A Study of Effect of Megakaryocytes and Platelets in Breast Cancer

Mayo Clinic

Status: Completed

Conditions: Breast Cancer

Treatments: Other: Blood draw

Study type: Observational

Funder types: Other

Identifiers

NCT06011824

NCI-2023-06775 (Registry Identifier)

23-004958

Details and patient eligibility

About

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

Full 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 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.

Enrollment: 23 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

23 participants in 4 patient groups

Biopsy Negative

Description:

Female age 18 and above with negative breast biopsy

Treatment:

Other: Blood draw

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

Description:

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

Treatment:

Other: Blood draw

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

Description:

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

Treatment:

Other: Blood draw

Metastatic Stage IV

Description:

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

Treatment:

Other: Blood draw