Correlation of Molecular Markers With Response to Therapy and Breast Cancer Behavior

NCT01000883 | Recruiting DMC

• 4 other identifiers: LCCC 9819P50CA058223P30CA01608605-2015 Also (05-MED-521-ORC)
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Generation of a biorepository for current and future correlative research studies

  Diagnosis, between treatments,7-14 days after start of treatment and at time of definitive therapy

Interventions

biologic sample preservation procedure OTHER

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

laboratory biomarker analysis OTHER

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

biopsy PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be selected from those individuals receiving diagnostic and treatment related biopsies at the University of North Carolina at Chapel Hill.

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

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

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

RECRUITING

Related Links

• web address for Lineberger Comprehensive Cancer Center at UNC
• web address for the National Cancer Institute

Biospecimen

Retention: SAMPLES WITH DNA

Primary tumor and metastatic site tumor tissue; whole blood

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Lisa A. Carey, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrianna Warner

CONTACT

(919) 966-7847; adrianna_warner@med.unc.edu

Erin Kelly

CONTACT

(919) 966-0040; erin_kelly@med.unc.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2009
• First Posted: October 23, 2009
• Study Start: December 1, 1998
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): November 1, 2032
• Last Updated: June 18, 2025

Record last verified: 2025-06

Locations

US (1)