Aspirin on CTCs of Advanced Breast and Colorectal Cancer — ACABC  

Circulating Tumor Cells Clinical Trial

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Circulating Tumor Cells
• Epithelial-Mesenchymal Transition
• Neoplastic Cells, Circulating

• NCT number: NCT02602938
• Study type: Interventional
• Source: Zhejiang Provincial People’s Hospital
• Contact: Chao Ni, Doctor
• Phone: +8613989463951
• Email: davenc@163.com
• Status: Recruiting
• Phase: Phase 2
• Start date: November 2015
• Completion date: February 2017