Breast Cancer Active Surveillance, Alternative Option, Aspirin Included

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03491410
• Other study ID #: CHLOBREASTASP
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: March 22, 2018
• Last updated: April 6, 2018
• Start date: June 1, 2018
• Est. completion date: May 31, 2023

Study information

• Verified date: March 2018
• Source: Centro Hospitalar Lisboa Ocidental
• Contact: Vasco Fonseca, MD
• Phone: 210 431 704/18
• Email: medicinavf[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 31, 2023
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Aspirin Low Dose
Low-Dose Aspirin is to be added in the standard patient´s treatment
• Placebo Oral Tablet
Placebo is to be added in the standard patient´s treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centro Hospitalar Lisboa Ocidental

References & Publications (2)

Chen 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. Review. — View Citation

Keibel A, Singh V, Sharma MC. Inflammation, microenvironment, and the immune system in cancer progression. Curr Pharm Des. 2009;15(17):1949-55. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	Patients Overall survival in arm 2 superior to the arm 1	3 years
Secondary	Metastatic Disease Stability	Metastatic disease stability (non progression) determined by imaging (ecography, CT,PET-CT or Bone Scintigraphy) in arm 2 superior to the arm 1	1 year
Secondary	Tumor response till patient decides to exit the active surveillance	Tumor response till patient decides to exit the active surveillance	6 months