NCT03491410

Breast Cancer Active Surveillance, Alternative Option, Aspirin Included

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Centro Hospitalar Lisboa Ocidental · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-06-01
• Primary completion: 2019-12-31
• Completion: 2023-05-31
• First posted: 2018-04-09
• Last updated: 2018-04-09