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

This study is currently recruiting participants.
Verified January 2014 by UNC Lineberger Comprehensive Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01000883
First received: October 22, 2009
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention
Breast Cancer
Other: biologic sample preservation procedure
Other: laboratory biomarker analysis
Procedure: biopsy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Correlation of Molecular Markers With Response to Therapy and Breast Cancer Behavior

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Primary tumor and metastatic site tumor tissue; whole blood


Estimated Enrollment: 500
Study Start Date: December 1998
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: biologic sample preservation procedure
    approximately 16-20 milligrams of tumor tissue per core will be obtained for research purposes.
    Other: laboratory biomarker analysis
    Evaluation of biomarkers will occur as questions are asked in subsequent correlative studies.
    Procedure: 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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Criteria

DISEASE CHARACTERISTICS:

PATIENT ELIGIBILITY

Inclusion Criteria

  • Histologically proven metastatic breast cancer with measurable or evaluable disease per investigator discretion.
  • Patients must be 18 years of age or older. Women of child bearing potential must be practicing barrier or oral contraception for the duration of the study, or documented as surgically sterile or one year post-menopausal.
  • ECOG performance status 0-2
  • Cardiac function by MUGA with an EF > 45% or an echocardiogram that shows normal LV function.
  • Serum Creatinine < 2.0 mg/dl.
  • Hepatic transaminases (alanine aminotransferase (ALT) and aspartate aminotransferase (AST)) ≤3.0 times the upper limit of normal if no liver metastases or ≤5 times the upper limit of normal if liver metastases are present.
  • Bilirubin no more than 2X normal.
  • Seronegative for HIV.
  • Negative for Hepatitis B surface antigen.
  • Signed and dated informed consent.
  • HLA A0201+ by DNA genotyping.
  • Absolute neutrophil count greater than 1,500/mm3. Platelet count greater 100,000/mm3 and hemoglobin greater than or equal to 10
  • 3+ expression of HER-2/neu from original pathology (diagnostic) tumor sample by IHC or 2+ expression by IHC with gene amplification by FISH.
  • Patients will be eligible even if they have failed treatment for metastatic breast cancer with trastuzumab and a chemotherapy agent other than vinorelbine or if they have progressed within 12 months of receiving adjuvant chemotherapy using trastuzumab and a taxane.

Exclusion Criteria

  • Patients with any serious medical, cardiac, or psychiatric condition which, in the opinion of the investigator, would make the patient unsuitable for study participation or would impede probable compliance with the protocol.
  • Patients with central nervous system metastases must have stable disease for at least 3 months prior to study entry.
  • Patient is currently taking steroid medications. Systemic steroid treatment is not allowed.
  • Patients that have failed prior therapy with vinorelbine + trastuzumab will not be eligible for therapy.
  • Patient has received hormonal or cytotoxic chemotherapy within 14 days of apheresis and within 28-30 days prior to study treatment.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01000883

Contacts
Contact: Donna Rowe, RN (919) 966-7359 donna_rowe@med.unc.edu
Contact: Diane Winans (919) 843-2742 diane_winans@med.unc.edu

Locations
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599-7295
Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente    877-668-0683      
Nash Heathcare Recruiting
Rocky Mount, North Carolina, United States, 27804
Principal Investigator: Francisco Castillos, MD         
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
Principal Investigator: Lisa A. Carey, MD UNC Lineberger Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01000883     History of Changes
Other Study ID Numbers: LCCC 9819, P50CA058223, P30CA016086, 05-2015 Also (05-MED-521-ORC)
Study First Received: October 22, 2009
Last Updated: January 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014