Active — Not RecruitingNot Applicable

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

United States300 participantsStarted 2019-09-16

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this study is focused on collecting clinical information and biospecimens like tissue and fluid samples rather than testing a new treatment, what would actually happen to me day-to-day if I were to participate — and would it change my treatment plan at all?
2The trial is listed as 'active, not recruiting,' which means they're no longer enrolling new patients — is there any chance I could still be considered for participation, or are there similar biorepository studies currently open that I should know about?
3Given that this study is building a research collection for future use rather than measuring a treatment benefit right now, how might contributing my biospecimens help researchers studying metastatic or recurrent breast cancer down the line, and would I receive any results or findings from my samples?
4Since my diagnosis involves stage IV or recurrent breast cancer, should we be prioritizing an active treatment trial or a standard-of-care plan first, rather than a collection study like this one?
5If samples like peritoneal fluid or tumor tissue are collected as part of this study, are there any risks or discomforts associated with those collection procedures that I should weigh before deciding whether to participate?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Comprehensive biorepository creation

Timeframe: Up to 5 years

Trial details

NCT IDNCT03737695

SponsorMayo Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-09-15

View on ClinicalTrials.gov More Anatomic Stage IV Breast Cancer AJCC v8 trials