Clinical trial · Interventional
Breast Cancer Active Surveillance, Alternative Option, Aspirin Included
Breast Cancer Active Surveillance Alternative Option, Can Aspirin Make the Difference?
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aspirin Low Dose | Drug | Aspirin | ALIAS |
| Placebo Oral Tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- 1
- description
- Arm 1: standard Unit´s protocol + placebo
- interventionNames
- Drug: Placebo Oral Tablet
- type
- EXPERIMENTAL
- label
- B
- description
- Arm 2: standard Unit´s protocol + aspirin
- interventionNames
- Drug: Aspirin Low Dose
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- 3 years
- description
- Patients Overall survival in arm 2 superior to the arm 1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDChen WY, Holmes MD. Role of Aspirin in Breast Cancer Survival. Curr Oncol Rep. 2017 Jul;19(7):48. doi: 10.1007/s11912-017-0605-6. PMID 28597105
- RESULTKeibel A, Singh V, Sharma MC. Inflammation, microenvironment, and the immune system in cancer progression. Curr Pharm Des. 2009;15(17):1949-55. doi: 10.2174/138161209788453167. PMID 19519435