Skip to content

Aspirin on CTCs of Advanced Breast and Colorectal Cancer

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02602938
Acronym
ACABC
Enrollment
40
Registered
2015-11-11
Start date
2015-11-30
Completion date
2017-02-28
Last updated
2015-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circulating Tumor Cells, Epithelial-Mesenchymal Transition

Keywords

aspirin, circulating tumor cells, metastatic breast cancer, metastatic colorectal cancer

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.

Interventions

DRUGAspirin

Take aspirin (100mg) orally once a day for 2 months

Sponsors

Zhejiang Provincial People's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intervention completed2 months2-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

MeasureTime frameDescription
Disease progression2 monthsThe 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.

Countries

China

Contacts

Primary ContactChao Ni, Doctor
davenc@163.com+8613989463951
Backup ContactYun Chen, Doctor
hlqm1986@163.com+8613858087167

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026