Immune Control of Breast Cancer Tumor Dormancy
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-000792
Sponsor Protocol Number: 15-000792
About this study
The Primary Aim of this study is to quantify BDTC in breast cancer patients at different stages of cancer. As part of this aim we will establish the proliferation status of the tumor cells. We will in parallel examine CTC to determine the correlation between BDTC and CTC. The Second Aim is to determine role of tumor associated immune responses in maintaining tumor dormancy. Knowledge gained will provide the rationale for an in depth study of breast cancer tumor dormancy and immune response. Ultimately, the information gained will help us to design of immune intervention strategies that prevent cancer recurrence.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
Cohort A
- Females age 18-90
- Able to give informed consent
- Planned breast surgical procedure
- Biopsy proven invasive breast cancer
- Breast cancer of clinical estimated size of > 2 cm in diameter or biopsy proven node positive disease, diagnosed by percutaneous core needle biopsy
Cohort B
- Females age 18-90
- Able to give consent
- Planned breast surgical procedure
- Biopsy proven invasive breast cancer
- Treated with 4+ cycles of neoadjuvant chemotherapy
Cohort C
- Females age 18-90
- Able to give consent
- Planned breast surgical procedure
- Biopsy proven invasive breast cancer
- Clinical stage IV disease (metastatic breast cancer)
Exclusion Criteria:
Cohort A
- Vulnerable subjects – pregnant women, children, prisoners, institutionalized individuals
- Benign breast disease
- Invasive cancer of < 2 cm in diameter and node negative
- Male patients
- Patients diagnosed with excisional or incisional biopsy
- Neoadjuvant endocrine or chemotherapy
- Platelet count of <150,000 plts/mcL (within 6 months)
Cohort B
- Vulnerable subjects – pregnant women, children, prisoners, institutionalized individuals
- Benign breast disease
- Male patients
- Patients diagnosed with excisional or incisional biopsy
- Neoadjuvant endocrine
- Platelet count of <150,000 plts/mcL (within 6 months)
Cohort C
- Vulnerable subjects – pregnant women, children, prisoners, institutionalized individuals
- Benign breast disease
- Male patients
- Platelet count of <150,000 plts/mcL (within 6 months)
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Judy Boughey, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available