Clinical trial NCT02602938: Aspirin on CTCs of Advanced Breast and Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Epithelial-Mesenchymal Transition
Circulating Tumor Cells
Keywords: aspirin
circulating tumor cells
metastatic breast cancer
metastatic colorectal cancer
Lead sponsor: Zhejiang Provincial People's Hospital
Sponsor class: OTHER
First posted: 2015-11-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Intervention completed
timeFrame: 2 months
Secondary outcomes:
measure: Disease progression
timeFrame: 2 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang provincial people's hospital
state: Zhejiang
Study officials:
References:
citation: 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.
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.
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.
citation: Yang L, Lv Z, Xia W, Zhang W, Xin Y, Yuan H, Chen Y, Hu X, Lv Y, Xu Q, Weng X, Ni C. The effect of aspirin on circulating tumor cells in metastatic colorectal and breast cancer patients: a phase II trial study. Clin Transl Oncol. 2018 Jul;20(7):912-921. doi: 10.1007/s12094-017-1806-z. Epub 2017 Dec 14.