Skip to main content
OpenTrials
Recruiting

NCT Number: NCT01503190

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

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Colorado Denver, Aurora, Colorado, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Females >18.
  • Histological or cytological confirmation of breast cancer.
  • 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.
  • 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.
  • Any clinical stage allowed.
  • 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.
  • Women treated at UCH, VVMC or SCC may be pregnant. Other participants are excluded for safety reasons.
  • 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.
  • 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

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

Treatment and study plan

Primary outcomes

  1. Progression Free Survival

    Time frame: Throughout study participation

    Prospective cohort study.

Study contacts

Contact information is provided by the study sponsor or research team.

Hannah Parris

CONTACT

[email protected]

720-848-4170

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2026
Study completion
2027
First posted
Jan 2, 2012
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.