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300 patients help scientists unlock secrets of metastatic breast cancer

NCT ID NCT03737695

Knowledge-focused Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study collects blood and tissue samples from 300 people with breast cancer that has spread or come back. The goal is to create a large research registry that helps doctors understand why tumors spread and why people respond differently to treatments. Participants provide samples and medical information, but the study does not test a new treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2019

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with recurrent and/or metastatic breast cancer of all tumor subtypes

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm invasive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anatomic stage IV breast cancer ajcc V8 Invasive breast carcinoma Metastatic breast carcinoma Peritoneal effusion Recurrent breast carcinoma

Contacts and locations

Locations

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • FHCC South Lake Union

    Seattle, Washington, 98109, United States

  • Johns Hopkins University/Sidney Kimmel Cancer Center

    Baltimore, Maryland, 21287, United States

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007, United States

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, 10461, United States

  • UCSF Medical Center-Mission Bay

    San Francisco, California, 94158, United States

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599, United States

  • UPMC-Magee Womens Hospital

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233, United States

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637, United States

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104, United States

  • Vanderbilt Breast Center at One Hundred Oaks

    Nashville, Tennessee, 37204, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.