Investigation of the effect of aspirin on pathological response of neoadjuvant chemotherapy in breast cancer patients referred to Kerman Afzalipur Hospital in 2024-2025
Design
The current study will be a triple-blinded randomized clinical trial that will be conducted in Afzalipur Hospital, Kerman, during the years 2024 and 2025. The target population of this study will be women with breast cancer referred to the radio-oncology department of Afzalipur Hospital.
Settings and conduct
This study will follow a triple blind design. In this way, neither the participants, nor the researchers involved in data collection, nor the statistical analyst of the project will be aware of the group to which the patients have been assigned. The location of this study is Afzalipur Hospital.
Participants/Inclusion and exclusion criteria
1. Women aged 18 to 70 with breast cancer who have been confirmed by histopathological diagnosis
2. Stage II to III who are candidates for neoadjuvant chemotherapy
3. Zero or one ECOG performance index
4. Informed consent to enter the study
Intervention groups
In this study, all patients will receive standard neoadjuvant chemotherapy regimens based on the hemato-oncology specialist's prescription. Chemotherapy regimens will include regimens based on cyclophosphamide, adriamycin, and taxols.
Participants who meet the inclusion and exclusion criteria of the study will be randomly assigned 1:1 to receive aspirin or placebo during their neoadjuvant chemotherapy treatment.
Main outcome variables
Primary outcome pathological complete response
Secondary outcome side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241015063367N1
Registration date:2024-12-16, 1403/09/26
Registration timing:registered_while_recruiting
Last update:2024-12-16, 1403/09/26
Update count:0
Registration date
2024-12-16, 1403/09/26
Registrant information
Name
Roghaye Abdollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3325 7236
Email address
roghayeabdollahi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-22, 1403/08/01
Expected recruitment end date
2025-04-20, 1404/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the therapeutic effect of aspirin in combination with standard chemotherapy regimens compared to placebo in breast cancer
Public title
Investigating the effect of aspirin in breast cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Women aged 18 to 70 with breast cancer who have been confirmed by histopathological diagnosis
2. Stage II to III who are candidates for neoadjuvant chemotherapy
3. Zero or on Eastern Cooperative Oncology Groupperformance index
4. Informed consent to enter the study
Exclusion criteria:
1. Patients with a history of other malignancies, a history of myocardial infarction, a history of atrial fibrillation, and a history of grade hypertension
2. Contraindications of aspirin use
3. Simultaneous use of warfarin, heparin or heparin analogues, clopidogrel, thrombin inhibitors or coagulation factors
4. History of taking aspirin within 30 days before entering the study
Age
From 18 years old to 70 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, all patients will receive standard neoadjuvant chemotherapy regimens based on the prescription of a hemato-oncology specialist. Chemotherapy regimens will include regimens based on cyclophosphamide, adriamycin, and taxols.
Participants who meet the inclusion and exclusion criteria of the study will be randomly assigned 1:1 to receive aspirin or placebo during their neoadjuvant chemotherapy treatment after obtaining informed consent and explaining the research objectives. Randomization will be performed using a computerized randomization sequence. Patients in the intervention group will be treated with aspirin 100 mg daily during the period of neoadjuvant chemotherapy. Patients in the control group are similarly receiving placebo daily during the period of neoadjuvant chemotherapy. The placebo will be delivered to the patients in the control group in capsules with the same appearance as aspirin but without the effective pharmacological substance. The distribution of patients in the two groups is similar in terms of disease stage and hormone receptor
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study will follow a triple blind design. In this way, neither the participants, nor the researchers involved in data collection, nor the statistical analyst of the project will be aware of the group to which the patients have been assigned. Aspirin and placebo capsules will look identical. A third party not involved in the measurement of outcomes and analysis of results will be responsible for labeling the study drugs according to the randomized sequence and maintaining the blinding process of the study until the end of the data analysis. Unblinding will only be done if a medical emergency occurs during the study for the patient that requires knowledge of the prescribed treatment, in which case the patient will be excluded from the study.
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of kerman University of Medical Sciences
Street address
Emam khomeini
City
Kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۳۵۵
Approval date
2024-09-23, 1403/07/02
Ethics committee reference number
IR.KMU.AH.REC.1403.109
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Complete pathologic response
Timepoint
4 month
Method of measurement
Pathology report
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: after obtaining informed consent and explaining the objectives of the research, aspirin 81 milligrams daily is given to the intervention group
Category
Treatment - Other
2
Description
Control group: A placebo is given to the control group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipur hospital
Full name of responsible person
Maryam Bahador
Street address
Emam Khomeini
City
Kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۳۵۵
Phone
+98 34 3132 8000
Email
roghayeabdollahi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Saeed Ahmadzade
Street address
Imam Highway, Afzalipur Hospital
City
Kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۳۵۵
Phone
+98 34 3132 8000
Email
roghayeabdollahi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Roghaye Abdollahi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Imam Highway, Afzalipur Hospital
City
Kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۳۵۵
Phone
+98 34 3132 8000
Email
roghayeabdollahi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Maryam Bahador
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Radiotherapy
Street address
Emam Khomeini
City
Kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۳۵۵
Phone
+98 34 3132 8000
Email
maryamb2003@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Roghaye Abdollahi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiotherapy
Street address
Emam Khomeini
City
Kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۳۵۵
Phone
+98 34 3132 8000
Email
roghayeabdollahi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
On website
When the data will become available and for how long
After publishing
To whom data/document is available
Every one
Under which criteria data/document could be used
For searching, treatment
From where data/document is obtainable
Internet
Email roghayeabdollahi@yahoo.com
What processes are involved for a request to access data/document