The Immune System's Response to Young Women's Breast Cancer



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/12/2018
Start Date:July 21, 2009
End Date:July 2021
Contact:Emily Rozzo
Email:emily.rozzo@ucdenver.edu
Phone:303-724-6077

Use our guide to learn which trials are right for you!

A Translational Study of the Interactions Between Prior Pregnancy and the Biologic Subtype of Breast Cancer in Defining the Cancer: Host Immunologic Interaction

This study plans to learn more about the immune system's response to breast cancer in young
women.

The investigators will be looking at the level of immune suppression in different types of
breast cancer. The investigators will use blood, urine, and tissue samples from patients with
Pregnancy Associated Breast Cancer (PABC) versus non-PABC, as well as comparing different
types of breast cancer. If tissue sampling permits, the investigators may use some of the
breast cancer tissue to develop models for human cancer for drug targeting. Understanding the
immune response and suppression in different types of cancer will help us understand
mechanisms involved in breast cancer better and help the investigators in developing new
treatment in the future.

Inclusion Criteria:

1. Females >18.

2. Histological or cytological confirmation of breast cancer.

3. For patients diagnosed with needle core or excisional biopsy, formalin-fixed paraffin
embedded tumor blocks or unstained slides should be available or planned to be
available after upcoming procedure.

4. Patient should be willing to have fresh and/or fresh frozen tissue collected at time
of core biopsy, definitive breast cancer surgery or clinically planned breast cancer
metastasis biopsy/resection for research purposes as part of study procedures, if a
procedure is in the future planning of the patient's treatment.

5. Any clinical stage allowed.

6. Written informed consent obtained prior to any initiation of study procedures in the
case of subjects consented in clinic. Subjects consented outside of UCH, VVMC or SCC
will be consented by phone and verbal informed consent will be obtained prior to any
initiation of study procedures.

7. Women treated at UCH, VVMC or SCC may be pregnant. Other participants are excluded for
safety reasons.

8. Women who have commenced or completed their breast cancer treatment may join this
study by consenting to a retrospective tissue donation only consent of the protocol.

9. Women who receive their care at a facility other than UCH, VVMC or SCC may join this
study. These women will be consented utilizing the phone consent and will receive a
copy of the consent in the mail, or they will consent online and print a copy of their
online consent.

Exclusion Criteria:

1. Known significant autoimmune condition [ie Lupus, Crohne's disease or Rhuematoid
Arthritis], chronic oral steroid use, use of systemic immunomodulatory prescription
drugs for any medical condition.

2. The presence of other comorbid conditions known to significantly impact immune
function, (such as: type I diabetes, uncontrolled adult onset diabetes, severe COPD,
uncontrolled infection or known HIV infection.)

3. Underlying psychiatric condition which would, in the opinion of the investigator,
preclude compliance with study requirements

4. Subjects with a history of other malignancy besides current diagnosis of breast cancer
who were diagnosed and treated within the last 5 years are excluded, with exception of
cervical cancer definitively treated more than 2 years ago or non-melanomatous skin
cancer.
We found this trial at
1
site
13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Virginia Borges, MD, MMSc
Phone: 303-724-6077
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
?
mi
from
Aurora, CO
Click here to add this to my saved trials