Aspirin on CTCs of Advanced Breast and Colorectal Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Aspirin could affect the number and subtype of circulating tumor cells of metastatic breast cancer and colorectal cancer.

Detailed Description
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BACKGROUND: Invasion and metastasis are the main reason of death in metastatic cancer, and abundant evidence find circulating tumor cells(CTCs) take the core position in breast and colorectal cancer metastasis. Platelets play multiple role to facilitate the epithelial to mesenchymal transition of tumor cells and protect CTCs to survival in the circulation, which enrolled in the whole process of metastasis. Several clinical trials and observational study have validate the primary and secondary prevention effect of aspirin to both breast and colorectal cancer. OBJECTIVES: Determine the effect of aspirin on CTC number of metastatic breast and colorectal cancer; Determine the effect of aspirin on CTC subtype (epithelial/mesenchymal/mixed type) of metastatic breast and colorectal cancer. ELIGIBILITY: Adults age from 18-75 years old. Patients were diagnosed for metastatic breast or colorectal cancer by pathology. Patients who were not currently receiving intravenous chemotherapy , oral administrated with capecitabine was permitted. Concurrent endocrine therapy ( for at least 2 months before enrollment), bisphosphonate therapy, and/or monoclonal targeted therapy were permitted. No disease of hemorrhagic tendency or history of non-steroid drug allergy. CTCs≥5 / 7.5ml blood STUDY DESIGN: Aspirin will be administered orally once a day in 28-day cycles. The CTC was evaluated every 28 days for 2 months.

Conditions
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Epithelial-Mesenchymal Transition, Circulating Tumor Cells

Intervention / Treatment
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* Drug: Aspirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults age from 18-75 years old. Patients were diagnosed for metastatic breast or colorectal cancer by pathology. Patients who were not currently receiving intravenous chemotherapy , oral administrated with capecitabine was permitted. Concurrent endocrine therapy ( for at least 2 months before enrollment), bisphosphonate therapy, and/or monoclonal targeted therapy were permitted. PS score ≤ 3 Anticipated survival time ≥ 3 months CTCs≥5 / 7.5ml blood Exclusion Criteria: Allergic to aspirin or other types of non-steroid History of hemorrhage of digestive tract or other hemorrhagic disease Plan to receive surgery within the time frame of the trial Medication history of aspirin or other types of anti-platelets drug within one months before the trial Women in pregnant or lactation period Any psychological or objective problem may influence the compliance of the patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aspirin<br>The included patients will be administered with aspirin (100mg) orally once a day in 28-day cycles. The CTC was evaluated at baseline, and every 28 days for 2 months. | Drug: Aspirin<br>* Take aspirin (100mg) orally once a day for 2 months<br>* Other names: acetylsalicylic acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention completed | 2-months follow-up completed and the CTCs' assessment was evaluated three times by Canpatrol technology, the tumor burden was evaluated by MRI or CT. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease progression | The tumor burden would be examined by MRI or CT once a month, if we find the cancer progressed and chemotherapy is needed, the patient will be withdraw. | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aspirin, circulating tumor cells, metastatic breast cancer, metastatic colorectal cancer