Aspirin on CTCs of Advanced Breast and Colorectal Cancer (ACABC)

November 12, 2015 updated by: Chao Ni, Zhejiang Provincial People's Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Chao Ni, Doctor
  • Phone Number: +8613989463951
  • Email: davenc@163.com

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310014
        • Recruiting
        • Zhejiang Provincial People's Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Aspirin
Take aspirin (100mg) orally once a day for 2 months
Other Names:
  • acetylsalicylic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention completed
Time Frame: 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.
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease progression
Time Frame: 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.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang Provincial People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

February 1, 2017

Study Registration Dates

First Submitted

November 9, 2015

First Submitted That Met QC Criteria

November 10, 2015

First Posted (Estimate)

November 11, 2015

Study Record Updates

Last Update Posted (Estimate)

November 13, 2015

Last Update Submitted That Met QC Criteria

November 12, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015KY163

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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