Correlation of Molecular Markers With Response to Therapy and Breast Cancer Behavior
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Blood draws
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "PURPOSE: This research study is looking at tissue and blood samples from women with locally advanced or metastatic breast cancer"
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at tumor tissue and blood to find DNA changes and other signs linked to breast cancer and how it responds to treatment. It focuses on women with breast cancer that has spread nearby or to other parts of the body, but the entry rules also allow known or strongly suspected early breast cancer.
RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment. PURPOSE: This research study is looking at tissue and blood samples from women with locally advanced or metastatic breast cancer
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have known or strongly suspected breast cancer, either early or spread to other parts of the body.
- Have a spot where the doctor can safely take a tissue sample, called a biopsy.
- Be at least 18 years old.
- Be able to care for yourself and be out of bed for more than half of your waking hours (ECOG score 0–2).
- Be able to understand the study and willing to sign a consent form.
- If taking blood thinners for treatment, stop them before the biopsy for as long as the study doctor says.
- For a biopsy of an organ such as the lung or liver, have enough infection-fighting white blood cells and platelets, which help blood clot: neutrophils at least 1.5 × 10⁹/L and platelets at least 100 × 10⁹/L.
Who can't join
- Have an illness or condition that makes joining the study unsafe or unsuitable.
- Have dementia, confusion, or a mental health condition that prevents understanding or giving consent.
- Have had a serious or life-threatening allergic reaction to numbing drugs such as lidocaine or xylocaine.
- Be pregnant, because some biopsy medicines or scan radiation may harm the mother or unborn baby.
- Have heart disease that makes a biopsy unsafe, in the treating doctor's opinion.
- For a lung, liver, or other vital organ biopsy: have taken bevacizumab or another drug that blocks new blood vessel growth less than 6 weeks ago.
- For a breast, outer lymph node, or small skin biopsy: have taken one of these blood vessel-blocking drugs less than 2 weeks ago.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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.
Study sites (1)
NC
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill · Chapel Hill, NC 27599-7295Clinical Trials Office - Lineberger Comprehensive Cancer Cente · Study contact · 877-668-0683More trials in Chapel Hill