Event free survival
Time frame · From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
To compare the event-free survival (EFS) assessed by investigator in ITT population after neoadjuvant chemotherapy with/without ovary suppression
Quality of life from patient-report outcome
Time frame · At Screening phase, at Treatment 1 cycle 4 day 1 ( each cycle is 14 days or 21 days) , at Treatment 2 cycle 4 day 1 (each cycle is 14 days or 21 days), through study completion, an average of 5 years
Quality of life will be assessed by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 , the minimum values is : 30 , the maximum values is : 126, the higher scores mean a worse outcome
Estradiol
Time frame · At Screening phase, at Treatment 1 cycle 1 day 1, at Treatment 1 cycle 3 day 1, at Treatment 2 cycle 1 day 1, at Treatment 2 cycle 3 day 1, during surgery, through study completion, an average of 5 years
Estradiol (E2) pg/mL
Follicle stimulating hormone
Time frame · At Screening phase, at Treatment 1 cycle 1 day 1, at Treatment 1 cycle 3 day 1, at Treatment 2 cycle 1 day 1, at Treatment 2 cycle 3 day 1, during surgery, through study completion, an average of 5 years
Follicle stimulating hormone (FSH) mIU/mL
Luteinizing hormone
Time frame · At Screening phase, at Treatment 1 cycle 1 day 1, at Treatment 1 cycle 3 day 1, at Treatment 2 cycle 1 day 1, at Treatment 2 cycle 3 day 1, during surgery, through study completion, an average of 5 years
Luteinizing hormone (LH) mIU/mL
Tumor microenvironment changes after neoadjuvant chemotherapy with/without ovarian suppression
Time frame · At Screening phase, at Treatment 1 cycle 1 day 1 ( each cycle is 14 days or 21 days), at Treatment 2 cycle 1 day 1 ( each cycle is 14 days or 21 days), through study completion, an average of 5 years
To evaluate the tumor-infiltrating lymphocytes (TIL)
Pathological complete response by tumor infiltrating lymphocyte
Time frame · During surgery
To evaluate the rate of pCR (ypT0/Tis ypN0) as assessed by the local pathologist at the time of definitive surgery in individuals with TIL(+) or TIL(-) tumors.
Residual cancer burden
Time frame · During surgery
To evaluate Residual Cancer Burden (RCB) as assessed by the local pathologist at the time of definitive surgery
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame · up to 32 weeks
To determine the safety and tolerability of ovarian function suppression in combination with neoadjuvant chemotherapy in locally advanced TNBC subjects
Breast cancer quality of life from patient-report outcome
Time frame · At Screening phase, at Treatment 1 cycle 4 day 1 ( each cycle is 14 days or 21 days) , at Treatment 2 cycle 4 day 1 ( each cycle is 14 days or 21 days), through study completion, an average of 5 years
Breast cancer quality of life will be assessed by European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire BR23 , the minimum values is : 22 , the maximum values is : 92, the higher scores mean a worse outcome