NCT03491410

Breast Cancer Active Surveillance, Alternative Option, Aspirin Included

Status unknown Phase 2, PHASE3 Last updated 9 April 2018

What this trial tests

Phase 2, PHASE3 trial testing Aspirin Low Dose in Breast Cancer in 60 participants. Status unknown.

Timeline

1 June 2018

Primary endpoint
31 December 2019

31 May 2023

Quick facts

Lead sponsor	Centro Hospitalar Lisboa Ocidental
Phase	Phase 2, PHASE3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	60
Start date	1 June 2018
Primary completion	31 December 2019
Estimated completion	31 May 2023

Drugs / interventions tested

• Aspirin Low Dose — full drug profile →
• Placebo Oral Tablet — full drug profile →

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Centro Hospitalar Lisboa Ocidental

Who can join

18 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Repurposing non-oncology small-molecule drugs to improve cancer therapy: Current situation and future directions.
   Fu L, Jin W, Zhang J, Zhu L, et al · · 2022 · cited 47× · PMID 35256933 · DOI 10.1016/j.apsb.2021.09.006