NCT00477139

Brief Summary

This is a pilot study to gather preliminary data on the baseline immunologic status of patients with HER-2(+) breast cancer and to establish an immune monitoring laboratory for future clinical trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 22, 2007

Completed
1.6 years until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

April 13, 2011

Status Verified

April 1, 2011

Enrollment Period

1.7 years

First QC Date

May 18, 2007

Last Update Submit

April 11, 2011

Conditions

Breast Cancer

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

individuals with HER-2 positive breast cancer.

You may qualify if:

  • Age \>= 18 years of age
  • Histologically documented breast cancer (hormone receptor (ER/PR) status may be either positive or negative) with or without metastatic disease.
  • HER-2(+) as determined by one of the following measurements. NOTE: HER-2(+) assessment may have been on initial diagnosis and need not be repeated for metastatic lesions
  • Immunohistochemistry (IHC) 3+, or
  • FISH + (HER-2 gene signal to centromere 17 signal \>2)
  • No transfusion dependent patients and no transfusion within 30 days of leukopheresis
  • Documented labs within 7 days of donation consisting of:
  • WBC \> 4.0 K/ul \& \< 11.0 K/ul
  • platelet count \> 150,000/mm3
  • hemoglobin \> 11.0 g/dl.
  • Hematocrit \> 33 %
  • Weight \> 110 lbs
  • No blood donation in last 8 weeks (blood samples taken for standard of care less then 30 cc/week are acceptable)
  • Patients must not have active or unresolved infection.
  • No cold or flu sympton at time of donation
  • +4 more criteria

You may not qualify if:

  • The presence of another active malignancy
  • Pregnant, lactating, or nursing
  • Patients with prior myocardial infarction or active cardiac disease (e.g. congestive heart failure, clinically significant cardiac valvular disease or arrhythmia requiring medications, angina pectoris, uncontrolled hypertension, clinically significant pericardial effusion)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Dr. Ellie Guardino MD/PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 18, 2007

First Posted

May 22, 2007

Study Start

January 1, 2009

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

April 13, 2011

Record last verified: 2011-04

Locations

US(1)