Aspirin on CTCs of Advanced Breast and Colorectal Cancer

Circulating Tumor Cells Clinical Trial

— ACABC  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02602938
• Other study ID #: 2015KY163
• Status: Recruiting
• Phase: Phase 2
• First received: November 9, 2015
• Last updated: November 12, 2015
• Start date: November 2015
• Est. completion date: February 2017

Study information

• Verified date: November 2015
• Source: Zhejiang Provincial People’s Hospital
• Contact: Chao Ni, Doctor
• Phone: +8613989463951
• Email: davenc[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics committee of Zhejiang Provincial people's hospital
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

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

Intervention

Drug:
• Aspirin
Take aspirin (100mg) orally once a day for 2 months

Locations

Country	Name	City	State
China	Zhejiang provincial people's hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Provincial People’s Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

Ksiazkiewicz M, Markiewicz A, Zaczek AJ. Epithelial-mesenchymal transition: a hallmark in metastasis formation linking circulating tumor cells and cancer stem cells. Pathobiology. 2012;79(4):195-208. doi: 10.1159/000337106. Epub 2012 Apr 4. Review. — View Citation

Maity G, De A, Das A, Banerjee S, Sarkar S, Banerjee SK. Aspirin blocks growth of breast tumor cells and tumor-initiating cells and induces reprogramming factors of mesenchymal to epithelial transition. Lab Invest. 2015 Jul;95(7):702-17. doi: 10.1038/labinvest.2015.49. Epub 2015 Apr 13. — View Citation

Rothwell PM, Wilson M, Price JF, Belch JF, Meade TW, Mehta Z. Effect of daily aspirin on risk of cancer metastasis: a study of incident cancers during randomised controlled trials. Lancet. 2012 Apr 28;379(9826):1591-601. doi: 10.1016/S0140-6736(12)60209-8. Epub 2012 Mar 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes