Comparison of efficacy and safety of Diphereline 11.25 mg, Microreline 11.25 mg, and Microreline 3.75mg in premenopausal breast cancer patients

Comparison of efficacy and safety of Diphereline 11.25 mg, Microrelin 11.25 mg, and 3.75mg in premenopausal breast cancer patients.

A three-arm parallel randomized clinical trial without a control group, single-blind, fourth phase on 210 patients, randomization will be done by the random block method and MS EXCEL.

This study will be performed at the Breast Cancer Research Center. Before starting systemic therapy, the serum estradiol levels in the three groups will be measured. Then, serum estradiol levels will be measured at the end of the third month in quarterly drug groups and the end of all three injections for monthly drug, and it will be compared in three groups. All patients will be clinically evaluated during treatment in terms of menopause, the interval between menstruation and injection, spotting, and the ability to menopause (menopause and serum estradiol level below 5-10 µ g/ml), then will be compared in three groups. This process will be continued in the sixth, ninth and twelfth months (at the end of the first year) of medicine use ( 5 times in total). Menopausal symptoms, including hot flashes, vaginal dryness, and the number of hot flashes per day, shivering, and dyspareunia symptoms will be asked and recorded in a table every three months, respectively. At the end of the study, the ability to induce menopause in the two groups with the above factors will be compared.

Age over 18 years Positive estrogen and progesterone receptor Premenopausal patients Perimenopausal patients, If the estradiol levels are similar to premenopausal women.

Quarterly Diphereline group Quarterly Microreline group Monthly Microreline group

Changes in estradiol levels over one year.

After enrolling subjects in the study, they will assign one of the three study groups using the random six-block method. Before the intervention, a statistician prepared 35 sets of BBCAAC, BCAACB, CCAABB, etc., modes using MS Excel. The letters A, B, and C will be each symbol of one of the study groups by using the draw. Each code of six will be enclosed in a sealed envelope that cannot be read from the envelope. When the patients are visited, one of the envelopes will be randomly selected, and on the order of the letters mentioned in it, the patients will be assigned to one of the study arms.

Since the randomization will be done by the relevant person in charge of the clinic, and the recording of the tests and complications will be done by a follow-up physician, in quarterly drug injection groups, the subjects, the observer (oncologist and nurse), and the analyzer will not know the type of drug. In the one-month injection group, it will not be possible to blind the subject and the observer.