Breast Cancer Active Surveillance, Alternative Option, Aspirin Included

April 6, 2018 updated by: Zacharoula Sidiropoulou, Centro Hospitalar Lisboa Ocidental

Breast Cancer Active Surveillance Alternative Option, Can Aspirin Make the Difference?

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Breast cancer patients with diagnosis of Ductal or Lobular Invasive Carcinoma or CDis that refuse to underwent surgery or are not qualified for, and independently of age or of their actual staging, are going to be allocated, randomly and in double masked way to one of two arms:

Arm 1: standard Unit´s protocol + placebo Arm 2: standard Unit´s protocol + aspirin

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 3

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

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Every adult (above 18) y.o.patient with histologic diagnosis of Breast Cancer that refuse or is not suitable for surgical treatment, or with metastatic disease, remaining this way in an "active surveillance"

Exclusion Criteria:

Allergy or toxicity to aspirin

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 1
Arm 1: standard Unit´s protocol + placebo
Drug: Placebo Oral Tablet
Placebo is to be added in the standard patient´s treatment
EXPERIMENTAL: B
Arm 2: standard Unit´s protocol + aspirin
Drug: Aspirin Low Dose
Low-Dose Aspirin is to be added in the standard patient´s treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 3 years
Patients Overall survival in arm 2 superior to the arm 1
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metastatic Disease Stability
Time Frame: 1 year
Metastatic disease stability (non progression) determined by imaging (ecography, CT,PET-CT or Bone Scintigraphy) in arm 2 superior to the arm 1
1 year
Tumor response till patient decides to exit the active surveillance
Time Frame: 6 months
Tumor response till patient decides to exit the active surveillance
6 months

Collaborators and Investigators

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

Sponsor

Centro Hospitalar Lisboa Ocidental

Investigators

  • Principal Investigator: Zacharoula Sidiropoulou, MD, Centro Hospitalar Lisboa Ocidental

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 (ANTICIPATED)

June 1, 2018

Primary Completion (ANTICIPATED)

December 31, 2019

Study Completion (ANTICIPATED)

May 31, 2023

Study Registration Dates

First Submitted

March 22, 2018

First Submitted That Met QC Criteria

April 6, 2018

First Posted (ACTUAL)

April 9, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 9, 2018

Last Update Submitted That Met QC Criteria

April 6, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHLOBREASTASP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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