MedTrace Logo

Breast Cancer Active Surveillance, Alternative Option, Aspirin Included

NCT03491410 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-04-09

No results posted yet for this study

Summary

Experimental, clinical, and epidemiological studies have all demonstrated the strong association between chronic inflammation and cancer, and many studies have correlated the prolonged presence of the inflammatory milieu with an increased risk for developing cancer.(1) Although the potential mechanism for aspirin preventing breast cancer is not known, possible pathways may involve platelets, inflammation, cyclooxygenase (COX) 2, hormones, or PI3 kinase. (2).

In actual clinical practice there exist clear guidelines for the use of aspirin in colorectal cancer but no such guidelines exist for the use of aspirin in breast cancer patients.

In the Unit´s proper experience, in patients under active surveillance and metastatic ones some present very good responses both in the neoadjuvant and in the metastatic setting but investigators intend to provide evidence and not just the experience. This study patients are proposed to combine their standard treatment with aspirin.

Conditions

Interventions

DRUG

Aspirin Low Dose

Low-Dose Aspirin is to be added in the standard patient´s treatment

DRUG

Placebo Oral Tablet

Placebo is to be added in the standard patient´s treatment

Sponsors & Collaborators

  • Centro Hospitalar Lisboa Ocidental

    lead OTHER_GOV

Principal Investigators

  • Zacharoula Sidiropoulou, MD · Centro Hospitalar Lisboa Ocidental

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2019-12-31
Completion
2023-05-31

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03491410 on ClinicalTrials.gov