Aspirin on CTCs of Advanced Breast and Colorectal Cancer
- Registration Number
- NCT02602938
- Lead Sponsor
- Zhejiang Provincial People's Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description aspirin Aspirin * 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.
- Primary Outcome Measures
Name Time Method Intervention completed 2 months 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.
- Secondary Outcome Measures
Name Time Method Disease progression 2 months 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.
Trial Locations
- Locations (1)
Zhejiang provincial people's hospital
🇨🇳Hangzhou, Zhejiang, China