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Breast Cancer Active Surveillance, Alternative Option, Aspirin Included

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03491410
Enrollment
60
Registered
2018-04-09
Start date
2018-06-01
Completion date
2023-05-31
Last updated
2018-04-09

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

Conditions

Breast Cancer

Keywords

Metastatic, Active Surveillance

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.

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

Interventions

DRUGAspirin Low Dose

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

DRUGPlacebo Oral Tablet

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

Sponsors

Centro Hospitalar Lisboa Ocidental
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
Overall Survival3 yearsPatients Overall survival in arm 2 superior to the arm 1

Secondary

MeasureTime frameDescription
Metastatic Disease Stability1 yearMetastatic disease stability (non progression) determined by imaging (ecography, CT,PET-CT or Bone Scintigraphy) in arm 2 superior to the arm 1
Tumor response till patient decides to exit the active surveillance6 monthsTumor response till patient decides to exit the active surveillance

Contacts

Primary ContactVasco Fonseca, MD
medicinavf@yahoo.com210 431 704/18

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026