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Breast Cancer Active Surveillance, Alternative Option, Aspirin Included

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ClinicalTrials.gov Identifier: NCT03491410
Recruitment Status : Not yet recruiting
First Posted : April 9, 2018
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Zacharoula Sidiropoulou, Centro Hospitalar Lisboa Ocidental

Brief 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.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Aspirin Low Dose Drug: Placebo Oral Tablet Phase 2 Phase 3

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Breast Cancer Active Surveillance Alternative Option, Can Aspirin Make the Difference?
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Aspirin

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




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 3 years ]
    Patients Overall survival in arm 2 superior to the arm 1


Secondary Outcome Measures :
  1. 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

  2. Tumor response till patient decides to exit the active surveillance [ Time Frame: 6 months ]
    Tumor response till patient decides to exit the active surveillance



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491410


Contacts
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Contact: Vasco Fonseca, MD 210 431 704/18 medicinavf@yahoo.com

Sponsors and Collaborators
Centro Hospitalar Lisboa Ocidental
Investigators
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Principal Investigator: Zacharoula Sidiropoulou, MD Centro Hospitalar Lisboa Ocidental

Publications of Results:
Other Publications:
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Responsible Party: Zacharoula Sidiropoulou, Principal Investigator, Centro Hospitalar Lisboa Ocidental
ClinicalTrials.gov Identifier: NCT03491410     History of Changes
Other Study ID Numbers: CHLOBREASTASP
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Zacharoula Sidiropoulou, Centro Hospitalar Lisboa Ocidental:
Metastatic
Active Surveillance
Additional relevant MeSH terms:
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Aspirin
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics