Status:

COMPLETED

A Study of Effect of Megakaryocytes and Platelets in Breast Cancer

Lead Sponsor:

Mayo Clinic

Conditions:

Breast Cancer

Eligibility:

FEMALE

18+ years

Brief Summary

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

Detailed Description

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...

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

August 29 2023

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

April 29 2025

Estimated Enrollment :

23 Patients enrolled

Trial Details

Trial ID

NCT06011824

Start Date

August 29 2023

End Date

April 29 2025

Last Update

May 2 2025

Active Locations (1)

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Mayo Clinic Health System-Franciscan Healthcare

La Crosse, Wisconsin, United States, 54601

A Study of Effect of Megakaryocytes and Platelets in Breast Cancer | DecenTrialz