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

Recruiting

• Conditions: Breast Cancer; Breast Cancer and Pregnancy

• Registration Number: NCT01503190
• Lead Sponsor: University of Colorado, Denver

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2009-07-21
• Study First Submitted: 2011-12-29
• Study First Submitted QC: 2011-12-30
• Study First Posted: 2012-01-02
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-09
• Primary Completion: 2026-12
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 800

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	Throughout study participation	Prospective cohort study.

Trial Locations

Locations (5)

Denver Health Hospital Authority; 🇺🇸 Denver, Colorado, United States

UCHealth Cherry Creek Medcial Center; 🇺🇸 Denver, Colorado, United States

UCHealth Highlands Ranch Hospital; 🇺🇸 Highlands Ranch, Colorado, United States

UCHealth Lone Tree Medical Center; 🇺🇸 Lone Tree, Colorado, United States

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States