Pregnancy's hidden clues: could past pregnancies shape breast cancer outcomes?
NCT ID NCT01503190
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how a woman's past pregnancies may change her immune system's response to breast cancer. Researchers will follow 800 young women with breast cancer to see if pregnancy history affects how long they live without the cancer getting worse. The goal is to better understand the link between pregnancy, immune function, and breast cancer subtypes.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 800 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2009
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Women over the age of 18 who have been diagnosed with breast cancer. Women over age 46 will serve as controls. Need not be in active treatment.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Denver Health Hospital Authority
RECRUITINGDenver, Colorado, 80204, United States
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UCHealth Cherry Creek Medcial Center
RECRUITINGDenver, Colorado, 80206, United States
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UCHealth Highlands Ranch Hospital
RECRUITINGHighlands Ranch, Colorado, 80129, United States
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UCHealth Lone Tree Medical Center
RECRUITINGLone Tree, Colorado, 80124, United States
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University of Colorado Denver
RECRUITINGAurora, Colorado, 80045, United States
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Other studies related to the condition(s) this trial covers.
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