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Women Diagnosed Before 50 Needed for Study of Immune Response to Breast Cancer

Participants may be located anywhere in the U.S.

Trial Starts: July 2009; Trial Ends: No date set

Written By Robin Warshaw

Researchers seek women diagnosed before age 50 for a research study of immune suppression in breast cancer. Participants may be newly diagnosed, in treatment or any time past treatment.

About the Study

The researchers are aiming to better understand the biology at work in different types of breast cancer. This study will analyze how immune response—the body’s ability to defend itself from disease—and suppression (inhibiting or reducing that response) may influence varied breast cancer diagnoses.

Researchers will study urine, blood and stored tissue samples to measure immune responses. They will only analyze previously removed tissue from women who were diagnosed in the past.

Researchers will look at the influence of prior or current pregnancy on the development of breast cancer subtypes. They will compare responses in women diagnosed with pregnancy-associated breast cancer (PABC) to those with breast cancer not related to pregnancy.

Another goal of this study is to compare the occurrence of different breast cancer types in women with and without PABC.

The study may produce models for targeting medicines and could provide important information for developing new treatments.

Who Is Eligible to Participate?

Investigators hope to enroll 800 women in this study. It does not matter if you have ever been pregnant.

You may be able to take part if you are female and:

  • Between the ages of 18 and 49 when diagnosed with breast cancer of any stage or type
  • Are any of these:
    • Recently diagnosed but not yet in treatment
    • Currently in treatment
    • No longer in treatment (no time limit)
  • Live anywhere in the U.S.

Because of the study focus, women with autoimmune conditions or impaired immune function are not eligible to participate.

Study Location and Activities

Participants do not need to go to the study location, which is at the University of Colorado Cancer Center. After volunteering to participate, you will be interviewed by phone by the study’s research coordinator and be sent a consent form to sign.

Then:

  • If you are recently diagnosed and have not yet received treatment:
    • Collection and shipping materials for needed specimens will be provided to you
    • Specimens (blood and urine) may be collected during a doctor’s visit
    • The study coordinator will contact the hospital or cancer center where tissue was stored from your diagnostic testing to obtain a sample
  • If you already started treatment or are past treatment:
    • The study coordinator will contact the hospital or cancer center where tissue was stored from your diagnostic testing to obtain a sample
    • No blood or urine specimens will be needed

Contact Information

To participate, contact Beth Manthey, translational research coordinator, breast oncology, Young Women’s Breast Cancer Translational Program, University of Colorado Cancer Center, elizabeth.manthey@ucdenver.edu or call (720) 848-8031.

For more information, visit clinicaltrials.gov.

This article was supported by Cooperative Agreement Number DP11-1111 from The Centers for Disease Control and Prevention. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the Centers for Disease Control and Prevention.

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