Examining how molecular markers relate to breast cancer treatment responses

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect and analyze tumor tissue and blood samples from women diagnosed with locally advanced or metastatic breast cancer. By cataloging these biological specimens and associated clinical data, researchers hope to identify biomarkers that can predict treatment responses and improve understanding of cancer behavior. The study involves core biopsies and blood sampling at various stages of treatment, with a focus on fostering collaboration between laboratory and clinical scientists for innovative research. A total of 500 patients will be enrolled across multiple centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

High suspicion of or known breast cancer (early or metastatic)

Lesion accessible for safe biopsy (as deemed by the treating physician).

Age ≥ 18 years.

ECOG performance status 0 - 2.

Ability to understand and willingness to sign an informed consent document.

If receiving therapeutic anticoagulation; it should be discontinued temporarily prior to biopsy for a length of time to be determined by the study doctor.

Adequate marrow function, defined as absolute neutrophil count ≥ 1.5 x 109/L and platelets ≥ 100 x 109/L required only for biopsies of vital organs (lung, liver, etc.)

Exclusion Criteria:

Concurrent disease or condition that would make the patient inappropriate for study participation or any serious medical or psychiatric disorder that would interfere with the subject's safety.

Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.

History of serious or life-threatening allergic reaction to local anesthetics (i.e. lidocaine, xylocaine)

Pregnant women are excluded because there may be an increased risk to both mother and fetus in the setting of conscious sedation, which is required for biopsies of certain anatomic sites (e.g. liver, lung). Also, ionizing radiation from CT-guided biopsies may pose a risk to the unborn fetus.

Cardiac disease making it unsafe to biopsy in the opinion of the treating physician.

If patients receiving bevacizumab or other angiogenesis inhibitors are less than 6 weeks from last dose of the angiogenesis inhibitor, they should not undergo research core biopsies of vital organs (lung, liver, etc.) on this protocol because of the concern for the possibility of increased bleeding risk and delayed healing. Patients receiving bevacizumab or other angiogenesis inhibitors who are undergoing a research biopsy of the breast, peripheral lymph node or a skin punch biopsy must be two weeks from the last dose of the angiogenesis inhibitor.

Where it's running

• Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
  Chapel Hill, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Lisa A. Carey, MD — UNC Lineberger Comprehensive Cancer Center
• Study coordinator: Adrianna Warner
• Email: adrianna_warner@med.unc.edu
• Phone: (919) 966-7847

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.