Recruiting

Observational Study

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT01000883

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

biologic sample preservation procedure

laboratory biomarker analysis

biopsy

Study Details

Brief summary:

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

Conditions

Breast Cancer

Study ID

NCT01000883

Start date

Dec 1, 1998

Status verified date

Jun, 2026

Completion date

Nov, 2032

Anticipated

Primary completion date

Nov, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10000 participants

Anticipated

Interventions and Outcome Measures

Interventions

biologic sample preservation procedure

approximately 16-20 milligrams of tumor tissue per core will be obtained for research purposes.

laboratory biomarker analysis

Evaluation of biomarkers will occur as questions are asked in subsequent correlative studies.

biopsy

cancer tissue will be taken from the primary breast cancer site as well as the metastatic tumor sites. Two tubes of whole blood will also be collected.

Primary outcome measure

  • Generation of a biorepository for current and future correlative research studies [ Time Frame: Diagnosis, between treatments,7-14 days after start of treatment and at time of definitive therapy ]

Central Contacts and Locations

Locations

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599-7295

Contacts

Clinical Trials Office - Lineberger Comprehensive Cancer Cente

877-668-0683

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Keywords

  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • recurrent breast cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-06-25.