReviewAlso: Chart ReviewUndergo clinical information collection | Other | Observational (biospecimen, clinical info collection) |
Primary outcome
Comprehensive biorepository creation
Time frame: Up to 5 years
Will create a comprehensive biorepository that includes blood, archival tissue, fresh tissue, and linked molecular and clinical data from patients with recurrent and/or metastatic breast cancer.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karthik V. Giridhar, M.D. principal investigator
Mayo Clinic
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anatomic Stage IV Breast Cancer AJCC v8 and Invasive Breast Carcinoma, run by Mayo Clinic at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehensive biorepository creation (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.