Clinical Information and Biospecimen Collection From Patients With Recurrent or Stage IV Breast C… (NCT03737695) | Clinical Trial Compass
SuspendedNot Applicable
Clinical Information and Biospecimen Collection From Patients With Recurrent or Stage IV Breast Cancer
Stopped: enrollment pause
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 range18 Years
SexALL
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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 …