Breast Cancer Active Surveillance, Alternative Option, Aspirin Included

NCT03491410 | Unknown Phase 2 DMC

• 1 other identifier: CHLOBREASTASP
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Breast Cancer

Keywords

Metastatic; Active Surveillance

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Patients Overall survival in arm 2 superior to the arm 1

  3 years

Secondary Outcomes (2)

• Metastatic Disease Stability

  1 year

• Tumor response till patient decides to exit the active surveillance

  6 months

Study Arms (2)

1

PLACEBO COMPARATOR

Arm 1: standard Unit´s protocol + placebo

Drug: Placebo Oral Tablet

B

EXPERIMENTAL

Arm 2: standard Unit´s protocol + aspirin

Drug: Aspirin Low Dose

Interventions

Aspirin Low Dose DRUG

Low-Dose Aspirin is to be added in the standard patient´s treatment

B

Placebo Oral Tablet DRUG

Placebo is to be added in the standard patient´s treatment

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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"

You may not qualify if:

• Allergy or toxicity to aspirin

Sponsors & Collaborators

• Centro Hospitalar Lisboa Ocidental: lead

Related 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.

  PMID: 28597105 BACKGROUND

• Keibel 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 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Zacharoula Sidiropoulou, MD

  Centro Hospitalar Lisboa Ocidental

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vasco Fonseca, MD

CONTACT

210 431 704/18; medicinavf@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 22, 2018
• First Posted: April 9, 2018
• Study Start: June 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: May 31, 2023
• Last Updated: April 9, 2018

Record last verified: 2018-03