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Breast Cancer Active Surveillance, Alternative Option, Aspirin Included

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Aspirin Low Dose

Placebo Oral Tablet

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Metastatic, Active Surveillance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm Description

Arm 1: standard Unit´s protocol + placebo

Arm 2: standard Unit´s protocol + aspirin

Outcomes

Primary Outcome Measures

Overall Survival

Patients Overall survival in arm 2 superior to the arm 1

Secondary Outcome Measures

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

Tumor response till patient decides to exit the active surveillance

Full Information

NCT ID

NCT03491410

First Posted

March 22, 2018

Last Updated

April 6, 2018

Sponsor

Centro Hospitalar Lisboa Ocidental

1. Study Identification

Unique Protocol Identification Number

NCT03491410

Brief Title

Breast Cancer Active Surveillance, Alternative Option, Aspirin Included

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2018 (Anticipated)

Primary Completion Date

December 31, 2019 (Anticipated)

Study Completion Date

May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centro Hospitalar Lisboa Ocidental

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Metastatic, Active Surveillance

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

Arm 1: standard Unit´s protocol + placebo

Arm Title

Arm Type

Experimental

Arm Description

Arm 2: standard Unit´s protocol + aspirin

Intervention Type

Drug

Intervention Name(s)

Aspirin Low Dose

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo Oral Tablet

Intervention Description

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

Primary Outcome Measure Information:

Title

Overall Survival

Description

Patients Overall survival in arm 2 superior to the arm 1

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Metastatic Disease Stability

Description

Metastatic disease stability (non progression) determined by imaging (ecography, CT,PET-CT or Bone Scintigraphy) in arm 2 superior to the arm 1

Time Frame

1 year

Title

Tumor response till patient decides to exit the active surveillance

Description

Tumor response till patient decides to exit the active surveillance

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Vasco Fonseca, MD

Phone

210 431 704/18

medicinavf@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zacharoula Sidiropoulou, MD

Organizational Affiliation

Centro Hospitalar Lisboa Ocidental

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

28597105

Citation

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.

Results Reference

background

PubMed Identifier

19519435

Citation

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.

Results Reference

result

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Breast Cancer Active Surveillance, Alternative Option, Aspirin Included

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