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The Immune System's Response to Young Women's 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how the immune system responds to breast cancer in young women. Women over age 18 with breast cancer at any stage may join.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women over age 18 whose breast cancer was confirmed by testing tissue or cells.
  • Breast cancer at any stage is allowed.
  • If cancer was diagnosed by a biopsy, stored tumor tissue or slides without stain must be available or expected after a planned procedure.
  • If a biopsy or cancer surgery is planned, you must agree to let researchers collect fresh or frozen tissue during it.
  • You must give consent before study steps begin. In-clinic consent is written. Participants outside UCH, VVMC or SCC may consent by phone or online.
  • Pregnant women may join only if treated at UCH, VVMC or SCC.
  • Women who have started or finished breast cancer treatment may join by agreeing to donate previously collected tissue only.
  • Women treated at other centers may join. They will get a copy of their consent by mail or print it online.

Who can't join

  • A major autoimmune disease, where the immune system attacks the body, such as lupus, Crohn's disease or rheumatoid arthritis.
  • Long-term use of steroids taken by mouth, or prescription drugs that affect the immune system throughout the body.
  • Other health problems that greatly affect the immune system, such as type 1 diabetes, uncontrolled adult-onset diabetes, severe COPD (a lung disease), uncontrolled infection or HIV.
  • A mental health condition that the study doctor believes would keep you from following study requirements.
  • Another cancer diagnosed and treated within the past 5 years. Exceptions are cervical cancer fully treated more than 2 years ago and skin cancer that is not melanoma.
  • Pregnancy if you are not treated at UCH, VVMC or SCC.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (5)

CO