Clinical trial NCT06011824: A Study of Effect of Megakaryocytes and Platelets in Breast Cancer
Official title: Megakaryocytes and Platelets, Harmful or Helpful in Breast Cancer Cell Metastasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Megakaryocytes
Platelets
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For the prospective study: 20 women after biopsy for suspicious mammogram findings, 10 women with newly diagnosed metastatic cancer.

Subject population (children, adults, groups): Women undergoing biopsy or suspicious mammogram finds and newly diagnosed female metastatic breast cancer patients.

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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Platelet Counts
timeFrame: Baseline
Secondary outcomes:
measure: Mean Corpuscular Volume (MCV)
timeFrame: Baseline
measure: Lymphocyte to neutrophil ratio
timeFrame: Baseline
measure: Levels of tumor educated platelets
timeFrame: Baseline
Other outcomes:
Locations:
city: La Crosse
country: United States
facility: Mayo Clinic Health System-Franciscan Healthcare
state: Wisconsin
Study officials:
affiliation: Mayo Clinic Health System-Franciscan Healthcare
name: Scott H. Okuno, M.D.
role: PRINCIPAL_INVESTIGATOR
References: