Skip to main content
OpenTrials
Completed

NCT Number: NCT06011824

A Study of Effect of Megakaryocytes and Platelets in Breast Cancer

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Mayo Clinic Health System-Franciscan Healthcare

La Crosse, Wisconsin, 54601, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Blood Draw

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)

Primary outcomes

  1. Platelet Counts

    Time frame: Baseline

    Measure of the number of platelets in the blood, reported as platelets per microliter of blood.

Secondary outcomes

  1. Mean Corpuscular Volume (MCV)

    Time frame: Baseline

    Measures the average size of red blood cells, reported as femtoliters (fl).

  2. Lymphocyte to neutrophil ratio

    Time frame: Baseline

    Ratio between the neutrophil and lymphocyte counts measured in peripheral blood.

  3. Levels of tumor educated platelets

    Time frame: Baseline

    Number of tumor educated platelets, measured by the analysis of cell surface markers for expression of certain markers such as VEGF, PDGFR, MMP1, TGFb, and or other cell adhesion molecules.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Megakaryocytes and Platelets, Harmful or Helpful in Breast Cancer Cell Metastasis

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 25, 2023
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.