Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT01503190

Conditions

Breast Cancer

Breast Cancer and Pregnancy

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Conditions

Breast Cancer

Breast Cancer and Pregnancy

Study ID

NCT01503190

Start date

Jul 21, 2009

Status verified date

Jan, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

800 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Progression Free Survival [ Time Frame: Throughout study participation ]

Central Contacts and Locations

Central contacts

Locations

University of Colorado Denver

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Principal Investigator:

Virginia Borges, MD, MMSc

Denver Health Hospital Authority

Recruiting

Denver, Colorado, United States, 80204

Contacts

UCHealth Cherry Creek Medcial Center

Recruiting

Denver, Colorado, United States, 80206

Contacts

UCHealth Highlands Ranch Hospital

Recruiting

Highlands Ranch, Colorado, United States, 80129

Contacts

UCHealth Lone Tree Medical Center

Recruiting

Lone Tree, Colorado, United States, 80124

Contacts

More Information

Sponsor

University of Colorado, Denver

Last update posted

Jan 29, 2026

Last verified

Jan, 2026

Keywords

  • Breast Cancer
  • Young Women
  • Pregnancy Associated Breast Cancer
  • Pregnancy
  • Premenopausal Breast Cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-01-29.