A Study of Effect of Megakaryocytes and Platelets in Breast Cancer

NCT ID: NCT06011824

Last Updated: 2025-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-29

Study Completion Date

2025-04-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Determining if Megakaryocytes and Platelets are Harmful or Helpful in Breast Cancer Cell Metastasis

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The purpose of this study is to determine how megakaryocytes (cells in the bone marrow responsible for making platelets, which are necessary for blood clotting) affect the survival and growth/division patterns of breast cancer stem cells, and the effects of breast cancer cells on megakaryocyte survival and function. Through chart review, the study team will look at the relationship between different blood components and different breast cancer diagnoses.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Biopsy Negative

Female age 18 and above with negative breast biopsy

Blood draw

Intervention Type OTHER

10-12mL of blood will be drawn one time, unless a redraw is needed, in which case up to 24 mL will be drawn (10-12 mL each draw)

Biopsy positive for carcinoma in situ (ductal, lobular, or other)

Females age 18 and above with any subtype of breast cancer (ductal, lobular, or other)

Blood draw

Intervention Type OTHER

10-12mL of blood will be drawn one time, unless a redraw is needed, in which case up to 24 mL will be drawn (10-12 mL each draw)

Biopsy positive for Stage 1, 2, or 3 invasive carcinoma (ductal, lobular, or other)

Females age 18 and above with any subtype of breast cancer (HER2+, ER/PR, TNBC, BRCA1 +/-, other).

Blood draw

Intervention Type OTHER

10-12mL of blood will be drawn one time, unless a redraw is needed, in which case up to 24 mL will be drawn (10-12 mL each draw)

Metastatic Stage IV

Females age 18 and above with any subtype of breast cancer, including metastases

Blood draw

Intervention Type OTHER

10-12mL of blood will be drawn one time, unless a redraw is needed, in which case up to 24 mL will be drawn (10-12 mL each draw)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Blood draw

10-12mL of blood will be drawn one time, unless a redraw is needed, in which case up to 24 mL will be drawn (10-12 mL each draw)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Cohort 1-Biopsy negative

* Females age 18 and above

Cohort 2-Biopsy positive for carcinoma in situ (ductal, lobular, or other)

* Females age 18 and above
* Any subtype of breast cancer

Cohort 3-Biopsy positive for Stage 1, 2, or 3 invasive carcinoma (ductal, lobular, or other)

* Females age 18 and above
* Any subtype of breast cancer
* Have no distant metastases

Cohort 4-Stage 4 Metastatic Disease

* Females age 18 and above
* Any subtype of breast cancer

Exclusion Criteria

* Previous diagnosis with a known platelet disorder such as: Bernard Soulier disease, Jacobsen syndrome, Lowe syndrome, Thrombocytopenia, Thrombotic thrombocytopenic pupura, Von Willebrand disease, or the equivalent. Any condition in which antiplatelet or anticoagulant therapy with one of the following medications is being prescribed: Clopidogrel (Plavix), Warfarin (Coumadin or Jantoven), Prasugrel (Effient), or Ticagrelor (Brilinta).

Cohort 1-Biopsy negative

* Males
* Females less than age 18

Cohort 2-Biopsy positive for carcinoma in situ (ductal, lobular, or other)

* Males
* Females less than age 18
* Currently undergoing neoadjuvant therapy

Cohort 3-Biopsy positive for Stage 1, 2, or 3 invasive carcinoma (ductal, lobular, or other)

* Males
* Females less than age 18
* Presence of distant metastases
* Currently undergoing neoadjuvant therapy

Cohort 4-Stage 4 Metastatic Disease

* Males
* Females less than age 18
* Currently undergoing neoadjuvant therapy
* Less than 30 days from last adjuvant treatment for Stage I-III Breast Cancer (may be on Trastuzumab, Pertuzumab, or endocrine therapy only for maintenance therapy from their prior breast cancer diagnosis)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Scott H. Okuno, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic Health System-Franciscan Healthcare

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mayo Clinic Health System-Franciscan Healthcare

La Crosse, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2023-06775

Identifier Type: REGISTRY

Identifier Source: secondary_id

23-004958

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.