Understanding the immune response in young women with breast cancer
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 looks at how the immune system reacts to breast cancer in young women, especially those diagnosed during or after pregnancy, to help find better treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 5 sites (Aurora, Colorado and 4 other locations) |
| Trial ID | NCT01503190 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the immune system's response to breast cancer in young women, particularly focusing on those with Pregnancy Associated Breast Cancer (PABC). Researchers will analyze blood, urine, and tissue samples from patients with PABC and compare them to those with non-PABC, as well as different types of breast cancer. The study may also involve developing models for human cancer to aid in drug targeting, enhancing our understanding of immune suppression in various breast cancer types. The ultimate goal is to uncover mechanisms involved in breast cancer to inform future treatment development.
Who should consider this trial
Good fit: Ideal candidates include females over 18 with a confirmed diagnosis of breast cancer, including those who may be pregnant.
Not a fit: Patients who do not have breast cancer or are male will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment options for young women with breast cancer.
How similar studies have performed: While there have been studies on immune responses in breast cancer, this specific focus on young women and pregnancy-associated cases is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Aurora, Colorado and 4 other locations
- University of Colorado Denver — Aurora, Colorado, United States (Recruiting)
- Denver Health Hospital Authority — Denver, Colorado, United States (Recruiting)
- UCHealth Cherry Creek Medcial Center — Denver, Colorado, United States (Recruiting)
- UCHealth Highlands Ranch Hospital — Highlands Ranch, Colorado, United States (Recruiting)
- UCHealth Lone Tree Medical Center — Lone Tree, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Virginia Borges, MD, MMSc — University of Colorado, Denver
- Study coordinator: Hannah Parris
- Email: hannah.parris@cuanschutz.edu
- Phone: 720-848-4170
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.