Primary objective of this study is to determine the effectiveness of goserelin acetate (Zoladex) in preserving ovarian function in premenopausal women undergoing adjuvant chemotherapy for primary invasive breast cancer by documenting persistence or resumption of regular menses via menstrual history, serum FSH and E2 measurements. The secondary objectives of this study are as follows: To investigate the impact of treatment with chemotherapy with or without goserelin acetate (i.e. impact of the expectation of ovarian function preservation) on participants' quality of life (QOL) by FACT-ES scale, and to compare safety and tolerability of study drugs in two treatment groups by evaluation of adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
102
3.6 mg depot injectable preparation
Research Site
Ankara, Turkey (Türkiye)
Research Site
Istanbul, Turkey (Türkiye)
Research Site
Kayseri, Turkey (Türkiye)
The ovarian function will be considered as regained, if E2 measurements return to premenopausal levels (equal to or above 20 pg/ml), FSH measurements return to premenopausal levels (less than or equal to 40 IU/L)
Time frame: Each 3 months
The ovarian function will be considered as regained, if menstrual bleeding is observed in two consecutive menstrual cycles
Time frame: Each 3 months
Quality of life (QOL) through-out the study measured by FACT-ES scale.
Time frame: Each 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.