Breast Cancer Active Surveillance, Alternative Option, Aspirin Included

Centro Hospitalar Lisboa Ocidental

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Placebo Oral Tablet; Drug: Aspirin Low Dose

Study type: Interventional

Funder types: Other

Identifiers

NCT03491410

CHLOBREASTASP

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

60 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Arm 1: standard Unit´s protocol + placebo

Treatment:

Drug: Placebo Oral Tablet

B

Experimental group

Description:

Arm 2: standard Unit´s protocol + aspirin

Treatment:

Drug: Aspirin Low Dose