Evaluation of Ki67 factor changes after 7 days treatment with Letrozol in postmenopausal women with an early stage breast cancer and hormone receptor positive
Evaluation of changes the cell proliferation factor (ki67%) before and after 7 days treatment with Letrozol in early stage breast cancer with hormone positive receptor
Design
This study will perform in one group (n = 40) with before-after evaluation. Randomization and blinding is not applicable in this study.
Settings and conduct
In university hospitals (Cancer Institute of Imam Khomeini Hospital, Arash Women's Hospital), patients should be on the waiting list for at least one week. In this study, one Letrozol tablet (2.5 mg/day) for 7 days before surgery will administer to patients. Ki67%factor is routinely measured in all patients undergoing core biopsy (before intervention) and after drug administration and surgery, the ki67% factor will be measured again by a pathologist. Ki67 levels will be measured at Imam Khomeini Hospital. Meanwhile, Letrozol will have long-term side effects such as hot flashes and vaginal bleeding, which logically will not occur with a one-week dose.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1. Breast cancer patients
2. Early stage of disease
3. Postmenopausal women
4. Hormone receptor positive
Exclusion criteria
1. Metastatic breast cancer
2. Other sub-types of breast cancer
3. Pre-menopausal women
Intervention groups
This study will perform in one group which evaluates before-after treatment. In patients who wait for the time of surgery, for 7 days Letrozol tablet will be prescribed (2.5 mg/day) and cell proliferation factor (ki67%) before and after treatment will measure.
Main outcome variables
Cell proliferation factor (ki67%) level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101104005101N2
Registration date:2022-05-10, 1401/02/20
Registration timing:retrospective
Last update:2022-05-10, 1401/02/20
Update count:0
Registration date
2022-05-10, 1401/02/20
Registrant information
Name
ramesh omranipour
Name of organization / entity
tehran university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1571
Email address
omranipour@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-25, 1398/12/06
Expected recruitment end date
2021-02-24, 1399/12/06
Actual recruitment start date
2020-02-25, 1398/12/06
Actual recruitment end date
2022-02-25, 1400/12/06
Trial completion date
2022-02-25, 1400/12/06
Scientific title
Evaluation of Ki67 factor changes after 7 days treatment with Letrozol in postmenopausal women with an early stage breast cancer and hormone receptor positive
Public title
Effect of Letrozol in cell proliferation marker of breast cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Breast caner patients
Early stage of disease
With hormone receptor positive
Postmenopausal women
Exclusion criteria:
Metastatic breast cancer
Premenopausal women
Other sub-types of breast cancer
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Before-after treatment in a single group
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Measurement of ki67% level at the beginning of the study (before intervention) and one week after using Letrozol tablet
Method of measurement
Ki-67 will be calculated using scoring systems to estimate a proliferation index (PI); the number of positively stained tumor nuclei divided by the total number of nuclei in a specific region by pathologists.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Prescription of Letrozol tablet (IRAN HORMONE PHRAMACEUTICAL CO.) 2.5 mg/day for 1 week before surgery and comparison of Ki67% level before and after drug consumption.