Breast CancerNCT01000883
Correlation of Molecular Markers With Response to Therapy and Breast Cancer Behavior
An observational study of Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- biologic sample preservation procedure, laboratory biomarker analysis and biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 1998to Nov 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be selected from those individuals receiving diagnostic and treatment related biopsies at the University of North Carolina at Chapel Hill.
Who may be able to join
- 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.)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7295
Clinical Trials Office - Lineberger Comprehensive Cancer Cente, 877-668-0683
About this study
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
Read the detailed description
OBJECTIVES:
- Collect , catalogue, and store biological specimens from patients with locally advanced or metastatic breast cancer
- To collect clinical data from these patients containing identifiers, demographics, epidemiologic review, clinical evaluation, treatment, and long-term follow-up.
- To provide an efficient bi-directional flow of clinical information and specimens between laboratory and clinical scientists in order to foster innovative translational research.
OUTLINE: This is a multicenter study.
Patients undergo core biopsy and blood sampling at diagnosis, between chemotherapy regimens, and prior to definitive surgery. Tumor markers are assessed using immunohistochemistry and flow cytometry.
PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- biologic sample preservation procedure, laboratory biomarker analysis, biopsy
- Keywords
- stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biologic sample preservation procedureOther
approximately 16-20 milligrams of tumor tissue per core will be obtained for research purposes.
laboratory biomarker analysisOther
Evaluation of biomarkers will occur as questions are asked in subsequent correlative studies.
biopsyProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Generation of a biorepository for current and future correlative research studies
Measured: Diagnosis, between treatments,7-14 days after start of treatment and at time of definitive therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2009 (estimated)
- Study start1 Dec 1998
- Primary completionNov 2030 (estimated)
- Study completionNov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lisa A. Carey, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01000883
- Sponsor's protocol ID
- LCCC 9819
- Other IDs
- P50CA058223, P30CA016086, 05-2015 Also (05-MED-521-ORC)
- Status last verified
- Jun 2026
- First submitted
- 22 Oct 2009
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Molecular Markers With Response to Therapy and Breast Cancer Behavior
- ClinicalTrials.gov ID
- NCT01000883
- Acronym / sponsor ID
- LCCC 9819
- Conditions
- Breast Cancer
- Keywords
- stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent breast cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Dec 1998 (actual)
- Primary completion
- Nov 2030 (estimated)
- Study completion
- Nov 2032 (estimated)
- First posted
- 23 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
OBJECTIVES:
- Collect , catalogue, and store biological specimens from patients with locally advanced or metastatic breast cancer
- To collect clinical data from these patients containing identifiers, demographics, epidemiologic review, clinical evaluation, treatment, and long-term follow-up.
- To provide an efficient bi-directional flow of clinical information and specimens between laboratory and clinical scientists in order to foster innovative translational research.
OUTLINE: This is a multicenter study.
Patients undergo core biopsy and blood sampling at diagnosis, between chemotherapy regimens, and prior to definitive surgery. Tumor markers are assessed using immunohistochemistry and flow cytometry.
PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be selected from those individuals receiving diagnostic and treatment related biopsies at the University of North Carolina at Chapel Hill.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biologic sample preservation procedureapproximately 16-20 milligrams of tumor tissue per core will be obtained for research purposes. | Other | – |
| laboratory biomarker analysisEvaluation of biomarkers will occur as questions are asked in subsequent correlative studies. | Other | – |
| biopsycancer 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. | Procedure or surgery | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- web address for Lineberger Comprehensive Cancer Center at UNCLink provided by the sponsor.
- web address for the National Cancer InstituteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa A. Carey, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adrianna Warner ((919) 966-7847, adrianna_warner@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.