Aspirin on CTCs of Advanced Breast and Colorectal Cancer (ACABC)

Zhejiang Provincial People's Hospital

Status and phase: Unknown; Phase 2

Conditions: Epithelial-Mesenchymal Transition; Circulating Tumor Cells

Treatments: Drug: Aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT02602938

2015KY163

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

aspirin

Experimental group

Description:

* 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.

Treatment:

Drug: Aspirin