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

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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


- 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

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.

Inclusion Criteria



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

- 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

- 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.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Generation of a biorepository for current and future correlative research studies

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Lisa A. Carey, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:

LCCC 9819



Start Date:

December 1998

Completion Date:

November 2016

Related Keywords:

  • Breast Cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms



Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Nash HeathcareRocky Mount, North Carolina  27804